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Targeting neurodegenerative diseases, Astrazeneca reaches nearly $900 million multi-year collaboration
Verge Genomics today announced a multi-target collaboration with Alexion, AstraZeneca's rare disease company, to identify novel drug targets for rare neurodegenerative and neuromuscular diseases。Under the terms of the four-year agreement, Vitech will receive up to $42 million, including an upfront payment, and potentially up to $8 million.4亿美元的里程碑款项。
Wix's proprietary ConVERGE platform combines highly predictive human tissue data sets with machine learning to identify emerging targets with the potential for higher clinical development success。Instead of starting with a cell or animal model, Wix's drug discovery platform is based on a proprietary library of genomic data sets derived directly from human tissue, coupled with an advanced, human-centered biology platform that rapidly advances new data insights into clinical therapy candidates。The ConVERGE platform aims to tackle diseases that are biologically difficult to break through, including:
Because multiple factors (genetic, environmental, and temporal) intersect in complex ways, the disease eventually becomes apparent。
Diseases in which human efficacy cannot be predicted by animal or cellular models。
Diseases where there is a high level of unmet need, where no treatments are currently available to alter the course of the disease, or where existing treatment modalities are significantly flawed。
The platform has been validated by the successful advancement of the pilot program for the treatment of amyotrophic lateral sclerosis (ALS) with Vitex。In October, the company announced that its investigational therapy, VRG50635, had completed the first trial in a phase 1 clinical trial。By evaluating more than 11.4 million data points obtained from ALS patient tissue and genetic databases, the ConVERGE platform identified loss of endosomal/lysosomal function as a novel pathogenic mechanism in ALS and identified PIKfyve as a potential new therapeutic target。VRG50635 is a potent PIKfyve targeted inhibitor that restores endosomal/lysosomal function of neurons in ALS patients。It has shown efficacy in multiple preclinical studies in models of ALS-associated motor neuron degeneration。
The press release noted at the time that VRG50635 is the first PIKfyve inhibitor to enter clinical development and is specifically optimized for the treatment of central nervous system diseases, including ALS, with "best-in-class" potential。
In this collaboration, the platform will be applied to identify innovative therapeutic targets for rare neurodegenerative and neuromuscular diseases。Alexion will select high-potential targets for each indication and select targets to advance success through clinical development and commercialization。
In an interview with Wuxi AppTec in 2018, Dr. Alice Zhang, the co-founder and CEO of Weizhi Gene, mentioned that the more chaotic the field, the more likely it is to be a place where machine learning and artificial intelligence can play a big role。Machine learning can make an important difference in solving the most complex disease problems。The progress of Vitex in the development of drugs for central nervous system diseases is the best validation of this insight。
According to the press release, this is the second cooperation between Vitech and a large pharmaceutical company。In July 2021, Vitech entered into a three-year, more than $700 million partnership with Eli Lilly and Company to research and develop novel therapies for amyotrophic lateral sclerosis。
Seagen"Hand in hand" Nurix, developing antibody coupling degraders
9Nurix today announced a collaboration with Seagen to co-develop antiboy-conjugated deactivator drugs (Dacs) for drugs with an entirely new mechanism of action, high specificity and anticancer activity。
NurixResponsible for using its DELigase technology platform to develop a suite of targeted protein degraders suitable for antibody coupling and multiple targets;Seagen is responsible for coupling these inhibitors with antibodies to synthesize Dacs and advancing these DAC candidates through preclinical, clinical development and commercialization。
Under the terms of the agreement, Nurix will receive an upfront payment of $60 million and the potential to earn approximately $3.4 billion in mileage payments and royalties across multiple projects, with Nurix retaining the option to share profits and co-promote the two products in the United States。
Compared with ADC and protein deactivators, DAC has the following advantages: 1) Replacing the payload of highly toxic ADC with a deactivator can improve safety and effectiveness;2) Antibody targeting makes DAC more selective than traditional degraders。
Otsuka Pharmaceutical announced a partnership with genetic technology company ShapeTX to provide innovative treatments for patients with eye diseases
9Otsuka Pharmaceuticals announced a multi-target collaboration with Shape Therapeutics in a potential transaction of up to $15, with financial details not disclosed。
Under the agreement, Otsuka will apply Shape's AAVidThe protein capsid discovery platform and the RNA editing platform RNAfix are jointly developing AAV gene therapy in ophthalmology。
Shape的AAVidThe protein capsid discovery platform is powered by AI to screen AVV capsids with high target accuracy and minimal off-target biodistribution through high-throughput screening and machine learning, thereby reducing the required dose and associated clinical safety risks。
In addition, Shape will apply RNAfix, an RNA editing platform, to optimize the payloads Otsuka offers to achieve therapeutic levels of gene expression in target cell types。
ShapeFounded in 2018, it has been committed to the development of RNA editing gene therapy, and although it is only a start-up company, it has received multiple rounds of financing。
2021年,Shape获得1.A $1.2 billion Series B funding round and a $3 billion R&D collaboration with Roche to develop next-generation mRNA therapies to prevent and treat multiple complex diseases, including Parkinson's and Alzheimer's。
Otsuka currently has two marketed ophthalmic drugs, Mucosta for dry eye and Mikeluna for glaucoma and ocular hypertension。
Although this collaboration is based on the development of ophthalmic drugs, the core business of both parties is focused on the CNS field。
It is worth mentioning that more than a month ago (July 31) Otsuka announced that two Phase III studies of its anti-schizophrenia candidate Ulotaront failed to meet the primary endpoint。
Pharmed Juno seeks further strategic collaboration with biotechnology company 2SEVENTY BIO
The company announced on the Hong Kong Stock Exchange on September 12 that it intends to expand its strategic alliance with 2seventy bio,Inc。The potential collaboration builds on the company's relationship with 2seventy bio, established in 2022, and builds on the company's translational and clinical cell therapy development platform with 2seventy bio, which was initially aimed at faster development of T cell-based immunotherapy products in Greater China。
Specifically, the company and 2seventy bio intend to jointly develop additional drug candidates from 2seventy bio's portfolio for solid tumor indications using T cell receptor-based technologies and autoimmune diseases using CAR T cell technology pathways。
As of the announcement date, the potential partnership is still under negotiation, and the company and 2seventy bio have not reached a definitive agreement regarding the potential partnership。因此,潜在合作未必能进行。
2 seventy bioIs a cell and gene therapy company engaged in the research, development and commercialization of innovative cancer therapies with the aim of truly disrupting the field of cancer treatment。Its approach combines its expertise in T cell engineering and lentiviral vector gene delivery methods, its experience in cell therapy research, development and production, and a suite of technologies that can be selectively deployed to develop highly innovative next generation targeted cell therapies for cancer patients。2 seventy bio's lead product, ABECMA, is the first CAR T cell therapy approved by the U.S. Food and Drug Administration for the treatment of multiple myeloma。
Radiopharmaceutical company Mariana Oncology received 1.75亿美元超额认购B轮融资
9Today, Mariana Oncology, a U.S. targeted radiopharmaceutical company, announced the completion of 1.75亿美元的超额认购B轮融资。The company will use the funds to advance its lead radionuclide candidate MC-339 and its precision radionuclide therapy。The round was led by Deep Track Capital and Forbion,Existing shareholders Atlas Venture, Access Biotechnology, and RA Capital Management, as well as new investors Eli Lilly, Nextech Invest, and Surveyor Capital, followed。
Mariana Oncology成立于2021年,It is a biotechnology company incubated by three well-known life science Venture Capital firms, Atlas Venture, RA Capital Management and AccessBiotechnology,The three institutions also participated in Mariana's $75 million Series A funding round。
Simon ReadHe is the founder, Chief Executive Officer, President and a member of the Board of Directors of the company。Prior to founding Mariana Oncology, he was an entrepreneur-in-residence at Atlas Venture。
SimonHe served as Chief Strategy Officer of Ra Pharma until its acquisition by UCB Pharma。
SimonOver 25 years of research and development experience, including leadership roles at GlaxoSmithKline, Astrazeneca and Roche/Genentech, working on the clinical development of some of the industry's most widely used drugs, including Rituxan (Rituximab) and Actemra (tolumab).。
He is also a co-founder and board member of molecular gum start-up Triana Biomedicines, a member of the Scientific Advisory Board of Q32 Bio and a member of the British Medical Association。
He received his PhD from the University of Hertfordshire, studied physiology at the University of Manchester, and has authored more than 50 peer-reviewed articles and patents。
Alonso Ricardo担任Mariana的首席科学官。Previously, he was an entrepreneur in residence at RA Capital Management。
Like Simon, Alonso also worked at Ra Pharma, where he held the position of Chief Technology and Innovation Officer。
During this time, he led the discovery and early development of several experimental drugs, including Zilucoplan, an immunomodulatory peptide currently being evaluated in multiple Phase 2/3 trials, and MK-0616, a peptide of the same class that targets PCSK9 orally.。
