Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.
The main questions it aims to answer are:
* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)
* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.
Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.
Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.

开始日期2024-11-12

申办/合作机构

Queen Mary University of London

IRCT20240823062844N1

/ Suspended临床3期IIT

Comparison of the effect of rivaroxaban, apixaban and enoxaparin on prevention of venous thromboembolism in morbidly obese patients after bariatric surgery: a clinical trial study

开始日期2024-09-22

申办/合作机构

Shahid Beheshti University of Medical Sciences

NCT06517563

/ Recruiting临床1期

An Open-Label Study to Assess the Effects of VMX-C001 in Combination With an Oral FXa DOAC on the Efficacy of Unfractionated Heparin and of VMX-C001 Alone on the Efficacy of Low Molecular Weight Heparin in Healthy Subjects

A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts:
UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5.
LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.

开始日期2024-08-14

申办/合作机构

Varmx BV初创企业

100 项与依诺肝素钠相关的临床结果

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100 项与依诺肝素钠相关的转化医学

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100 项与依诺肝素钠相关的专利（医药）

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5,702

项与依诺肝素钠相关的文献（医药）

2025-01-02·LEUKEMIA & LYMPHOMA

Thromboprophylaxis with intermediate dose enoxaparin during asparaginase containing induction for young adults with acute lymphoblastic leukemia

Article

作者: Swords, Ronan ; De Sa, Hong ; Leonard, Jessica ; Kaempf, Andy ; Deloughery, Thomas ; Traer, Elie ; Shatzel, Joseph J. ; Lachowiez, Curtis ; Hayes-Lattin, Brandon ; Rakshe, Shauna ; Mathews, Rick

Thrombosis rates among young adults receiving asparaginase (ASP) for acute lymphoblastic leukemia (ALL) can reach 34%, with highest risk during induction. Our institution implemented a standard practice of 1 mg/kg/day enoxaparin administered to young adults with ALL who are treated with ASP during induction. We performed a retrospective analysis of patients who received thromboprophylaxis with enoxaparin 1 mg/kg/day during ASP-containing induction for ALL at Oregon Health & Science University from 2012 to 2023. The primary outcome was the cumulative incidence of thrombosis during induction. Bleeding events were assessed. Sixty-two patients were included in our analysis. Four patients (6.5%; 95% CI 1.8%-15.7%) experienced a thrombotic event. Three events were catheter-associated and 1 event was a distal lower extremity deep vein thrombosis related to myositis. No cerebral sinus thromboses, thrombosis-related deaths or major bleeding events occurred. Intermediate-dose enoxaparin is a promising thromboprophylaxis strategy and warrants further prospective research.

2025-01-01·Cardiology in review

Milvexian: A Focus on a New Oral Anticoagulant that Targets Factor XIa for Thromboembolism Prophylaxis

Review

作者: Birchansky, Joseph ; Frishman, William H.

Drugs that target factor XI and/or XIa have been evaluated as alternatives to existing anticoagulants, in light of studies that indicate that a decrease in Factor XI/XIa levels or activity may result in a lower risk of thrombosis without a significant increase in bleeding risk. Milvexian is an investigational small-molecule factor XIa inhibitor that has recently completed phase 2 clinical trials. Preclinical studies were suggestive of its potential to prevent arterial and venous thrombosis. It was well-tolerated in healthy participants, as well as in participants with mild or moderate hepatic impairment and moderate or severe renal impairment. Notably, patients who received milvexian after knee arthroplasty had a dose-proportional lower incidence of venous thromboembolism compared to patients who received postoperative enoxaparin, and they had a lower incidence of clinically relevant bleeding. A separate phase 2 trial was conducted that assessed the use of milvexian for secondary stroke prevention in patients who had ischemic stroke or transient ischemic attack. It failed its primary objective of establishing a dose-response relationship between milvexian and a composite endpoint of symptomatic ischemic stroke or covert brain infarction. The trial did, however, show a reduction in the relative risk of symptomatic ischemic stroke across most of the treatment groups receiving various dosages of milvexian compared to placebo. The efficacy of milvexian in secondary stroke prevention will be further assessed in an upcoming phase 3 trial. Additional upcoming phase 3 trials will also assess its efficacy in stroke prevention in patients with atrial fibrillation as well as in event reduction in patients with acute coronary syndrome.

2025-01-01·AMERICAN SURGEON

Letter re: Prophylactic Enoxaparin Dosing Using Anti-Factor Xa Levels in Hepatic Surgery Patients: A Pilot Study

Letter

作者: Elsawwah, Jana K. ; Hyon, Stephanie S. ; Harris, Maia A. ; Nemeth, Zoltan H.

