Quotient Ltd.

药械追踪 No.1 / 波士顿科学JETSTREAM血管斑块旋切系统获NMPA批准 2024年8月28日，波士顿科学宣布旗下外周动脉疾病（PAD）综合解决方案JETSTREAM血管斑块旋切系统正式获得国家药品监督管理局（NMPA）批准。 JETSTREAM系统适用于外周动脉斑块切除，是一款具有主动抽吸和灌注功能的减容器械，拥有切除纤维斑块、钙化斑块等不同病变类型的能力，适用于股腘动脉原发性病变的经皮腔内斑块旋切预处理治疗，可提高血管内部的通畅程度。 真实世界临床数据显示，使用JETSTREAM血管斑块旋切系统的患者总体手术成功率（术后残余狭窄≤30%）高达98.3%；术后即刻管腔面积改善的比例为86%；与药物涂层球囊（DCB）结合使用术后18个月远期疗效显示，无靶病变血运重建（TLR）达到91%。截至目前，JETSTREAM血管斑块旋切系统已在欧洲、美国、亚太等多地获批应用。 ->点击阅读原文，解锁完整双语新闻 企业动态 No.1 / 赛诺菲多发性硬化重磅产品奥巴捷在中国失去市场独占地位 据报道，最近在中国取消的重大专利包括赛诺菲的多发性硬化症疗法奥巴捷（特立氟胺）。 2024 年 5 月，最高法院公布了三项裁决。这三项裁决包括中国国家知识产权局 （CNIPA） 的两项行政诉讼和一项民事侵权诉讼的上诉。 最高法院支持了国家知识产权局的两项决定，以确认一家未具名的国内仿制药公司请求奥巴捷两项专利（ZL201510052300.9和 ZL201510052299. X 的配方专利）无效，这两项专利原本在 2030 年到期。赛诺菲还寻求通过民事诉讼向 CNIPA 提起专利链接诉讼，但在法院维持国家知识产权局的无效决定后，该诉讼于 2024 年 2 月被驳回。 国内已有两家企业的特立氟胺仿制药获批上市——盛世泰科和辰欣药业，分别与2021年12月31日和2024年6月18日获批。原研奥巴捷最早于2012年在美国获批上市，2019年进入中国，同年进入国家医保目录，随后成为国内占主导地位的多发性硬化疗法。在欧美市场，2023年已有仿制药上市销售。 ->点击阅读原文，解锁完整双语新闻 No.2 / 辉瑞与Flagship达成心血管、肾病领域研发合作 2024年8月29日，辉瑞与Flagship Pioneering达成战略合作，Flagship创立的Quotient Therapeutics公司将与辉瑞合作进行两个研究项目。双方将分析患者组织中发生的体细胞突变，以期发现心血管和肾脏疾病潜在的变革性疗法。 Quotient由Flagship Pioneering于2022年创立，该公司的技术平台以高精度和高分辨率对从患者病灶处获得的组织进行基因测序，揭示体细胞基因突变与疾病之间的联系。 此次合作是继2023年7月Flagship宣布与辉瑞达成战略合作之后最新启动的项目。2023年7月，辉瑞公司宣布与初创公司Flagship Pioneering合作，致力于开发多达10种全新创新药物，以扩展其产品线。  根据协议，双方将首先各自投资5000万美元， Flagship支持的公司在成功推出和销售合作发现和开发的任何实验性治疗方法后，可以从辉瑞处获得高达7亿美元的里程碑和特许权使用费。如果基于合作关系要开发10种药物，那合作的潜在总金额将高达70亿美元。 基于此项合作，辉瑞将获得Flagship的研究平台和临床前研究资源，并将为每种选定药物的开发提供资金，并可以有优先选择权收购这些药物。2024年6月，辉瑞与Flagship旗下专注肥胖领域的ProFound启动首次合作。 ->点击阅读原文，解锁完整双语新闻 行业政策 No.1 / 江西发布“三进”行动，推动集采药品公立医院外落地 近日，江西省医保局决定在全省范围开展集采药品进“零售药店、民营医疗机构、村卫生室（包括社区卫生服务中心/站，下同）”行动（以下简称集采药品“三进”行动），制定并发布《江西省集采药品“三进”行动实施方案》（简称《方案》）。 省级医保部门统一发布《“三进”药品品种》和《“三进”推荐配备药品品种》并动态更新，其中推荐配备品种主要包含适宜在集采药品“三进”行动单位配备销售的常见病、慢性病等集采中选药品。 目前发布的第一批《“三进”药品品种》共591个品种1467个产品，第一批《“三进”民营医疗机构推荐配备药品品种》共333个品种724个产品，第一批《“三进”零售药店、村卫生室推荐配备药品品种》共223个品种466个产品。 在江西省注册的零售药店、民营医疗机构、村卫生室可自愿参加“三进”行动；参加后可在遵循国家医保目录的基础上，从《“三进”药品品种》和《“三进”推荐配备药品品种》中自主遴选药品品种，其中《“三进”推荐配备药品品种》药品选择占比原则上不低于60%。 ▶连锁门店集采药品配备数量原则上不少于50种； ▶单体零售药店集采药品配备数量原则上不少于50种； ▶综合型民营医疗机构集采药品配备数量原则上不少于50种； ▶专科民营医疗机构集采药品配备数量原则上不少于20种； ▶村卫生室集采药品配备数量原则上不少于20种。 此外，《方案》鼓励参加集采药品“三进”行动单位做到“五统一”： ▶统一悬挂集采专识标牌 ▶统一设置集采药品专区（柜） ▶统一双标签公示价格 ▶统一销售价格承诺 ▶统一监督管理 其中，双标签公示价格即同步公示集采药品中选价格和销售价格，相关单位应按集采中选价顺加不超15%销售；一体化管理村卫生室严格落实药品“零差率”销售政策。 ->点击阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻

The deal could potentially lead to the discovery and development of new treatments in cardiovascular and renal disease fields. Credit: sasirin pamai/Shutterstock. Flagship Pioneering and Quotient Therapeutics have entered a strategic partnership with Pfizer to identify new therapeutic targets for cardiovascular and renal diseases. The companies will focus on two research programmes to analyse somatic mutations in diseased tissue. This could lead to the discovery and development of new treatments in the cardiovascular and renal disease fields. Quotient Therapeutics co-founder and CEO, and Flagship Pioneering origination partner Jacob Rubens stated: “Quotient’s Somatic Genomics platform explores the extensive genetic diversity within the 30 trillion cells inside our body. This offers an incredibly rich and unchartered territory for drug discovery. ​“These two research programmes will deploy our unique platform capabilities to identify novel links between genes and cardiovascular or renal disease, which are leading causes of mortality and morbidity around the world.” See Also: Recurrent Head And Neck Cancer Squamous Cell Carcinoma drugs in development, 2024 Metastatic Biliary Tract Cancer drugs in development, 2024 Flagship’s in-house drug development unit, Pioneering Medicines, is tasked with spearheading this initiative. Pioneering will spearhead the discovery process to identify new drug development projects, leveraging Flagship’s multiple bioplatforms. The agreement with Quotient represents the latest endeavour under the strategic partnership between Flagship and Pfizer, initially signed in July 2023 . Flagship Pioneering and Pfizer agreed to focus on developing a new therapy pipeline. The parties agreed to invest $50m each to assess prospects for developing ten single-asset programmes. Pfizer internal medicine research unit chief scientific officer Bill Sessa stated: “This strategic collaboration with Flagship provides an opportunity to explore early discovery work with Quotient’s proprietary platform to potentially unlock new targets for cardiovascular and renal disease. “With our deep cardiometabolic heritage, we will continue to push the boundaries of research innovation to help address significant gaps in care that remain for these patients.”

A freshly drawn-up deal will use Quotient’s platform to identify new links between genes and cardiovascular or renal diseases. Flagship Pioneering and Pfizer have added Quotient into their 10-program partnership, inking a deal to discover new targets for two programs in cardiovascular and renal diseases.The deal fits into a larger equation: Back in July 2023, Pfizer and Flagship Pioneering each put down $50 million to build a 10-program pipeline. The Big Pharma said the VC firm and its bioplatform companies could make up to $700 million in biobucks for each successful drug that emerges from the pact. Now, Flagship-founded Quotient will work with Flagship’s drug development arm—dubbed Pioneering Medicines—to spot somatic mutations in genes that change the progression of heart and kidney diseases, according to an Aug. 28 release.“Quotient’s somatic genomics platform explores the extensive genetic diversity within the 30 trillion cells inside our body. This offers an incredibly rich and unchartered territory for drug discovery,” Quotient CEO and co-founder Jacob Rubens, Ph.D., said in the release. Rubens is also an origination partner at Flagship Pioneering, previously helping form Flagship’s Tessera Therapeutics and Sana Biotechnology.  Quotient will use its platform to identify new links between genes and cardiovascular or renal diseases for the freshly drawn-up research programs, Rubens explained.Flagship Pioneering launched the genomics company in 2022 and publicly unveiled the biotech a year later. The young biotech has homebases in both the U.K. and Cambridge, Massachusetts.Born out of research from teams at the Wellcome Sanger Institute in the U.K. and the University of Texas Southwestern, Quotient tapped Sanger Institute founder Peter Campbell, Ph.D., to serve as the biotech’s chief scientific officer earlier this month.Specific financial details of the deal were not disclosed, nor were specific disease indications shared, though Pfizer’s chief scientific officer of internal medicine research, Bill Sessa, Ph.D., said the pharma would keep pushing boundaries in research innovation to address remaining gaps in cardiometabolic care. Quotient is the second publicly named Flagship offshoot unveiled as part of the Big Pharma-VC pact. This June, Pfizer and Flagship Pioneering picked obesity as the first target in the billion-dollar, multiprogram collaboration. The New York pharma giant is now working with Flagship’s ProFound Therapeutics to find new proteins and determine whether they can be used for new obesity therapeutics.The general purpose of the programs is to address unmet needs within Pfizer’s core strategic areas of interest. The Big Pharma can pluck partnerships from Flagship’s ecosystem that currently spans 40 companies. Though Moderna is included in that network, the partnership will more likely involve companies in earlier-stage development, President of Pioneering Medicines and Flagship General Partner Paul Biondi previously told Fierce Biotech.   Editor's note: This article was updated Aug. 28 at 4:45 pm ET to clarify where Quotient is headquartered.