AlonsoWith more than a decade of experience in drug discovery and development, he has led scientific programs across multiple therapeutic programs in immunology, metabolic diseases, and oncology。
In addition, Dr. Alonso was a professor at the University of Los Andes in Bogota, Colombia, and an investigator at the Howard Hughes Medical Institute at Harvard University。
Bernard LambertI'm the CTO of Mariana Oncology。He previously served as President and Chief Operating Officer of Telix Pharmaceuticals' U.S. operations。
During this time, he led regulatory and commercial operations for clinical stage and marketed products for kidney, prostate, and brain cancers, and led the U.S. team that obtained FDA approval for the prostate imaging radiopharmaceutical Illuccix。
He served as Vice President of CMC and radiopharmaceutical Development for Zevacor Pharma, Zevacor Molecular and IBA Molecular。
BernardHe has more than 20 years of experience in all stages of small molecule and antibody-based radiopharmaceutical development。
Sandy MongHe is the company's Senior Vice President of Business Development and Operations。Prior to joining Mariana, she was entrepreneur-in-residence at Atlas Venture。
SandyPreviously, he was Vice President of Business Development and Operations at BridgeBio Pharma, where he focused on the development operations of single-asset subsidiaries and supported model-independent asset acquisitions and platform partnerships。
Mariana Oncology currently has 50 employees。
Mariana OncologyIs a fully integrated next generation radiopharmaceutical company focused on the development of novel targeted peptide radiopharmaceuticals。
The company's radiopharmaceuticals consist of conjugates reasonably designed against biological targets to provide payloads that emit alpha or beta radionuclides。By designing molecules that penetrate solid tumors better than antibodies and deliver optimized doses of high radio-activity without the side effects associated with chemotherapy and toxin-based strategies。
Mariana OncologyLigand patterns are paired with target characteristics driven by tumor target biology。Ligands are designed to achieve deeper, more uniform tumor distribution as well as rapid systemic clearance to achieve drug properties not yet achieved with existing approaches。
Drug discovery based on macrocyclic peptides is key to Mariana Oncology's strategy for targeting targets with well-defined extracellular domains。
In other high-value targets whose structures are less defined or fall off, Mariana Oncology is employing proprietary peptide and non-peptide approaches。
In addition to ligand discovery, Mariana Oncology's in-house radiochemistry and radiobiology teams build performance-balanced radiopharmaceuticals from scratch using alpha and beta radionuclide payloads。
Mariana OncologyLigand design criteria include potency, selectivity, stability, physicochemical multi-parameter optimization, avoidance of drug efflux/uptake of transporters, and addition of ligand and chelate chemistry for radioactive payloads。
The company balances these factors by leveraging R&D expertise and flexibility in peptide and non-peptide small molecule drug discovery。
In Mariana Oncology's view, there is no single ligand discovery platform that is suitable for all high-value tumor targets。
Key aspects of target biology define the choice of the most appropriate approach, such as the presence or absence of structured extracellular domains, whether the target is internalized and at what rate, and whether this is necessary to deliver the therapeutic payload to the cell。
In addition, other targets actively enter the circulation, leaving short "truncated lines" of near-membrane peptides, so obtaining ligands with high affinity and selectivity can be challenging。
In response, the Mariana Oncology research and development team applied its expertise to a range of ligand platforms to select the best fit for the target。
At present, the company's core pipeline MC-339 is a peptide small molecule that can be modified to carry the "actinium" payload for the targeted radiopharmaceutic therapy of small cell lung cancer, and is expected to begin human testing next year。
Small cell lung cancer is a rare, aggressive form of lung cancer characterized by rapid tumor progression, low patient survival, and limited treatment options。In 2020, small cell lung cancer will account for about 10-15% of the estimated 2.2 million new cases of lung cancer worldwide。MC-339的靶点尚未披露。
Although MC-339 is still in the preclinical stage, the company's shareholders are satisfied with the drug。
ForbionManaging partner Geert-Jan Mulder, MD, said: "MC-339 has the potential to transform the treatment of small cell lung cancer by taking advantage of the peptides' enhanced tumor distribution to target the delivery of actinium payloads。”
This is also the first investment by Forbion Ventures Fund VI。
1.75The high financing amount of $100 million, combined with the support of a strong consortium of new and existing investors, is enough to demonstrate the potential of Mariana Oncology。
"Just 18 months since our Series A funding round, we are leveraging our deep expertise in peptide discovery and radiochemistry to advance a diversified portfolio of novel molecules," said Simon Read, Ph.D., founder。
Deep Track CapitalRebecca Luse, Principal of Mariana Oncology, said, "Mariana Oncology's pipeline is innovative and different from most existing radiopharmaceutical companies。We are interested in broader opportunities for radiopharmaceuticals beyond prostate cancer。”
In conjunction with the financing, Rebecca Luse from Deep Track Capital and Geert-Jan Mulder, MD from Forbion, will join the board of directors。
Apollo Therapeutics完成2.265亿美元C轮融资
9Apollo Therapeutics, a portfolio biopharmaceutical company focused on transforming basic medical research into drugs through a hub-and-spoke approach, announced the completion of 2.$26.5 billion Series C funding round led by Patient Square Capital, M&New investors such as G plc and existing investor Rock Springs Capital are involved。
The company intends to use these funds to advance pipeline projects through clinical development and further fund its drug discovery and development activities based on breakthroughs in basic medical research achieved by its partner institutions, as well as licensing or obtaining additional clinical phases of programs that meet stringent selection criteria。
Apollo TherapeuticsLed by CEO Dr. Richard Mason, the company is a biopharmaceutical company focused on translating basic medical research into medicines。The portfolio model is built around a centralized management team of capital allocators and functional leaders with expertise in pharmaceutical research and development, manufacturing, business strategy, financing, and business development, and draws on a diverse portfolio of therapeutic projects, each led by a dedicated leader。资产领导者。资产存放在独立的全资子公司中。
Current partners are: University of Cambridge, Imperial College London, University College London, King's College London and the Institute of Cancer Research。
ApolloIt has operations in Cambridge, UK, and Boston and Chicago, USA。
Nimbus Therapeutics宣布完成2.1亿美元私募融资
9Nimbus Therapeutics, a company that designs and develops breakthrough drugs in the clinical phase through a powerful computational drug discovery engine, announced the completion of 2.$100 million in funding to advance the next wave of small molecule drug development based on its proprietary technology platform。
The round was led by new investor GV(Google Ventures) and existing investors SR One and Atlas Venture,Existing investors, including Gates Frontier, Pfizer Ventures and RA Capital Management, and another new fund are participating。
NimbusClinical development of NDI-101150, an HPK1 inhibitor for patients with solid tumors, will continue。In addition, the new funding will drive several preclinical programs into and through early-stage clinical development, including programs targeting WRN(Werner syndrome helicase) and an undisclosed autoimmune disease target。Nimbus is also working with Eli Lilly to develop new targeted therapies to treat a potentially wide range of metabolic disorders by activating AMPK。
NimbusFounded in 2009 and headquartered in Boston, Massachusetts, the company focuses on structure-based development of small molecule drugs that target difficult drug targets。The company's previous financing performance has been very bright, has raised nearly $700 million, and has completed new financing in each of the past four years, and has not been affected by the capital winter。
ROME TherapeuticsCompleted an oversubscribed $72 million Series B financing round
9ROME Therapeutics, a biotechnology company, announced the completion of an oversubscribed $72 million Series B expansion round, bringing its total Series B funding to $1.49亿美元。The financing expands ROME's investment banking syndicate, with new investors including Johnson & Johnson Innovation-JJDC, Bristol-Myers Squibb, Eurofarma Ventures, Luma Group, Mirae Asset Capital, and family offices Raycap and Sigmas Group。现有投资者ARCH Ventures、GV、Section 32、Sanofi Ventures、Andreessen Horowitz、Mass General Brigham Ventures、Casdin Capital和Alexandria Venture Investments也参与了本轮投资。ROME plans to use the funds raised from the Series B extension to advance early-stage clinical trials of its drug candidate, a LINE-1 reverse transcriptase (RT) inhibitor, including a Phase 1 study to evaluate safety and determine the optimal dose, as well as other studies aimed at demonstrating its mechanism。ROME plans to develop drug candidates for a range of serious autoimmune diseases, including lupus in which LINE-1 is abnormally expressed。ROME also plans to continue advancing its early product line and proprietary data science platform, which enables the company to identify functionally active repeating elements and assess their role in disease。
China's retail drugstore chain rate continues to improve, drugstore giants to expand the scale of expansion