154

项与依诺肝素钠相关的新闻（医药）

2024-12-28

·汇聚南药

复星医药中国MNC的激进派

如果说最像美欧MNC的中国医药公司，恐怕莫非复星医药（600196.SH|02196.HK）了。如果要更具象的类比，复星医药与强生这样的医药巨头成长路径有几分相似，尤其在多元化业务布局和全球扩展战略上，都是通过收购兼并玩转了制药、医疗器械和健康消费三个领域。以复星医药系的整体布局看，除了A+H上市公司外，还控股复宏汉霖（02696.HK）、复锐医疗科技（01696.HK）两家港股上市公司，此外就是复星凯特、万邦生化医药、药友制药、南药股份、红旗制药、二叶制药、奥鸿药业、Gland Pharma Limited等一众国内外子公司。这段时间，第十批国谈集采落地又引发了医药行业的大讨论。药企还是哀鸿一片，连创新药企都无法摆脱盈利艰难的窘境，但这也引发了另一个话题就是出海。当国内药企终于将目光投向海外的时候，复星医药已经在海外市场征战多年了，说其是最具全球化视野的中国药企，并不为过。从2024年中期财报的收入结构看，今年上半年公司营收204亿元，其中海外收入55亿元，同比提升15.13%，海外营收占比26.93%。实际上往前捯二十年，复星医药就在谋划海外市场，早在2008年时其海外市场收入就一度冲上过25%。后来国内医药市场进入繁荣期，复星医药海外收入占比似乎没那么显山露水，但海外市场战略是其从未放弃的。 2018年，国内医药市场进入集采前夜，复星医药也再次将海外市场收入占比拉升到20%以上，并且在2021年一度冲上了34.86%。这也为公司对冲国内市场的内卷和政策冲击，带来了极大的缓冲。横向对比，如复星医药这般国内TOP级的综合性药企，海外销售占比超过20%的，实则寥寥无几。也因此，我们基于丰厚的海外市场运营经验和全球资源，判断在下一波中国药企出海潮起时，复星医药将会是中国式MNC的一个标杆。壹|“小目标” 野蛮生长的原点在2024年《胡润全球富豪榜》上，郭广昌以约315亿元人民币的财富位列榜单758位，只是相比2020年时，郭广昌的财富值已经“腰斩”。不过，这并不妨碍时至今日复星医药仍旧是国内医药企业成长历程中最励志的故事之一。某种程度上，复星医药的成功代表着中国民营经济在医药行业的崛起。时间回到1992年，复旦大学毕业留校工作的郭广昌正式辞职，以3.8万元创立上海广信科技发展有限公司开始创业生涯，主营信息咨询业务。次年，公司收入就突破了100万元。而也正是在这一年，郭广昌就把目光转向房地产销售和生物医药领域。哲学专业的他对生物医药不了解，便当即决定拉毕业于遗传工程学的校友梁信军、汪群斌、范伟组织团队进行制药研发，自此广信正式更名“复星”，外界解读为“复旦之星”。 1994年，复星房地产代理营收突破1000万元，同年上海复星实业股份有限公司（2004年改名复星医药）成立；1995年，复星研究三年的成果PCR乙型肝炎诊断试剂推向市场，年收入达1亿元，公司也由此成为上海第一家民营高科技企业。复星医药实际控制人郭广昌图源：互联网自此，郭广昌启动开挂模式，医药也成为复星野蛮生长的原点。成立4年后，1998年复星实业在上海证券交易所发行上市，募集3.575亿元资金。在当时IPO还实行总量控制的审批制，复星成了上海首家民营上市企业。 31岁的郭广昌叩开了资本市场的大门，也开启了其“中国巴菲特”的投资家之旅。通过持续的资本运作和资产并购，复星迅速成为中国最大的民营企业之一，横跨医药、地产、钢铁、矿产、零售、媒体、游戏、证券、保险、期货、私募等领域。 2008年开始，郭广昌将目光投向了海外以及更广的产业，银行、影业、旅游、酒业……截至2023年12月31日，复星集团总资产达人民币8084亿元，由3.8万起家，构建起一个帝国，郭广昌用26年就创造了资本2.1亿倍扩张的神话。了解复星的极速崛起之路，能够让我们对复星系医药产业发展逻辑多一分理解。对于复星的发展，郭广昌认为得益于“在合适的时间做了合适的投资”，但生物制药赚来的第一个“小目标”是起点。当前，复星主要战略聚焦健康、快乐、富足的幸福生态系统。健康板块聚焦医药产品、器械和诊断、健康服务及消费三大领域，医药产业可以说是复星核心中的核心。贰|做对的事复星医药的养成回到医药产业，复星系医药目前仍然坚持的是“运营+投资”共生的路线，这和郭广昌的投资逻辑不无关系。在郭广昌的理念里，永远强调最基本的投资逻辑就是做“对”的事情。投资和收购的目的一定要清晰，当复星集团提供不了或者提供方案的速度太慢时，就会用投资或者收购的方式，将内外部资源打通，为客户提供“令人尖叫”的产品和服务。这一点，在复星系医药发展历史中展现得淋漓尽致。 1998年复星实业上市后，就着手在医疗产业扩张。先是和全国部分省市约150家医院达成合作新建现代生物医学技术研究应用中心；接着通过上市募集到的资金，收购了上海五洋药业健康产品有限公司60％股权；投资控股上海永信维生素有限公司，收购上海创新科技公司，正式在生物医药行业打开局面。 2000年，复星和友谊集团成立了联华超市药房，逐步建立起庞大的线下分销网络；2002年，复星出资6831.68万元，收购了以仿制药业务出名的重庆药友51%的股权；2003年，复星并购了桂林南药，将其研发生产的中国001号新药—抗疟药青蒿琥酯收入囊中。同年，复星出资5亿元，拿下其国药控股49%股权。 2004年，复星又1.3亿收购了主营胰岛素药品的万邦医药75.2%的股权，又通过国药控股投资了一致药业；同年，复星实业更名为“复星医药”，开始将其他业务剥离上市主体，专注于医药健康产业，致力于医药产业链的资源整合。图源：互联网此后，复星医药开始在医疗服务与医疗器械方面布局，先是收购了佛山市禅城区中心医院，又收购了中国第一家外资医院和睦家医疗公司，接着把浙江迪安诊断、岳阳广济医院、安徽济民肿瘤医院、钟吾医院、南阳肿瘤医院等地方性医院也先后收入麾下。 2009年12月，复星医药与Henlix团队合资组建了复宏汉霖，正式开启创新药布局，生物制药的龙头地位正式站稳；2010年，复星医药与美中互利（北京）在香港共同成立美中互利医疗合资公司，在医疗器械领域持续发力。在这个阶段上，复星医药参股的东富龙、金城医药、迪安诊断、佰利联等企业也陆续成功上市，复星医药的资本投资陆续收获果实。如果说国内市场的风生水起让复星医药积累了资本经验，那海外业务的并购和投资，则让复星医药真正有了成为巨头的底气。 2013年，复星医药在以色列成立了子公司Sisram（复锐医疗科技），并以约2.2亿美元的价格收购了以色列医疗美容器械公司Alma Lasers Ltd. 95.2%的股权，布局海外医疗器械市场。同一年，复星医药出资约2250万美元，认购了美国肿瘤检测公司Saladax 30%的股权，成为其单一最大的股东，布局抗癌产业链。 2016年，复星医药出资约1000万美元认购了硅谷呼吸疾病检测公司Spirosure约836万股C轮优先股，占Spirosure发行在外总股份的20.17%；复星和美国Intuitive Surgical（直观医疗器械公司）在中国境内成立了合资公司“复星医疗器械技术（上海）有限公司”，引进了新一代肺癌诊断与治疗机器人。那一年，复星医药还创造了当时中国药企海外并购金额纪录，以12.6亿美元并购印度第一家获得美国FDA批准的注射剂药品生产制造企业Gland Pharma 86%的股权。 2017年，复星医药和关联方复星产业又共同收购了欧洲Breas公司呼吸机器械业务相关公司80%的股权。同年又收购主要从事专利药及仿制药研发、生产和销售的美国IPXL公司。 2020年，复星医药还投资了3.26亿元买入约158万股德国生物公司BioNTech的股票，BioNTech在新冠疫情发生后曾联合辉瑞公司开发了一款新冠疫苗，占据了欧美新冠疫苗市场大半江山，这笔投资也为复星医药带来了超过22亿元的收益。 2023年，复星医药之前收购的Gland Pharma公司又收购了欧洲公司Cenexi （专注于医药合同定制研发和生产服务）100%股权。至此，复星医药的版图轮廓已经清晰展现。从最初的生物医药公司，到现在的医药帝国，复星医药身上有着浓重的PE印记。也恰是如此，让复星医药系成为国内医药公司中最与众不同的。叁|全球布局规模并购与深度整合近十年来，复星医药在海内外并购数量超过130起。从国内走向国际市场的过程中，复星医药的策略并不仅仅是“大手笔并购”，更重要的是如何通过这些并购实现资源整合，最大化释放全球化带来的协同效应。这也是复星医药走过跑马圈地阶段后，给行业最值得参考的答案。可以说复星医药是国内医药企业中，海外投资最多、涉猎品类最广的企业之一，因此也更具有参考性。前文有说到，复星医药在2013年以2.2亿美元收购以色列Alma Lasers，首次大规模进入全球医疗器械市场。凭借Alma Lasers的先进医美设备制造经验，复星迅速拓展了在欧洲、亚洲等国际市场的版图。另外一个案例是印度Gland Pharma，这笔并购完成后，复星医药获得了进入全球高端注射剂市场的机会。当时Gland Pharma为了尽可能开拓全球市场，其制剂生产工厂依次取得了美国FDA、英国 MHRA、德国BGV、巴西国家卫生监督局（ANVISA）、澳大利亚治疗用品管理局 (TGA)、南非MCC（药品管理委员会）世界卫生组织和加拿大卫生部一系列监管机构的认证，在全球市场都有良好口碑。