With the trend of economic development and aging, the public's demand for health services is increasing, and the recent report of Guohai Securities shows that the number of pharmacies in China is expanding steadily, with a growth rate of more than 5% since 2018, to reach 62 retail pharmacies in 2022.3万家。However, at the same time, the chain rate of national pharmacies is also rapidly improving, and the national chain rate of pharmacies will reach 57 in 2022.It is predicted that this figure will be close to 70% by 2025。While the chain rate is rapidly improving, for a large part of single pharmacies, they are still facing structural competition pressure from the market。
Compared with chain pharmacies, there are three difficulties in the operation of single pharmacies: from the perspective of suppliers,单体药店的采购规模有限,Therefore, the bargaining power of upstream suppliers is weak;From the perspective of internal management,The management tools and modes of individual pharmacies are difficult to produce marginal utility,Relatively high unit management cost;From the perspective of brand building,单体药店难以借助规模效应,Continue to produce brand influence on downstream consumers and widely establish brand image。
At the same time, branded drug companies are also looking for more possibilities。According to CMH data, from 2015 to 2022, the overall sales scale of retail pharmacies in China maintained steady growth, and the sales scale in 2022 reached 542.1 billion yuan, of which the proportion of drug sales in physical pharmacies increased significantly。Therefore, the current proportion of nearly half of the monomer pharmacies, still look forward to cooperation with brand drug companies。Under this trend, retail drugstore giants such as Dingdang Fast Medicine, Dashan Lin, and Jianzhijia have accelerated the chain layout to attract single pharmacies to join。
The chain rate of pharmacies increased year by year, and the loss of single pharmacies accelerated
According to the "Annual Data of Drug Supervision and Administration Statistics (2022)" released by the State Food and Drug Administration, by the end of 2022, there were 64 "Drug distribution License" certified enterprises in the country.4万家。其中,批发企业1.4万家,零售连锁总部0.67万家,零售连锁门店36.0万家,单体药店26.3万家。
Market situation and competitive landscape of retail pharmacy industry,叮当快药千城万店负责人冯钢介绍,截至2022年12月底,全国共有64万家终端药店,在过去的十年中,中国药店数量增长了20多万家,由42万家增加到64万家,This speed has made the entire pharmacy industry more competitive,市场总体规模增长1000多亿,但药店数量也增长三分之一。
According to Soochow Securities Research Report, the number of chain pharmacies in China has expanded, driving the chain rate to show an increasing trend。The number of chain pharmacies increased from 22 in 2017.9万家提升至2022年的36.0万家,5年CAGR为9.47%。The development of the total number of pharmacies in the past 10 years is mainly driven by the development of chain pharmacies. In 2017, the number of chain pharmacies exceeded the number of single pharmacies, and so far, the number of chain pharmacies is 9 percent higher than that of single pharmacies in 2022.7万家,连锁率达58%。
Feng Gang pointed out that the head chain is more concentrated, and the top 10 account for 30 percent of the market share.91%, benefiting from the advantages of supply chain, informatization, specialization, standardization, etc., driven by new models and new technologies, sales growth is higher than the industry level, but the expansion speed is stable compared with the previous five years。At the same time, the number of small and medium-sized chain and single pharmacies that currently account for nearly 50% of the market share exceeds 480,000, and these stores have relatively low risk resistance, relatively weak in brand effect, bargaining power, and commodity allocation ability, and generally have certain anxiety about the future, and their development prospects are confused。
At the same time, with the impact of the epidemic and other factors, Feng Gang also pointed out that the consumer group from 2000 to 2023 has undergone tremendous changes, through the O2O operation model, consumers' purchasing habits have fundamentally changed, and more and more consumers choose to complete the whole process of consulting and purchasing drugs online。
"The growth rate of online pharmacies is very fast, and the market share has gone from 1.2%增长到2022年近30%。In the first half of 2023, the total sales of retail pharmacies increased by 13%, and the drugstore O2O market grew by 46% in May 2023。The change in consumer buying habits and the growth in online sales has been astounding。This trend has made more and more industry participants pay attention to online operation, and more and more pharmacies have begun to pay attention to online operation needs。”冯钢分析称。
In the overall Chinese pharmaceutical retail industry, Feng Gang pointed out that there is an anxiety pyramid structure, the spire is the top 10 enterprises, its entry threshold is usually more than 2000 stores, relatively superior position, because of the capital, technology and resources, the top 10 enterprises can maintain a rapid growth trend。In 2022, the market share of the top 10 enterprises has reached 30.9%,而2021年时为27.5%。
相比之下,失去市场份额的是25.70,000 monomer pharmacies, Feng Gang introduced, monomer pharmacies accounted for 37 percent from 2021.28%下降至2022年的33.32%, the loss of single pharmacies is very fast and large, and it is still struggling to maintain its position。
As for the anxiety faced by single pharmacies, Feng Gang believes that the anxiety first comes from the supply chain, the traditional product planning can no longer meet the existing consumer demand, the lack of professional online product experience and data, resulting in single pharmacies do not know how to purchase appropriate products to meet consumer demand。Secondly, the drug purchase price is too high, the homogenization phenomenon is serious, and the head chain drugstores can not compete in price, even if the sales at the same price, the profit margin is far less than the head chain drugstores, it is difficult to support online and offline operating costs。
"Another anxiety is the lack of professional operation capabilities, single pharmacies often have neither a suitable team, nor a complete management system, lack standardized offline member management, and want to meet the online development but lack of relevant experience.。Our partners have two main anxieties: they can't buy and they can't sell。”冯钢表示。
For the current monomer pharmacy in the market competition facing anxiety,冯钢表示,Dang Dang fast medicine in the promotion of thousands of city million store alliance strategy,Attract individual pharmacies to join the Dingding Smart Pharmacy alliance,To "one-stop digital intelligence omni-channel solution" to solve the above anxiety of single pharmacies,Including drug supply chain, digital infrastructure, platform services, operation empowerment four directions。
At the level of drug supply, Dingdang Fast medicine can help pharmacies directly connect with the source factory supply, reduce middlemen, and ensure the stability and reliability of drug supply through the open sharing of Dingdang self-owned drug supply chain platform "Medicine intersection"。At the level of digital infrastructure, Dingdang Fast medicine adopts dual systems of POP system and SaaS system in commodity management and member management to support the operation of pharmacy terminals。
At the service level, there is a continuous shortage of pharmacists and doctors in the industry, which brings certain challenges to the service quality and efficiency of terminal pharmacies, especially monomer terminal pharmacies。In this regard, Dingdang Fast medicine to alliance pharmacies to provide Dingdang fast medical consultation platform and Internet hospital platform。Finally, at the level of operation empowerment, Dingdang Fast Medicine provides online and offline omni-channel operation support for alliance pharmacies。On the online channel, Dingdang Fast medicine can provide support for the online operation of the alliance pharmacy, including O2O mode and B2C mode.In the offline scene, Dingdang Fast medicine can provide sales support to the alliance pharmacy through a variety of ways integrating online and offline。
In addition to Dingdang fast medicine, under the current industry development trend, a number of chain pharmacy giants also continue to expand chain。According to the research report of Soochow Securities, in the increasingly fierce competition, the pharmacies have implemented a chain expansion model based on self-establishment + mergers and acquisitions, and joined as a supplement。Six major drugstore chains have announced plans to expand their stores in 2023, with a total of more than 16,200 new drugstores, including about 6,500 self-built and mergers and acquisitions。
Among them, Dachenlin has carried out national expansion through the three-wheel drive method of "self-construction + merger and acquisition + joining"。据头豹研究院介绍,On the one hand, Dachenlin will continue to open new stores, mergers and acquisitions and new expansion franchises,继续下沉已布局区域的二、三线市场,同步开拓重要区域的新市场,Continuously expand the scale of retail channel brands to enhance competitiveness,以继续保持规模优势;另一方面,Dachenlin has also been deepening its development in the wholesale industry,开发药品行业各层级领域的客户,重点分销总代理与自有品牌品种,Cooperate with the business of circulating varieties to meet the business needs of customers,The in-depth layout of the large health industry is the main strategy of the management level。
On the other hand, Health Care focuses on operational differentiation and diversification of business formats to help its sustainable development in the retail pharmacy chain market。First of all, Health opened convenience stores, traditional Chinese medicine clinics, community clinics, physical examination centers and other store types, and gradually explored the model of "pharmacy + convenience store" and "pharmacy + clinic"。
At the same time, Jianzhijia insists on building its own team to carry out online business operations, learn from each other and complement each other's advantages. The commodity power, service power and professional strength of offline physical stores have become a strong backing for online business, and online channels such as Jiae-shopping and O2O have empowered store services, and omni-channel services have developed rapidly。In addition, Jianzhijia also continuously improves the talent echelon construction and talent structured training system, aiming to establish a management team with clear responsibilities and rich management experience。

How to deal with the adjustment of the industry cycle in the rapid development of Chinese biomedicine?