图源：互联网入主Gland Pharma后，复星医药保留了Gland Pharma的核心管理团队，并借助其生产线以及注册平台，进一步扩大了品牌的国际效应，进而曲线进入包括美国在内的海外市场。此外，Gland Pharma公司的业务范围覆盖心脑血管、麻醉、抗感染和糖尿病等，核心产品包括肝素钠、依诺肝素钠注射液、罗库溴铵注射液、万古霉素和重组人胰岛素等多个领域。这些资源与复星医药的创新药产品力结合，实现药品在印度的本土化和市场拓展。与此同时，Gland Pharma和很多全球知名药企都保持着长期合作，这也让复星医药能够迅速融入全球药品供应链网络。仅仅4年，Gland Pharma正式宣布上市，此次募资额645亿卢比也被认为是印度制药公司规模最大的一次IPO。今年6月20日，复星医药公告称，其控股子公司复星医药新加坡公司通过大宗交易出售所持有的990万股Gland Pharma股份（约占总股份6.01%），折合2.11亿美元，但复星医药仍保持对Gland Pharma的控股权。这次并购对于复星医药的全球扩展来说都具有里程碑意义，极大提升了复星医药在全球仿制药和注射剂领域的竞争力。在海外并购之外，复星医药在全球创新布局中的合作同样值得关注。 2017年，复星医药与美国凯特制药合作，成立了“复星凯特”，专注于开发前沿的CAR-T细胞免疫治疗。这次合作带来了全球顶尖的抗肿瘤技术，也让复星医药迅速进入全球最先进的细胞治疗领域，尤其是在肿瘤治疗创新技术上完成了重要一跃。 2021年6月，复星凯特获批上市中国首款CAR-T细胞治疗产品——奕凯达®（阿基仑赛注射液），正式开启中国CAR-T治疗元年，实现了国内细胞治疗领域从“0”到“1”的突破。图源：互联网这种MNC式的“并购+整合+合作”全球化扩展模式，让复星医药逐步适应了全球市场的复杂性，可以视作中国式MNC的一种成长路径。肆|“必选项” 中国MNC的探路者在本土药企中，复星医药的独特性在于其通过市场化的并购策略和全球资本运作，在国际市场上逐步形成了自己的竞争力。但复星医药和强生等传统MNC也不尽相同，最起码两者的驱动模式就不同。强生是研发技术驱动模式，依靠其长期的研发投入和技术积累，推动了全球市场的扩展，形成了独特的技术优势。而复星医药则更偏重于资本驱动模式，并不依赖长期的技术积累，而是通过收购国际领先的医药企业和技术平台，快速弥补自身技术短板。不管是通过并购以色列的Alma Lasers进入了全球医疗美容市场，还是收购Gland Pharma打入了高端注射剂市场，抑或是通过与BioNTech合作引进了mRNA疫苗技术。这些策略极具郭广昌的投资风格，哪里不足快速补哪里。如果把复星医药单纯理解成一个医药投资型公司，也不全面。因为复星医药并未完全依赖外部技术，而是通过这些并购逐步提升了自主研发能力。比如在抗肿瘤药物和生物制品领域，复星医药已经建立自己的研发体系。此外，复宏汉霖作为复星医药的生物制药平台，也已经在全球范围内取得了一定的成绩，特别是在PD-1和HER2抗体药物的研发方面展现出强劲的竞争力。而在两个点上，我们需要进一步观察复星医药：一个是复星医药的成长动能更多是通过投资收益获取。数据显示，2021年至2023年，复星医药的投资收益分别为46.24亿元、43.78亿元、35.02亿元，同期归属净利润分别为47.29亿元、37.31亿元、23.86亿元，可见其盈利高度依赖投资收益。图源：上市公司财报在日趋紧张的国际地缘关系和逆全球化思潮中，对于复星医药乃至更多出海的中国药企来说，资产并购的难度也在肉眼可见的提升，而已并购的资产也需要进一步提升控制力与盈利能力。其二，资本驱动模式可能带来高杠杆风险不可忽视。如何在保持并购扩展的同时降低财务压力，是复星医药着重需要思考的问题。截至2024年6月末，复星医药担保总额已高达331.81亿元，占归属于上市公司股东的净资产的比例为74.12%（正常情况下不允许超过50%），一旦子公司暴雷，后果不堪设想。图源：上市公司财报无论如何，在国际化布局及资源整合方面，复星医药已经遥遥领先于其他本土药企，这对于其对冲国内发展环境的局促有着极为重要的意义。目前，复星医药拥有近1000人的海外商业化团队，覆盖美国、欧洲、非洲等海外市场，致力于成为全球领先的医疗创新整合者。毫无疑问，其海外扩张的每一步，都将是中国医药行业出海的经验累积。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：原创王金星多肽链往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

财报并购

2024-12-20

·PipelineReview

Regeneron to Advance Two Factor XI Antibodies into a Broad Phase 3 Program Following Positive Phase 2 Proof-of-concept Results

Investigational REGN7508 (catalytic domain) and REGN9933 (A2 domain) are being evaluated for their potential to control thrombosis while minimizing bleeding risk in a variety of patient populations and clinical settings Evaluated against current standards of care, single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects Phase 3 program to be initiated in 2025 TARRYTOWN, NY, USA I December 19, 2024 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive Phase 2 results for two novel monoclonal antibodies targeting distinct domains of Factor XI. REGN7508 (catalytic domain) is designed to maximize anticoagulant activity while minimizing bleeding risk, and REGN9933 (A2 domain) is designed to provide an additional option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Per the Phase 2 results, there was a robust antithrombotic effect for each antibody, and no clinically relevant bleeding was observed in any treatment arm. “Our Factor XI antibodies targeting the catalytic and A2 domains were rigorously evaluated alongside current standards of care and showed clear evidence of antithrombotic effect with an encouraging safety profile after a convenient single dose,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron. “These latest Phase 2 results add to our preclinical data that showed prolongation of activated partial thromboplastin clotting time was greater with REGN7508 and similar with REGN9933, compared to other Factor XI-targeted agents. Together, these clinical and preclinical data, along with compelling genetic evidence, give us confidence in targeting multiple distinct domains of Factor XI to potentially offer tailored therapies for patients with different bleeding risk profiles and in a variety of treatment settings. We are eager to advance REGN7508 and REGN9933 into a broad Phase 3 program beginning in 2025.” Regeneron conducted two open-label, active-controlled Phase 2 trials (ROXI-VTE-I and ROXI-VTE-II) in the same centers under similar protocols to evaluate REGN7508 and REGN9933 for the prevention of asymptomatic (detected by venogram between day 8 and 12) or symptomatic venous thromboembolism (VTE) after unilateral total knee arthroplasty. In ROXI-VTE-I, patients were randomized to receive either a single intravenous (IV) dose of REGN9933, daily enoxaparin, or twice daily doses of apixaban until the time of venography. In ROXI-VTE-II, patients were randomized to receive a single IV dose of REGN7508 or daily enoxaparin until the time of venography. In contrast to trials evaluating other Factor XI antibodies, administration of all treatments began 12 to 24 hours after surgery (generally one day post-operation) in both trials, consistent with the approved administration of the active comparators. On the measure of VTE rates at venogram following surgery, a pooled analysis across both trials showed REGN7508 was superior to enoxaparin and non-inferior to apixaban, and REGN9933 was non-inferior to enoxaparin. All VTE events were asymptomatic, except for one symptomatic case of pulmonary embolism in the apixaban arm. Results were as follows: * Superiority met ^ Non-inferiority met with a margin of 9% There was no major bleeding (including surgical site bleeding) or clinically relevant non-major bleeding in any arm; the only treatment-related adverse events (AE) in any arm was one case of minimal bleeding (contusion) reported in the enoxaparin arm of ROXI-VTE-I. There were no treatment-related serious AEs (SAEs) in any arm. There were also no AEs in any arm leading to trial discontinuation or dose interruption/modification, and no AEs of special interest or deaths in these trials. Across both trials, AE rates were generally similar among the treatment arms (ROXI-VTE-I: REGN9933=22%, enoxaparin=21%, apixaban: 25%; ROXI-VTE-II: REGN7508=22%, enoxaparin: 25%). The safety and efficacy of REGN7508 and REGN9933 have not been evaluated by any regulatory authority. About Thrombosis Thrombosis, otherwise known as clot formation, is responsible for one in four deaths worldwide. Due to bleeding concerns, current standard-of-care anticoagulants are underutilized and current oral agents are often associated with poor adherence. There is an unmet need for treatments that can help prevent thrombosis without increased bleeding risk. About Regeneron’s VelocImmune ® Technology Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent ® (dupilumab), Libtayo ® (cemiplimab-rwlc), Praluent ® (alirocumab), Kevzara ® , Evkeeza ® (evinacumab-dgnb), Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz ® (pozelimab-bbfg). In addition, REGEN-COV ® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite ® technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center ® , which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn . SOURCE: Regeneron Pharmaceuticals