Benefiting from the reform of pharmaceutical administration, the innovation capacity of China's biomedical enterprises has continued to increase, and the innovation achievements have continued to land, which has also made the investment and financing in the biomedical field rapidly heating up。
Recently, the State Food and Drug Administration issued the "2022 Annual Drug Review Report" pointing out that the annual review recommended the approval of 21 innovative drugs, including 3 First-in-Class new drugs;The overall completion rate in accordance with the review time limit increased to 99 throughout the year.80%,And a number of categories of time-bound settlement rate achieved historic breakthroughs;The recombinant novel coronavirus protein vaccine (CHO cells) and four novel coronavirus treatment drugs were approved for marketing,38 applications for the registration of symptomatic drugs for the treatment of febrile and cough novel coronavirus infection were approved for emergency review;The number of approved drugs for children is 66,创历史新高……
CytivaZhou Mintao, president of China, also recently told the 21st Century Business Herald that the biomedical industry is a high-speed development industry in the world, and it is also in China。The Chinese market as a whole has witnessed explosive growth in the past six to seven years, with the total market value of Chinese Biotech growing from $1 billion in 2016 to $180 billion in 2021。
However, in 2023, when the economy began to gradually pick up, although the pharmaceutical industry has many bright spots of development, it still outperforms the market as a whole and is in a difficult downward cycle of the industry。Zhan Xiaojing, vice president of global drug safety of Junshi Biology, said at the 12th Medidata NEXT China Annual meeting that although China's pharmaceutical innovation has entered the harvest period, it is still a long way to go global。
据Pharmaprojects®2023According to data from April, there are currently 5,402 drug pipelines in China, accounting for 23 percent of the world's pipelines.6%, an increase of 23 percent over the number of pipelines in 2022.22%,远超全球管线5.89%的增长。In recent years, China's innovative drug research and development strength has increased, the number of IND has increased significantly, and the number of new drugs to sea has also risen。The gap between China and the United States in the number of core clinical applications for new drugs has gradually narrowed, showing that China's innovative drug research and development ability has gradually increased in recent years。
However, at the same time, it can be found that the direction of new drug research and development in China is still focused on fully validated mature targets, and the exploration of emerging targets needs to be improved。At the same time, the proportion of mature targets in China's research targets is much higher than that of the United States and the global average, and 70% of the emerging targets in the world still have no domestic products to enter the clinical stage。
"The target concentration of products in research is high, and the homogenization phenomenon is serious, which also means that enterprises are facing fierce market competition.。It is also under the pressure of price and product "double volume";Under the trend of "double reporting" between China and the United States, the R&D capabilities of increasingly mature local pharmaceutical companies need to be improved;Overseas market potential to be tapped;Driven by multiple factors such as talents and regulatory systems that need to be in line with international standards, it is imperative for local enterprises to actively explore the path of global development。”詹骁靖说。
The report released by Chi Tong Consulting pointed out that at present, the innovation capacity of China's local pharmaceutical companies is still insufficient, and it is necessary to move from "improvement innovation" to "original innovation".。On the one hand, China's innovative drugs can be regarded as a true sense of the world's First-in-Class drugs are still insufficient。So far, FIC new drugs developed by Chinese enterprises have not been fast followed by other domestic and foreign enterprises。Chinese FIC is not successful, the drug is not recognized is only the appearance, the essential reason is that the new target or mechanism behind the drug has not been widely recognized by the industry and academia at home and abroad。
On the other hand, China's pharmaceutical companies are still the most commonly used Fast-follow method, and new drug research and development mostly belongs to Me-too or better Me-Better。Most of China's biopharmaceutical companies are doing generic drug research, which is far from the goal of real innovative large pharmaceutical companies。Among the 11,820 pharmaceutical companies in China, there are only 2,851 companies, or about 24, with new drug research and development projects accounting for more than 50%.1%;而美国这一比例高达99.6%。
In the direction of research and development, the targets of innovative drug research and development are too concentrated, and the homogenization competition is serious。根据CDE数据,The top 10 targets for registered clinical trials in 2021 are PD-1, PD-L1, VEGFR, HER2, etc,The number of varieties is up to 71, 59, 46, 43 respectively (the "acceptance number" field does not repeat the count),More than 90% of drug indications for five of these targets (PD-1, PD-L1, HER2, EGFR, and CD3) are concentrated in the anti-tumor area,Drug indications for the four targets (PD-1, PD-L1, HER2, and EGFR) are all concentrated in the anti-tumor field。
In the view of Zhitong Consulting, the current concentration of hot targets invested and pursued by domestic pharmaceutical companies has resulted in a decrease in the utilization efficiency of medical resources caused by excessively concentrated research and development of limited targets, and even difficulties in patient recruitment, thus affecting the progress of research and development。At the same time, due to the high degree of homogeneity of the pipeline of innovative drug companies in the future, it will also lead to the situation of peer bidding in the later stage of medical insurance collection or national negotiation, if the research and development progress can not take the lead, it will lose the best opportunity to seize market share, and be passive in drug pricing and sales。
In addition, the current changes in overseas approval policies have changed the way the original new drugs are approved, and higher requirements for research and development investment have led to frustration at sea。Of the 3,320 drug clinical trials published on the CDE in 2022, 285 were international multi-center trials, accounting for 8.6%。At present, the clinical trials carried out by Chinese pharmaceutical companies in the United States are still mainly phase I。自2013年至今,Chinese pharmaceutical companies have conducted 659 clinical trials in the United States,其中I期290项(约44%),I/II期118项(约18%),II期130项(约20%),II/III期共17项(3%),III期104项(约16%)。
FDAThe tightening of the new drug evaluation system has also put forward higher requirements for clinical trials of local pharmaceutical companies。詹骁靖指出,There are four main reasons for the rejection of drug marketing applications in the past two years: the clinical benefit is not clear,Insufficient effectiveness (46%);Security data in doubt,Drug toxicity intolerance (12%);Lack of international multi-regional clinical trials (MRCT),15%);Problems with drug production records and facilities (27%)。
2022Many of China's leading innovative drug companies suffered setbacks in the "sea" of tumor drugs,It is also believed to have a lot to do with the FDA's proposed project optimus plan, which requires more dose exploration and dose optimization, and the project diversities guidelines, which require drug companies to include as many people as possible in clinical trials,This is bound to greatly increase the cost of clinical research for pharmaceutical companies。
Since last year, the innovative drugs of Xinda Biology, Junshi Biology, and Hutchison Pharmaceutical have suffered setbacks when applying for listing overseas;In February this year, the overseas authorization of obitinib, a BTK inhibitor of Noroshing Jianhua, was returned by Bojian, and the "sea" of innovative drugs was once again cast a shadow。How to solve the above series of problems has become an important issue of concern in the industry。
In the view of the industry, the root cause of a series of problems facing local innovative pharmaceutical companies is that many market capital is more willing to invest in products with clear targets and can be quickly listed, resulting in China's basic research strength is still weak。The more faced with such an environment, it is also necessary to force innovative drug companies to avoid homogeneous competition, strive to move towards the stage of "original innovation", strengthen the research and development of "First-in-class" innovative drugs, and pay attention to the research and development of important varieties that do not meet the requirements。
Li Jin, director of the Department of Cancer Medicine of Oriental Hospital Affiliated to Tongji University, president of Shanghai Artemon Hospital and chairman of Oriental Clinical Cancer Research Center, mentioned at the above forum that the biopharmaceutical industry is an important pillar of China's economic construction and is closely related to the future development of China。Since 2014, the number of biopharmaceutical enterprises in China has increased significantly, and close cooperation between all parties has continuously promoted the innovation and development of the biopharmaceutical industry。
加强产学研医多方合作是重要趋势。Zhou Mintao introduced the recently revised "Shanghai Pilot Program for the import of biomedical research and Development Articles" 2.As an example, the 0 version of the policy is mainly adjusted and improved for the management policy of imported biomedical research and development items。The implementation of the program will help promote the development of the biopharmaceutical industry in Shanghai and promote cooperation and exchanges between domestic and foreign biopharmaceutical research and development institutions and enterprises。
"The implementation of this program will provide Cytiva with more convenient conditions and more opportunities to accelerate the development of technology applications.。At the same time, the plan will also encourage enterprises to strengthen cooperation with domestic research and development institutions and universities to promote the development of domestic research and development needs, the policy will largely facilitate imports, and will help promote biopharmaceutical research and development and extensive cooperation between enterprises。We also hope to carry out more cooperation with more Chinese enterprises。”周敏涛说。
In addition to multi-party cooperation, digital technology is also needed。"Digitalization is a historical inevitability, from eDISC (Intelligent Clinical Research Collaborative system) to EDC (electronic data acquisition system), data interconnection has the characteristics of more secure data, higher efficiency and higher accuracy, which will bring multidimensional improvement to the level of early tumor clinical research.。With a global industry-leading clinical data acquisition and management system, Rave EDC has conducted more than 30,000 clinical studies worldwide, enrolling more than 9 million patients。Li Jin said that Rave EDC, as the preferred EDC solution for clinical trials, is first applied to phase I trials of anti-tumor drugs to optimize data management, help comprehensively improve the efficiency of trial data collection, and enhance the quality and integrity of trial data。