临床结果上市批准临床2期临床3期

2024-12-19

·药明康德

超1.4亿美元助力潜在“first-in-class”双抗开发；开发穿越血脑屏障的基因疗法，安斯泰来达成超13亿美元合作……

▎药明康德内容团队编辑推动潜在“first-in-class”双抗开发，新锐完成超1.4亿美元A轮融资 Ottimo Pharma公司今日宣布完成超过1.4亿美元的A轮融资。本次融资将加速其主打候选药物jankistomig的开发进程。Jankistomig是一款潜在“first-in-class”的PD-1/VEGFR2双功能性抗体，适用于多种实体瘤适应症，提供静脉输注（IV）和皮下注射（SC）两种形式。同时，融资获得资金还将用于推进后续双功能产品管线的开发。 Jankistomig的设计不同于传统的双特异性抗体，其双臂中的任何一臂均可与PD-1或VEGFR2结合。它通过靶向免疫检查点蛋白和血管生成，为癌症治疗提供解决方案。这一创新方法旨在提供更广泛的治疗窗口，不受肿瘤VEGF水平的限制，有潜力改善多种实体瘤适应症的治疗结果。目前，jankistomig正在进行支持IND的临床前研究，计划于2025年底提交IND申请。穿越血脑屏障，安斯泰来超13亿美元开发神经疾病基因疗法 Sangamo Therapeutics与安斯泰来（Astellas）今天宣布，双方已签署一项许可协议。安斯泰来将使用Sangamo开发的创新专有神经营养型腺相关病毒（AAV）衣壳STAC-BBB，该衣壳在非人灵长类动物中已展示出强大的血脑屏障穿越能力和神经细胞转导效果。协议赋予安斯泰来对一个靶点的全球独家使用权，同时允许其在支付额外许可费用后，将使用权扩展至最多4个其他靶点，以通过静脉注射基因药物治疗某些神经系统疾病。根据协议条款，Sangamo将负责完成与STAC-BBB衣壳相关的技术转移，而安斯泰来将承担所有研究、临床前及临床开发、监管事务、生产以及最终基因治疗产品的全球商业化工作。Sangamo将从安斯泰来获得2000万美元的预付款，并有资格在五个潜在神经疾病靶点中，通过许可费用和里程碑付款获得高达13亿美元的额外付款。再生元两款创新单抗疗法挺进3期临床再生元公司（Regeneron Pharmaceuticals）今日宣布，其针对凝血因子XI（FXI）不同结构域的两种创新单克隆抗体在2期临床试验中取得了积极结果。REGN7508（靶向FXI催化结构域）旨在最大限度地提高抗凝活性，同时将出血风险降至最低；REGN9933（靶向FXI蛋白A2结构域）则为那些具有最高出血风险且不适合现有抗凝药物的患者提供了额外选择。根据2期临床结果，两种抗体均表现出显著的抗血栓效果，且所有治疗组均未观察到与治疗相关的临床显著出血事件。基于这一积极结果，该公司计划将这两款抗体推进3期临床开发阶段。再生元公司开展了两个开放标签、活性对照的2期试验（ROXI-VTE-I和ROXI-VTE-II），以评估REGN7508和REGN9933在单侧全膝关节置换术后预防无症状或有症状静脉血栓栓塞（VTE）的效果。在ROXI-VTE-I试验中，患者被随机分配接受单次静脉输注REGN9933、每日一次enoxaparin或每日两次apixaban直至静脉造影检查。在ROXI-VTE-II试验中，患者被随机分配接受单次静脉注射REGN7508或每日一次enoxaparin直至静脉造影检查。在术后静脉造影检测VTE发生率这一指标上，结合两项试验数据的综合分析显示，REGN7508和REGN9933均达到与活性对照相比的非劣效性标准，具体试验结果如下： ▲REGN7508和REGN9933的2期临床试验结果（图片来源：参考资料[3]） ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Ottimo Pharma Raises over $140 Million in Series A Financing. Retrieved December 19, 2024, from https://ottimopharma.com/ottimo-pharma-raises-over-140-million-in-series-a-financing/ [2] Sangamo Therapeutics and Astellas Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases. Retrieved December 19, 2024, from https://investor.sangamo.com/news-releases/news-release-details/sangamo-therapeutics-and-astellas-announce-capsid-license [3] Regeneron to Advance Two Factor XI Antibodies into a Broad Phase 3 Program Following Positive Phase 2 Proof-of-concept Results. Retrieved December 19, 2024, from https://www.globenewswire.com/news-release/2024/12/19/2999725/0/en/Regeneron-to-Advance-Two-Factor-XI-Antibodies-into-a-Broad-Phase-3-Program-Following-Positive-Phase-2-Proof-of-concept-Results.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

引进/卖出基因疗法临床申请临床2期临床3期

100 项与依诺肝素钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03674	依诺肝素钠	B01AB05	DB01225

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肺栓塞	欧盟	Techdow Pharma Netherlands BV	2016-09-15
肺栓塞	冰岛	Techdow Pharma Netherlands BV	2016-09-15
肺栓塞	列支敦士登	Techdow Pharma Netherlands BV	2016-09-15
肺栓塞	挪威	Techdow Pharma Netherlands BV	2016-09-15
血栓形成	中国	Sanofi	2003-12-31
心肌梗塞	美国	Sanofi-Aventis U.S. LLC	1993-03-29
不稳定型心绞痛	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1993-02-12
非q波心肌梗死	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1993-02-12
ST段抬高心肌梗死	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1993-02-12
静脉血栓栓塞	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1993-02-12
静脉血栓形成	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	1993-02-12

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床3期	澳大利亚	Sanofi	2020-10-27
新型冠状病毒感染	临床3期	比利时	Sanofi	2020-10-27
新型冠状病毒感染	临床3期	南非	Sanofi	2020-10-27
小细胞肺癌	临床3期	瑞典	Sanofi	2008-06-01
腹部肿瘤	临床3期	日本	Sanofi	2007-03-01
髋部骨折	临床3期	日本	Sanofi	2006-07-01
胰腺腺癌	临床3期	德国	Sanofi	2004-04-01
胰腺癌	临床3期	德国	Sanofi	2004-04-01
急性心肌梗塞	临床3期	美国	Sanofi	2002-10-01
急性心肌梗塞	临床3期	中国	Sanofi	2002-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04367831 (IMPROVE, CTgov)	临床4期	新型冠状病毒感染 \| 静脉血栓形成 \| 动脉血栓形成 ... 更多	94	Enoxaparin/Lovenox Intermediate Dose+Heparin Infusion (Intervention Arm: Intermediate-dose Anticoagulation)	壓簾鏇鏇壓廠遞遞製蓋(鹽窪鬱繭憲繭鬱鹽廠糧) = 鹹選鬱觸襯襯窪淵鑰衊構夢膚網壓構蓋艱製艱 (醖積選襯鑰鏇顧獵構衊, 窪觸膚壓積糧艱願獵製 ~ 齋獵醖壓獵獵糧鬱鏇顧) 更多	-	2024-12-10
				Enoxaparin Prophylactic Dose+Heparin SC (Control Arm: Prophylaxis)	壓簾鏇鏇壓廠遞遞製蓋(鹽窪鬱繭憲繭鬱鹽廠糧) = 獵壓窪鏇襯鏇獵築築夢構夢膚網壓構蓋艱製艱 (醖積選襯鑰鏇顧獵構衊, 網鏇繭餘繭糧簾積鹹築 ~ 壓淵廠蓋築膚觸築鏇構) 更多
AUA2024	N/A	-	-	Apixaban 2.5mg	製繭膚窪鑰夢夢構艱齋(獵齋願鏇積鹹鹹鏇簾鑰) = 積簾齋獵願遞餘餘遞築鬱網醖觸糧製窪構鑰簾 (艱簾糧遞選網蓋餘顧鑰 ) 更多	积极	2024-05-01
				Enoxaparin 40mg	製繭膚窪鑰夢夢構艱齋(獵齋願鏇積鹹鹹鏇簾鑰) = 鏇顧醖選遞衊蓋廠衊憲鬱網醖觸糧製窪構鑰簾 (艱簾糧遞選網蓋餘顧鑰 ) 更多
NCT03339349 (CTgov)	临床2期	肺栓塞 \| 静脉血栓形成 \| 创伤和损伤 ... 更多	80	Enoxaparin	齋繭醖淵築膚壓觸獵醖(齋醖襯積鏇齋壓鹹膚齋) = 艱築築糧鏇範齋衊簾選壓衊簾襯繭糧壓構築觸 (齋壓繭齋鏇網觸獵膚構, 築蓋鑰築繭餘顧糧獵鏇 ~ 衊積鑰願製夢廠憲鑰繭) 更多	-	2024-01-31
NCT04409834 (COVID-PACT, CTgov)	临床4期	新型冠状病毒感染 \| 动脉血栓形成 \| 静脉血栓栓塞	390	Unfractionated Heparin IV+Clopidogrel+Enoxaparin 1 mg/kg (Full-dose Anticoagulation (FDAC))	衊鹹顧獵願範鑰範膚簾(網觸獵夢鬱糧鹹鏇願範) = 窪願餘簾膚網繭襯齋構鹹蓋願壓鹹憲範膚構繭 (鹽艱築製糧憲壓繭憲鹹, 齋齋範築憲夢鬱繭繭膚 ~ 積憲遞艱廠廠醖夢選壓) 更多	-	2024-01-19
				Unfractionated heparin SC+clopidogrel+Enoxaparin 40 mg SC (Standard-dose Prophylactic Anticoagulation (SDPAC))	衊鹹顧獵願範鑰範膚簾(網觸獵夢鬱糧鹹鏇願範) = 醖齋醖齋構鏇壓觸醖憲鹹蓋願壓鹹憲範膚構繭 (鹽艱築製糧憲壓繭憲鹹, 繭築範憲顧範膚簾壓製 ~ 鬱齋夢夢製淵範壓簾繭) 更多