Data acquisition is the first step in digitization and also a solid foundation。"Tall buildings start from the ground, and today, we are also pleased to see the clinical trial industry dare to try and actively try in the application of innovative digital technology.。比如AI。When I arrived at Dongfang Hospital five or six years ago, I realized that we might need to use artificial intelligence。”李进强调,一方面,这是历史的必然,现如今,Artificial intelligence is already in full swing in many industries around the world;On the other hand,随着药物临床试验中心迅猛发展,临床研究也比较多,Doctors work from seven o 'clock in the morning until after nine at night,工作压力非常大。How to reduce the burden of doctors and at the same time to complete the research task?就是要借助人工智能。
"We also hope that the intelligent platform, by integrating intelligent recruitment, clinical trial data management, sample management, data center, etc., can rely on artificial intelligence to input and analyze data, freeing doctors and nurses, especially CRC (Clinical Coordination Researcher)."。”李进说。
CytivaThe Global Biopharmaceutical Resilience Index, conducted in 2023, also found that benefits from digital infrastructure and industrial4.83% of Chinese biopharmaceutical executives surveyed believe that China is equally or very efficient in using advanced digital technologies。
In addition to clinical trials and research and development layout, the problem of commercialization and internationalization "going to sea" has always been the most focused topic。At present, many Biotech companies believe that "going to sea" internationalization can strengthen the hematopoietic function of local innovative pharmaceutical companies。There are also different views that "going to sea" is not suitable for all Biotech companies。
Compared with previous years, it can be found that the overall progress of domestic innovative drugs "going to sea" has slowed down recently。不少企业也愈发认识到,想要实现产品的顺利“出海”,一方面,There is a real clinical unmet need to be tapped,Develop truly differentiated competitive advantage products,避免被卷入同质化竞争;另一方面,需要做好临床前和临床研究,加快海外临床,靠科学数据说话,提高产品成功商业化的可能性。
究竟该如何实现?对此,Li Wei, vice president of Dassault Systemes' life sciences division and general manager of Medidata Greater China, told 21st Century Business Herald,近几年,We have also witnessed the success of domestic innovative drugs in overseas markets,Supported innovative drug research and development of all 23 large license out in China,其中大额指的是5亿美元以上的交易,几乎涵盖了所有热门和创新的靶点。
"It is also noted in this process that China's innovative drugs are the dream of several generations of clinical research practitioners, China's pharmaceutical research and innovation is rapidly in the process of international integration, and hope to go to the front end in some areas, but the global ranking of this innovation, Chinese pharmaceutical companies have not entered the top 50 queue.。Li Wei said that an important part of the so-called "going to sea" is to follow international prevailing regulations, such as ICH (International Technical Coordination Committee for Human Drug Registration).。China does not have a separate regulation, but its drug management system, especially its registration system, is rapidly moving in line with international standards。
"Some time ago, the new ICH regulations were released, and clinical researchers discussed how to implement the new ICH regulations in China。Therefore, the system is not divided, and local pharmaceutical companies need to better rely on companies with global compliance experience and innovative and mature technology support to help them quickly go international。”李威说。
The same consulting also suggested that enterprises need to re-examine strategic planning, distinguish between passive and active sea, not only because in the domestic encountered more than anyone imagined the industry winter is forced to go to sea, but to have enough innovation and operational capacity after the sea。Although a global presence is the true statement of our strength, the Chinese market is still the foundation of Chinese pharmaceutical companies。
Despite facing the challenges of target clustering, fierce market competition, and continuous bottleneck of "going to sea"。However, many people in the industry believe that biomedical companies are still worthy of attention。"We are still very optimistic about the development prospects of China's biopharmaceutical industry。From this point of view, we are also accelerating and strengthening the strategy of localization。The expansion of the science and Innovation center is actually a major measure in the localization strategy, the function of the science and innovation center is also to promote the entire ecosystem, the biggest role is to empower the industry, targeted to solve the current needs of China's biopharmaceutical industry in new therapies, intelligent manufacturing and talent training。而不是为了创造营收。Zhou Mintao pointed out that after experiencing explosive development in the past few years, the biomedical industry has now entered a period of adjustment, which is good for the industry。It is also at this stage that high-quality and efficient development should be promoted。
"Market changes have prompted many immature capital and low-quality enterprises to leave, which is not a bad thing for the development of the industry.。The biomedical industry is a long-term industry, and we believe that in the future, this industry will be good for a long time。”周敏涛强调。

AIWith the support of domestic and foreign pharmaceutical companies are accelerating the exploration of pharmaceutical frontier fields
In recent years, in order to develop innovative drugs more quickly, efficiently and with low consumption, more and more pharmaceutical companies are actively cooperating with AI pharmaceutical companies and AI platforms to jointly promote the sustainable innovation and development of drug target discovery, rational drug design, drug reuse and other research fields。
9月12日,Biotechnology companies Exelixis and Insi Intelligence jointly announced,双方已签署一项独家许可协议,Exelixis will acquire global development and commercialization rights for ISM3091 from InSI,ISM3091 is a potential best-in-class small molecule inhibitor,Synthetic lethal target USP1 targeting BRCA-mutated tumors。
Under the terms of the agreement, InSI will grant Exelixis an exclusive worldwide license to develop and commercialize ISM3091 and other USP1 targeting compounds, with an upfront payment of $80 million in the third quarter of 2023。In addition, InSI is eligible to receive milestone payments based on subsequent development, commercialization and sales, as well as tiered royalties on future product net sales。
The industry believes that the conclusion of this cooperation marks the continuous innovation and cooperation in the field of artificial intelligence and biotechnology, and provides new opportunities and prospects for research and development in the field of cancer treatment。In the future, it is also expected to lead to more innovative treatment options for patients with BRCA mutated tumors。
Public information shows that InsiliconIntelligence is a biomedical technology company driven by generative artificial intelligence。In recent years, it has reached new drug development cooperation with many pharmaceutical companies。Now in August, InSI Intelligence just announced that the candidate drug ISM8207 developed in cooperation with Fosun Pharmaceutical for the treatment of advanced malignant tumors has obtained the clinical trial implied license of the State Drug Administration (SDA), and intends to carry out phase I clinical trial research in China after the conditions are met。It is reported that this is the first clinical milestone achieved since InSI Intelligence and Fosun Pharmaceutical reached a strategic cooperation。
In fact, the application of AI technology in the pharmaceutical field has become a very important trend that is shaping the development of the entire pharmaceutical and biotechnology industry。In addition to InSI Intelligence, Jingtai Technology has also been cooperating with domestic and foreign pharma and Biotech companies in new drug discovery this year, and has used AI algorithms to drive multiple anti-cancer drug research and development projects and AI enabling process optimization projects。
For example, on September 4, Jingtai Technology announced a cooperation with Parthenon Therapeutics, which focuses on the reconstruction of tumor microenvironment, to jointly develop antibody drugs against solid tumors。On May 31, Jingtai Technology announced that it signed an AI small molecule new drug discovery cooperation agreement with Eli Lilly, and the advance payment and milestone total revenue can reach 2.5亿美元。
In summary, in the context of the continuous integration of AI and the pharmaceutical industry, many pharmaceutical companies are accelerating to explore frontier areas that have not yet been set foot in the world, such as small molecule crystal structure prediction and primary drug design。It is reported that in China, AI drug research and development has made many breakthroughs in 2022。As of 2022, 14 of the 80 Chinese AI drug companies have successfully promoted the pipeline to the clinical stage, most of which are in the clinical phase I stage。Among them, the first fully AI-based pipeline ISM001-005 entered clinical phase I and completed the first batch of healthy subjects。
In the future, the industry expects that with the support of AI, domestic pharmaceutical companies will also process and analyze a large amount of biochemical information more quickly, and screen out suitable compounds, design and optimize the molecular structure of drugs, and achieve cost reduction and efficiency at the same time, the competitiveness of domestic pharmaceutical companies will continue to improve。

A world first!East China Medicine GLP-1R/GCGR/FGF21R triple agonist was approved as a new clinical agent
9On October 8, the CDE official website showed that DR10624 for injection from Zhejiang Dowell Biotechnology Co., LTD. (a subsidiary of East China Medicine) received an implied approval for clinical trials and is intended to be used in the treatment of type 2 diabetes。
据了解,DR10624 is the world's first (first-in-class) GLP-1R/GCGR/FGF21R long-acting triple agonist,Previous clinical trials for weight management in overweight or obese people have been approved by CDE,Type 2 diabetes is the second indication for which the drug has been approved for clinical trials in China。
自减重“神效”爆火,GLP-1 has become one of the hottest targets in the field of drug research,The development of related drugs has also rolled from single target agonists to multiple agonists,Such as Lilly's LY3437943, civilian biological MWN-101, and federal pharmaceutical recently approved clinical UBT251,All three drugs are GLP-1R/GIPR/GCGR triple agonists。In June this year, Lilly presented relevant data at the 83rd Annual Scientific session of the American Diabetes Association, showing that three-target drugs may show more robust efficacy than dual-target drugs。
DR10624It is also a GLP-1 triple agonist, slightly different from the above three drugs in that its targets are GLP-1R, GCGR, and FGF21R。According to the previous announcement of East China Medicine, DR10624 is a symmetrical dimer in structure, and can be fused with IgG1Fc with deglycosylation modification to extend the half-life while having the biological activity of GLP-1R, GCGR and FGF21R as a triple agonist。
In China, in addition to obesity and diabetes, East China Medicine has also submitted DR10624 IND for severe hypertriglyceridemia (htg) in August this year。In addition, the Phase I multiple incremental dose administration clinical trial of DR10624 for obesity completed its first subject administration in New Zealand in July。
DR10624It is not only expected to meet the clinical treatment needs of obesity, diabetes and htg, but also has a huge potential market space。
Huadong Pharmaceutical has occupied a leading position in the domestic GLP-1 circuit。