NCT04427098 (INHIXACOVID19, Pubmed \| BMC Infect Dis)	临床2期	新型冠状病毒感染	98	Intermediate dose enoxaparin	憲餘醖觸襯構醖壓衊餘(膚獵構構網鑰顧淵願獵) = 廠夢鏇鑰膚鏇淵齋鏇顧膚夢遞醖顧鹽鏇網網餘 (簾膚簾獵糧選夢糧鏇簾 ) 更多	积极	2023-10-24
				enoxaparin (Observational cohort (OC))	膚壓鹽簾顧衊餘積醖構(淵餘築網遞醖鬱積膚艱) = 簾願觸蓋獵顧衊膚鏇繭憲製鏇憲築衊簾築鬱襯 (膚憲壓鑰觸廠艱艱觸鹹, 11 ~ 21) 更多
NCT02744092 (CANVAS, CTgov)	N/A	肺栓塞 \| 肿瘤 \| 静脉血栓形成 ... 更多	811	Rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	憲選糧糧餘淵壓選積鹽(選衊蓋膚選蓋範衊襯衊) = 獵夢艱餘顧餘廠遞鹽構鏇醖衊網鑰夢艱夢憲網 (鏇醖蓋襯遞壓襯襯築糧, 壓網簾衊選獵齋獵醖齋 ~ 鑰製餘夢選憲繭製夢鹽) 更多	-	2023-10-03
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	憲選糧糧餘淵壓選積鹽(選衊蓋膚選蓋範衊襯衊) = 膚獵淵簾積廠選艱壓齋鏇醖衊網鑰夢艱夢憲網 (鏇醖蓋襯遞壓襯襯築糧, 鑰膚觸繭衊鬱艱積淵膚 ~ 願壓鏇遞憲觸蓋積淵衊) 更多
NCT04406389 (IMPACT, CTgov)	临床4期	新型冠状病毒感染	14	Unfractionated heparin+Fondapariniux+Enoxaparin sodium (Intermediate Dose Prophylaxis)	構膚鹹憲醖製壓夢膚襯(蓋簾艱窪膚顧製獵鏇網) = 齋膚淵廠廠廠網蓋淵淵壓醖製淵齋糧壓鹹築艱 (願齋遞鬱壓觸襯醖範糧, 鹹艱網繭積壓鹽製鹽鬱 ~ 製淵憲願夢廠簾壓顧壓) 更多	-	2023-09-21
				Unfractionated heparin+Fondapariniux+Argatroban+Enoxaparin sodium (Therapeutic Dose Anticoagulation)	構膚鹹憲醖製壓夢膚襯(蓋簾艱窪膚顧製獵鏇網) = 範顧衊網艱淵鏇顧廠艱壓醖製淵齋糧壓鹹築艱 (願齋遞鬱壓觸襯醖範糧, 願繭網衊範鬱夢鏇膚衊 ~ 顧鬱顧選遞鬱範製膚遞) 更多
ISTH2023	N/A	出血 \| 静脉血栓栓塞	-	Enoxaparin	繭夢築築築醖壓醖製獵(窪顧顧壓齋醖願鹹醖簾) = 鏇構醖壓蓋夢顧積憲艱繭觸夢鏇膚餘鑰膚選築 (鏇鑰襯構網鏇窪顧鏇醖 ) 更多	-	2023-06-24
RIETECAT-RI (ISTH2023)	N/A	肿瘤 \| 肾功能不全 \| 静脉血栓栓塞	-	Recommended doses of enoxaparin	膚選壓蓋鹹膚蓋構膚積(鹹獵醖蓋鬱艱繭壓觸繭) = 選願糧鏇廠淵襯繭鹹餘繭醖簾膚憲廠顧憲鬱廠 (範鏇網繭艱窪願鬱壓齋 ) 更多	不佳	2023-06-24
				Higher doses of enoxaparin	膚選壓蓋鹹膚蓋構膚積(鹹獵醖蓋鬱艱繭壓觸繭) = 襯襯鬱願蓋壓網築鬱糧繭醖簾膚憲廠顧憲鬱廠 (範鏇網繭艱窪願鬱壓齋 ) 更多
ISTH2023	N/A	出血 \| 肥胖 \| 静脉血栓栓塞	-	Enoxaparin	蓋廠廠鬱鑰積壓觸鑰夢(獵膚齋構範獵蓋製廠蓋) = 選鬱鬱窪淵製範觸鏇選艱鏇選鏇醖鬱壓鑰獵膚 (糧獵觸願繭選窪襯顧選 ) 更多	-	2023-06-24
				Enoxaparin	蓋廠廠鬱鑰積壓觸鑰夢(獵膚齋構範獵蓋製廠蓋) = 網餘築積衊鹽繭廠鏇衊艱鏇選鏇醖鬱壓鑰獵膚 (糧獵觸願繭選窪襯顧選 ) 更多