今年3月,华东医药的利鲁平®Became the first domestic Liraglutide injection approved by NMPA。Following this, the obesity or overweight indication also received marketing authorization from NMPA in early July, Lirupine®It is also the first GLP-1 drug approved for this indication in China。Huadong Medicine also took the lead in challenging the original research patent of Simeiglutide, and its Simeiglutide injection has completed its phase I clinical study and reached the endpoint of equivalence study, and started phase III clinical study work。
In terms of GLP-1 innovative drugs, East China Pharmaceutical pipeline has oral small molecule GLP-1 receptor agonist HDM1002, its diabetes indication has been approved by the Chinese and American double IND, GLP-1R/GIPR polypeptide long-acting double agonist HDM1005 has entered IND research。In addition, SCO-094 and its derivatives, which were introduced by Huadang Medicine from SCOHIA in Japan, are also GLP-1R/GIPR dual-target agonists with Lilly's tilpotide, and have been carried out in phase I clinical trials in the UK。
Morgan Stanley has estimated that the obesity drug market will reach $54 billion in 2030, which is expected to surpass PD-1/PD-L1 to become the largest drug in the world market。Liraglutide injection in hand, Simaglutide rapid progress, a number of innovative drugs clinical acceleration, East China medicine will consolidate the position in the GLP-1 field。
Two Astrazeneca C5 complement inhibitors start Phase 3 trials in China
AstraZeneca (AstraZeneca) has registered and started a Phase 3 international multi-center clinical study of two new drugs in China,Both drugs are the result of its 2020 acquisition of Alexion for about $39 billion,They were: 1) ravulizumab injection, a long-acting C5 complement inhibitor,The indications are: prevention of serious renal adverse events in patients with chronic kidney disease during cardiopulmonary circulation;2) The third-generation C5 complement inhibitor gefurulimab (ALXN1720) injection,针对适应症为全身型重症肌无力。
Publicly available information shows that complement protein C5 is at the end of the complement cascade, so targeting this protein can regulate complement signaling activated by all three different pathways。In a variety of complement-mediated immune diseases, the complement-mediated immune response attacks the patient's own healthy tissues and cells, resulting in damage to different tissues and organs。Inhibiting the activity of the C5 complement can inhibit this immune attack on the body, thereby relieving disease symptoms。
Chronic kidney disease (CKD) is a type of disease in which the structure or function of the kidney is abnormal for more than 3 months and affects the health。Cardiopulmonary bypass is a life-support technique. During cardiopulmonary bypass, CKD patients may experience hypotension, decreased renal blood flow, metabolic acidosis, and vascular reactions, all of which can lead to decreased renal function。
RavulizumabAlexion is a long-acting C5 monoclonal antibody developed by Alexion with a unique design that gives it a longer half-life than first-generation C5 complement inhibitors。In the treatment of patients with paroxysmal sleep hemoglobinuria, it only needs to be administered intravenously once every 8 weeks to effectively control the occurrence of hemolysis。
Public information shows that ravulizumab has been approved by the US FDA for a variety of autoimmune diseases (trade name: Ultomiris), including paroxysmal sleep hemoglobinuria, atypical hemolytic uremic syndrome (aHUS), myasthenia gravis and so on。The drug also achieved positive results in a Phase 3 clinical trial for the treatment of optic neuromyelitis spectrum disease (NMOSD)。
Astrazeneca is initiating a Phase 3, randomized, double-blind, placebo-controlled, multicenter ARTEMIS study in China,The study was designed to evaluate the effectiveness of ravulizumab in preventing cardiac surgery-related acute kidney injury (CSA-AKI) and subsequent serious adverse renal events (MAKE) in patients with chronic kidney disease (CKD)。The study's principal investigator in China is Chunsheng Wang, chief physician at Zhongshan Hospital, Fudan University。
Myasthenia gravis (MG) is a rare chronic autoimmune disease。Immunoglobulin G (IgG) antibodies disrupt communication between nerves and muscles, causing weakness and potentially life-threatening muscle weakness。More than 85% of patients progress to generalized myasthenia gravis within 18 months of onset, which leads to extreme fatigue and difficulty with facial expression, speech, swallowing and movement。
ALXN1720Injectable is a third-generation C5 complement inhibitor, a bi-specific mini-antibody that contains only the heavy chain variable region (VH) of the antibody targeting C5 and the antibody fragment that binds to albumin。This mini antibody has a molecular weight of only 25kD (the usual antibody molecular weight is ~ 150kD), has better permeability, and can extend its half-life by binding to albumin。It is expected to become a once-a-week, self-administered subcutaneous injection therapy, greatly improving patient access to treatment。
Astrazeneca is initiating a phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter study in China to evaluate the safety and efficacy of ALXN1720 in adults with generalized myasthenia gravis。The study's principal investigator in China is Zhao Zhongbo, chief physician at Huashan Hospital, Fudan University。
Kanghua Biorecombinant hexavalent norovirus vaccine is approved for clinical use in the United States
9On the 7th, Kangh Biological (Kangh) issued an announcement that it has received a notice from the US FDA to agree that the company's recombinant hexavalent norovirus vaccine will enter clinical research in the United States。According to the announcement of Kanghua Biology, the recombinant hexavalent norovirus vaccine is suitable for preventing norovirus infection and acute gastroenteritis caused by it。
Norovirus (NoV) is a major cause of acute gastroenteritis in children, the elderly and adults. With high infectivity and rapid transmission, it is easy to cause clusters of outbreaks。Norovirus is also one of the major causes of sporadic cases and outbreaks of acute gastroenteritis worldwide。However, there is currently a lack of approved symptomatic treatment or preventive vaccine products on the global market。
根据康华生物公告,It uses genetic engineering technology to construct based on Virus-Like Particles,Recombinant hexavalent norovirus vaccine of VLPs,涵括六种诺如病毒主要流行基因型,In theory, more than 90% of norovirus infections and the acute gastroenteritis they cause can be prevented。According to the ClinicalTrials website, the company is currently conducting a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to evaluate the safety and immunogenicity of its recombinant norovirus hexavalent vaccine in healthy subjects aged 18-59 years。
Founded in 2004, Kanghua Bio is a biopharmaceutical company engaged in the research and development, production and sales of biological products。The layout of the company's research and development pipeline is based on the construction of a vaccine research and development platform. The existing products include ACYW135 meningococcal polysaccharide vaccine and freeze-dried human rabies vaccine (human diploid cells), in addition to influenza vaccine, rabies vaccine, tuberculosis vaccine and other products are under development。
Lilly initiated the small molecule GLP-1R agonist weight loss indication Phase 2 in China
9月6日,Drug clinical trial information publicity and registration platform official website display,Lilly enrolled a Phase III trial of Orforglipron (LY3502970), an oral small molecule GLP-1R agonist, in patients with type 2 diabetes who are obese or overweight (study code: ATTAIN 2).。
ATTAIN-2This is a randomized, double-blind, placebo-controlled global Phase III study,To evaluate the efficacy and safety of Orforglipron once daily in adults with type 2 diabetes who are obese or overweight,Objective To enroll 1500 adults with type 2 diabetes (HbA1c: 7%-10%) with body mass index (BMI) ≥27kg/m2,These patients had at least one weight-loss failure。According to the published information, the study plans to enroll 110 Chinese patients。
Previously, on August 11, Lilly enrolled Orforglipron in the first Phase III clinical trial in obese or overweight patients with weight-related comorbiditieson the Drug Clinical Trial Information Disclosure and Registry (study code: ATTAIN 1).。
Lilly is now fully engaged in the clinical development of Orforglipron,Multiple Phase III clinical studies of Orforglipron have been initiated,To further investigate the efficacy and safety of treatment for obesity and overweight (ATTAIN series) and type 2 diabetes (ACHIEVE series)。
A Phase III study of Johnson & Johnson's EGFR/c-MET double-antibody combination therapy for second-line treatment of NSCLC was successful
9月6日,强生宣布,EGFR/c-MET double antibody Rybrevant (amivantamab),Positive top-line data from the Phase III MARIPOSA-2 study of Avantuzumab in combination with the third-generation EGFR inhibitor lazertinib and chemotherapy in patients with ocitinib-resistant non-small cell lung cancer (NSCLC)。
MARIPOSA-2Is A randomized, open-label Phase III study designed to evaluate the efficacy of amivantamab+lazertinib+ carboplatin + pemetrexed (LACP, Group A) vs after ocitinib resistance.Efficacy and safety of carboplatin plus pemetrexed (CP, Group B) in patients with locally advanced or metastatic NSCLC with a common EGFR mutation (Exon19 del/Exon21 L858R)。At the same time, the study also set up amivantamab+ carboplatin + pemetrexed group (ACP, group C) to evaluate the therapeutic effect of lazertinib in LACP patients。The primary endpoint was progression-free survival (PFS);Key secondary endpoints included objective response rate (ORR), overall survival (OS), duration of response (DoR), and intracranial PFS。
The data results showed that the MARIPOSA-2 study met A dual primary endpoint, i.e., there was a statistically significant and clinically significant improvement in PFS in both experimental groups (groups A and C) compared to chemotherapy alone (group B)。In terms of safety, consistent with data from previous studies, no new safety signals were observed。Johnson & Johnson plans to present these results, including details of secondary endpoints such as OS, ORR, DoR, and others, at an upcoming scientific congress。
AmivantamabIt is an EGFR/c-MET dual antibody developed by Johnson & Johnson。In May 2021, amivantamab was first approved by the FDA for the treatment of patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations following progression of platinum-based chemotherapy, and is the world's first approved EGFR/c-MET dual antibody。此前,7月17日,Johnson & Johnson announced positive results from the Phase III PAPILLON study of amivantamab in patients with advanced or metastatic NSCLC newly diagnosed with EGFR exon 20 insertion mutations,Met the primary endpoint of PFS (Johnson & Johnson's Phase III study of c-Met/EGFR in first-line treatment of non-small cell lung Cancer met the primary endpoint)。

"K drug" Pabolizumab was approved as a new indication of "pantoma species" in China
9Merck announced that PD-1 inhibitor Palizumab (commonly known as "K drug") has been approved by the National Medical Products Administration for use in adult patients with unresectable or metastatic microsatellite highly unstable type (MSI-H) or mismatch repair gene defect type (dMMR) advanced solid tumors。This is the first indication of the drug approved in China based on a specific biomarker status rather than tumor type。
With the development of molecular biology of tumor, MSI-H/dMMR has become one of the important biomarkers of tumor。MSI-H/dMMR is a tumor biomarker closely related to the development, prognosis and curative effect prediction of a variety of solid tumors, and has a certain family heritability。It exists in a variety of solid tumors, and its incidence varies among different tumor species。Taking gynecoma as an example, MSI-H/dMMR occurs in three major gynecoma, namely cervical cancer, ovarian cancer and endometrial cancer。Among them, endometrial cancer is also one of the cancers with a known high incidence of MSI-H/dMMR, accounting for 20% to 30%。MSI-H/dMMR phenomenon also exists in digestive tract tumors, such as gastric cancer accounted for 15%-20%, colorectal cancer accounted for 12%-15%。Regardless of the type of cancer, most patients in the middle and advanced stages are faced with problems such as lack of treatment options, poor quality of life and poor survival prognosis, and it is urgent to find more treatment means。
Pabolizumab is the world's first approved immunotherapy for advanced solid tumors based on MSI-H/dMMR status。In 2021, Pabolizumab has been approved in China for the first-line treatment of MSI-H/dMMR colorectal cancer。This new indication includes colorectal cancer patients with disease progression after prior treatment with fluorouracil, oxaliplatin, and irinotecan, and other solid tumors with disease progression after prior treatment and no satisfactory alternative treatment options。
9According to the official website of the Food and Drug Administration, Qilu Pharmaceutical's Dotilavir sodium tablets were approved for the market for the treatment of AIDS (H IV infection), which is the first generic drug of Dotilavir sodium tablets approved for the market in China。
dolutegravir,Tivicay is an HIV integrase inhibitor developed by ViiV Healthcare, a division of GlaxoSmithKline (GSK),HIV replication can be blocked by preventing viral DNA from integrating into the genetic material of human immune cells。
Dotilavir sodium tablets were first marketed in the United States in August 2013, in the European Union in January 2014, and entered the Chinese market in December 2015 for the treatment of adults and HIV patients over the age of 12。Dotilavir sodium dispersion tablets will be available in the United States in November 2020 and in the European Union in January 2021 for the treatment of pediatric HIV patients。In June 2023, Dotilavir sodium dispersible tablets were also approved for sale in China。This dispersible tablet disintegrates quickly and evenly in water and can be used in pediatric patients with HIV。Compared with ordinary tablets, dispersible tablets have the characteristics of easy to take, fast absorption, high bioavailability and small adverse reactions。
In terms of market performance, the sales volume of dotilavir in 2022 was 13.81亿英镑。Dotilavir's core patent expires in 2028。
Astrazeneca's new indication for the PD-L1 inhibitor Duvaliumab was filed in China
9The CDE official website shows that Astrazeneca Duvaliumab (Imfinzi) new indication marketing application was accepted。This is the fourth indication for Duvaliumab to be listed in China。
Duvaliumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby blocking tumor immune escape and lifting the suppression of immune response。
At present, Duvaliumab has been marketed in five indications worldwide, covering non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, urothelial carcinoma and biliary tract carcinoma。Two indications for non-small cell lung cancer and small cell lung cancer have been approved in China。In March this year, the marketing application of Duvaliumab in combination with first-line chemotherapy for locally advanced or metastatic biliary tract cancer was accepted by the CDE。
As part of the overall development program, Duvaliumab is currently being explored as a single agent or in combination with other anticancer agents in small cell lung cancer, non-small cell lung cancer, bladder cancer, multiple digestive tract (GI) cancers, ovarian cancer, endometrial cancer and other solid tumors。
According to Astrazeneca's financial report, Duvaliumab sales revenue in the first half of this year was 19.76亿美元,增长57%。
Hengrui Pharmaceutical introduced the new indication of innovative drug Limplicide to be listed
9月7日,林普利塞(因他瑞®The marketing application for the new indication was accepted by the State Drug Administration for the treatment of patients with relapsed and/or refractory peripheral T-cell lymphoma (R/RPTCL)。This is the second indication for Limplicide to be declared for marketing, and it is also the first global product of the same target drug to be declared for relapsed and/or refractory peripheral T-cell lymphoma (R/RPTCL)。
The Class 1 new drug introduced by Limplicide for Hengrui Medicine is a highly selective small-molecule inhibitor targeting PI3Kδ independently developed by the partner Maya Li Pharmaceutical。The new indication is based on a single-arm, multicenter Phase II registration clinical study, CTR20210333, to evaluate the efficacy and safety of Limplicide in the treatment of R/RPTCL。The primary endpoint of the study was the overall response rate (ORR) as assessed by an Independent Data Evaluation Committee (IRC).。Preliminary data show that Limplicide has good efficacy and overall controllable safety in the treatment of R/RPTCL, which is expected to become a new treatment option for more patients with R/RPTCL。该研究结果将于后续公布。
PTCLIt is a kind of malignant tumor derived from different stages of T lymphocytes after the thymus, which is more common in Asian countries, accounting for about 21 percent of all lymphomas.4%, significantly higher than European and American countries (about 10%)。Treatment options for PTCL patients are limited, with low efficacy and short duration of existing treatments, and treatment options for R/RPTCL patients are even more limited, and there is no standard treatment plan at present, and the prognosis is very poor, with 3-year overall survival (OS) < 30%。Therefore, there are still unmet clinical needs in the field of R/RPTCL therapy, and there is an urgent need for efficient and safe therapeutic drugs to open up new prospects for the treatment of patients with R/RPTCL。
Professor Jun Zhu of Peking University Cancer Hospital, the lead investigator of the study, said: "PTCL is a group of highly heterogeneous diseases with many subtypes and poor overall prognosis, especially in patients with refractory recurrence, and R/RPTCL lacks effective salvage treatment。As the principal investigator, it is gratifying to see that Limplicide in patients with R/RPTCL met the preset primary study endpoint。At present, there are no PI3Kδ inhibitors approved globally for R/RPTCL patients, and it is expected that Limplicide can fill the gap in this field。”
A multicenter, single-arm, open-label Phase Ib study of Limplicide in 43 patients with R/RPTCL was previously presented at the 2022 annual meeting of the American Society of Hematology (ASH)。The results of this study [4] showed that with a median follow-up of 17 months, ORR reached 60%, complete response (CR) rate was 35%, and disease control rate (DCR) was 84%, which had good efficacy and safety。Following the positive results of the Phase Ib study, the Phase II study of Limplicide for R/RPTCL was officially initiated in 2021。
林普利塞(因他瑞®It has been approved by the State Drug Administration in November 2022 for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two systemic therapies in the past, and it is also the first innovative drug approved for market in Hengri Pharmaceutical's foreign cooperation products。On January 6, 2023, Professor Ma Jun of Harbin Institute of Hematological Diseases and Cancer and Professor Wu Depei of the First Affiliated Hospital of Soochow University issued the first prescription of Limplicide, marking intarui®It has officially entered clinical application, bringing a new treatment option for R/RFL patients in China。
In the 2023 edition of the CSCO Guidelines for the Diagnosis and Treatment of Lymphoma, Limplicide is positively recommended for second-line, second-line, or subsequent treatment of R/RFL, as well as for the after-line treatment of R/RPTCL。
The acceptance of the marketing application for the treatment of R/RPTCL is another important milestone for the drug, and we look forward to bringing new hope to more lymphoma patients with Limplicide。
Rongchang Biotaitacept's new indication application was accepted for the treatment of rheumatoid arthritis
9On July 7, the marketing application for Rongchang Biologic Injectable Titacept was accepted by the CDE for the treatment of rheumatoid arthritis (RA).。
Taitasep (RC18, trade name: Taitai®) is a novel fusion protein independently developed by Rongchang Biology for the treatment of autoimmune diseases, which is composed of the extracellular domain of human transmembrane activator and calcium regulator and cyclophilin ligand interaction factor (TACI) receptor and the crystalline fragment (Fc) domain of human immunoglobulin G (IgG)。Titacept targets two types of cell signaling molecules critical to B lymphocyte development: B lymphocyte stimulating factors (BLyS) and proliferation-inducing ligands (APRIL) to effectively reduce B-cell-mediated autoimmune diseases。
In August this year, Rongchang Bio announced that it had completed a Phase III study of Taitacept in the treatment of RA patients in China, and obtained relevant data results。This was a randomized, double-blind, placebo-controlled, multicenter Phase III trial involving 479 patients。Full analysis set (FAS) results showed that at week 24, ACR20 response rates were significantly higher in patients receiving titacercep (160mg) combined with methotrexate than in patients receiving methotrexate monotherapy, meeting the primary efficacy endpoint of the trial。
In March 2021, Taitacep received conditional marketing approval in China from the National Medical Products Administration (NMPA) for the treatment of systemic lupus Erythematosus (SLE), and was included in the updated National Medical Insurance Catalogue (NRDL) that year.。The company is currently conducting Phase II or III clinical trials for a variety of other indications for the treatment of autoimmune diseases in an attempt to address a significant unmet or undermet medical need in this therapeutic area。
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by aggressive arthritis。At the beginning of the disease, the joint manifestations are morning stiffness, swelling, pain, etc., and finally the joint deformity can occur, and the normal function of the joint is lost, which seriously affects the quality of life of patients。中国RA的患病率在0.32%~0.36%之间,发病率较高。The current standard treatment is dominated by anti-inflammatory drugs, glucocorticoids, traditional immunosuppressants and TNF-α inhibitors, and there is an unmet clinical need for patients who are ineffective or intolerant to these therapies。
百拓维®(Goserelin microspheres) approved for breast cancer indication in China
Beigene is a global biotechnology company. On September 7, the company and Luye Pharmaceutical Group (Hong Kong Stock Exchange code: 02186) announced that Luye Pharmaceutical's self-developed innovative preparation - Goserelin microspheres for injection (Chinese trademark: Beitovir)®It has been approved by the National Medical Products Administration (NMPA) of China for breast cancer patients in premenopausal and perimenopausal women for whom hormone therapy is available。
自今年6月30日百拓维®Since it was approved for the treatment of prostate cancer in China, Beigene has worked with Luye Pharma to quickly start the overall process of benefiting patients with this product and put it into clinical use at the first time。The approval of this new indication means that Batovir®覆盖的患者群体将进一步扩大。
Breast cancer is the largest malignant tumor threatening the health of women in the world, and it is also a high incidence of cancer in Chinese women。The number of confirmed cases of breast cancer in China has reached 420,000 in 2020,The incidence of breast cancer continues to rise at all ages.meanwhile,The age of onset of breast cancer in China is younger than that in European and American countries,The proportion of premenopausal cancer patients is about 1/2;In addition,与年长乳腺癌患者相比,绝经前乳腺癌患者复发风险高,总体生存较差。
Professor Wang Xiaojia, chief physician of the breast medicine Department of Zhejiang Cancer Hospital and deputy director of the CSCO Breast Cancer Expert Committee, said: "Premenopausal breast cancer patients have fertility protection and breast shape preservation,And the treatment experience, quality of life, psychological care, return to society and other aspects have higher and more personalized needs,Therefore, in the clinical treatment should be multidimensional consideration and give more care。百拓维®The upgraded microsphere dosage form and improved injection method can take into account efficacy, safety and patient experience, provide female patients with higher quality treatment, reduce treatment-related psychological pressure, improve treatment confidence and compliance, and help breast cancer patients overcome psychological barriers and return to normal life as soon as possible。”
百拓维®It is the world's first and currently the only approved Goserelin microsphere preparation. Through innovative microsphere technology, it greatly improves the patient medication experience while ensuring the therapeutic effect and safety。The results of the Phase 3 clinical trial of this product for the treatment of breast cancer show that its clinical efficacy is comparable to that of the control drug, and its safety features are similar to that of the control drug, and it can reduce the incidence and severity of adverse reactions at the injection site。其改良的注射针头直径仅0.8 mm, effectively reduce patients' treatment-related psychological burden, with obvious clinical advantages。
Ms. Yin Min, Chief Commercial Officer of Beigene China, said: "Today's female patients play a diverse role in society, family, workplace and other fields, and they have specific demands in terms of treatment and prognosis, and have higher requirements for quality of life。我们很高兴看到百拓维®Approved for breast cancer indications, but also see a large number of patients unfulfilled needs and clear clinical value of the product, looking forward to it can bring higher quality treatment for Chinese breast cancer patients, help them reduce the physical and mental burden, support them to better return to life。Beigene will also continue to work together with Luye Pharma to provide more patients with faster access to effective, safe and better global medicines。”
Mr. Yang Rongbing, President of Luye Pharmaceutical Group, said: "We are very proud to see that Batovir®New indications are added shortly after commercial launch。The achievement of this milestone reaffirms the company's commitment and determination to serve the clinical needs through the continuous and efficient delivery of innovations。With the clinical advantages of this product in the treatment of prostate cancer and breast cancer, Luye Pharma and Beigene will continue to expand the breadth of commercial cooperation between the two parties, promote the acceleration of the transformation of the social and commercial value of this product, and make continuous efforts to improve the accessibility of drugs for patients。”
此前,百拓维®The first indication was approved by the NMPA on June 30, 2023 for prostate cancer patients requiring androgen castration therapy。The product achieved commercial supply within 19 days after approval, and was put into clinical use in a number of hospitals across the country, quickly benefiting prostate cancer patients in China。
IQVIAData show that the total market value of China's gonadotrophin-releasing hormone (GnRH) agonist products in 2022 is about 9.5 billion yuan, with a compound annual growth rate of 17 percent from 2018 to 2022.7%。Based on the large number of unmet patient needs, it is expected that Batovir®将拥有广阔的市场前景。
The first oral preparation of Fosun Guilin Southern medicine has been approved by the US FDA
Recently, Fosun Pharmaceutical member enterprises Guilin Southern Medicine Co., Ltd. to undertake the production of broad spectrum antimicrobial drug sulfamethoxamide唑甲氧苄啶片800mg/160mgThe specifications were approved by the US FDA and achieved zero breakthrough in the oral preparation production line varieties approved by the FDA。It is of great significance for Guilin Southern Medicine to expand its overseas market and improve its international ability。
磺胺甲Trimethoprim tablet is a sulfanilamide antimicrobial, is sulfamethoxazole (sulfamethoxazole)SMZ) in combination with trimethoprim (TMP),The action mechanism of SMZ is: SMZ acts on dihydrofolate synthetase,干扰合成叶酸的第一步,TMP作用于叶酸合成代谢的第二步,选择性抑制二氢叶酸还原酶的作用,The combination of the two can double block the folate metabolism of bacteria。The synergistic antibacterial action of this product was enhanced compared with that of single drug, and the drug-resistant strains were reduced。
磺胺甲Zometrioprim tablet has good antibacterial action against many kinds of bacteria and microorganisms, especially against Escherichia coli, Haemophilus influenzae, staphylococcus aureus than sulfonamide唑单药明显增强。
The main indications are the following infections caused by sensitive strains:
01: Urinary tract infections caused by Escherichia coli, Klebsiella, Enterobacter, Proteus Mirabilis, Proteus vulgaris and Morrhiza sensitive strains。
02: Acute otitis media caused by streptococcus pneumoniae or Haemophilus influenzae in children over 2 years old。
03Acute onset of chronic bronchitis in adults caused by Streptococcus pneumoniae or Haemophilus influenzae。
04: Intestinal infections and shigella infections caused by sensitive strains of Fowleri or Shigella Song。
05: Treatment of pneumocystis carinii pneumonia, this strain is preferred。
06Prevention of pneumocystis carinii pneumonia can be used in patients with at least one history of pneumocystis carinii disease, or in adults infected with HIV, whose CD4 lymphocyte count is ≤200/mm3 or less than 20% of the total lymphocyte count。
07: Tourist diarrhea caused by enterotoxigenic Escherichia coli (ETEC)。
Roche's new PNH drug, Collolizumab, was declared for sale in the United States
9Genentech today announced that the U.S. FDA has accepted a biologics license application (BLA) for the company's novel complement C5 monoclonal antibody crovalimab for the treatment of paroxysmal sleep hemoglobinuria (PNH).。If approved, crovalimab would be the first subcutaneous once-a-month treatment for PNH that patients could self-administer。
PNHIt is a rare and life-threatening blood disorder caused by the destruction of red blood cells by the complement system。Without treatment, patients have a 35 percent risk of dying within five years。At present, ravulizumab and ekuzumab are the only C5-targeted drugs approved for the treatment of PNH。
Collolizumab is a novel circulating monoclonal antibody targeting complement C5 engineered by Roche through Continuous monoclonal antibody recovery technology (Smart-Ig). Compared with traditional C5 antibody, it has a longer duration with C5。In addition, the binding site of clolizumab differs from that of existing C5 therapies, providing a new treatment option for PNH patients carrying the R885H mutation。
This filing is based on positive results from two Phase III studies (COMMODORE 1 and COMMODORE 2)。
COMMO DORE 1This is a multicenter, randomized, open-label, position-controlled Phase III clinical trial evaluating the safety of clolizumab over ekuzumab or ravulizumab。The primary endpoints were severity and incidence of adverse events (aes), injection site reactions, infusion-related reactions, hypersensitivity reactions, and infections (including epidemic meningococcal meningitis), proportion of patients discontinued due to AE, and drug-target formation in vivo after switching from ekuzuzumab or ravulizumab to clolizumab- Proportion of patients with drug complexes (DTDC)。
COMMODORE 2A multicenter, randomized, open-label, position-controlled Phase III trial evaluating the efficacy and safety of clolizumab (once every 4 weeks, subcutaneously administered) versus ekuzumab (once every 2 weeks, intravenously administered) in patients with PNH who had not received a complement inhibitor。The primary endpoint of the study was control of the proportion of patients without transfusion and hemolysis (lactate dehydrogenase level ≤1.5 x ULN)的患者比例。
The results showed that in the COMMODORE 1 study, patients who switched from ekuzumab or ravulizumab to clolizumab had a benefit and a lower risk;In the COMMODORE 2 study, colorimab was not inferior to ecuzumab。
Previously, Roche completed a Phase III study (COMMODORE 3) of clolizumab for the treatment of PNH patients in China, and based on the results of this study, the product was submitted for priority review in China in August 2022。
Beigene BTK inhibitor Zbrutinib was approved in Chile and Ecuador
9Beigene today announced the latest development in Latin America with the approval of its BTK inhibitor Zbrutinib in Chile and Ecuador for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)。According to Beigene's press release, zebutinib has been approved in 65+ countries or regions worldwide to date。
CLL, one of the most common forms of leukemia in adults, affects white blood cells, or lymphocytes, in the bone marrow, where the proliferation of cancer cells reduces the cells' ability to fight infection and spread to the bloodstream, while invading other parts of the body, including the lymph nodes, liver and spleen。BTK pathway is an important signaling medium of malignant B cells, which can lead to the occurrence of CLL。SLL is a type of non-Hodgkin's lymphoma that primarily affects B lymphocytes in the immune system。SLL is similar to CLL, but its tumor cells are mainly stored in the lymph nodes。
Zbrutinib, a small molecule inhibitor of Bruton's tyrosine kinase (BTK), is currently in an extensive clinical trial program worldwide as a single agent and in combination with other therapies for the treatment of a variety of B-cell malignancies。Because new BTK is continuously synthesized in the human body, Zbrutinib is designed to achieve complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity。
此前,Zbrutinib has already achieved positive results in two global Phase 3 trials targeting CLL/SLL,The SEQUOIA test compared zbrutinib with bendamustine combined with rituximab (B+R regimen) in the treatment of newly treated CLL/SLL patients;ALPINE trial comparing Zbrutinib with ibrutinib in patients with relapsed/refractory CLL/SLL。The two trials included patients from 17 countries, including the United States, China, Australia, New Zealand and several European countries。
According to the latest results of the SEQUOIA trial, presented by Beigene at the 17th International Conference on Malignant Lymphoma (ICML) in June this year, the median follow-up time was 43.At 7 months, zebutinib remained effective in initially treated CLL/SLL patients without 17p deletion and in patients with 17p deletion, and patients with 17p deletion who received Zebutinib continued to show progression-free survival (PFS) benefits, consistent with the randomized cohort。The incidence of atrial fibrillation in the trial was still low, and no new safety signal was found。Zbrutinib continued to be well tolerated and treatment termination rates were low。
ALPINEThe results of the final analysis of the trial were orally reported at the Recent Breakthrough Abstract session at the 2022 Annual meeting of the American Society of Hematology (ASH) and published in the New England Journal of Medicine.。Final progression-free survival (PFS) analysis data showed that Zeebutinib achieved superior efficacy results compared to controls, as evaluated by an Independent Review Committee (IRC) and investigators。In the major predefined subgroups, including patients with different IGHV status and with del(17p)/TP53 mutations, zebutinib showed consistent PFS efficacy。该试验中位随访29.Analysis of preset outcomes at 6 months showed that Zbrutinib was generally well tolerated。

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