An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in Japan

This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number: NCT03347422) studies and benefitted from sutimlimab treatment in Japan.
• Study and treatment duration: the period between the participant's completion of the CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

开始日期2021-11-11

申办/合作机构

Sanofi

NCT05791708 / RecruitingN/A

Cold Agglutinin Disease Real World Evidence Registry

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

开始日期2019-12-12

申办/合作机构

Sanofi

NCT03347422 / Completed临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

开始日期2018-03-17

申办/合作机构

Bioverativ, Inc.

100 项与 Sutimlimab 相关的临床结果

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100 项与 Sutimlimab 相关的转化医学

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100 项与 Sutimlimab 相关的专利（医药）

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项与 Sutimlimab 相关的文献（医药）

2024-09-01·Expert Review of Hematology

Novel treatments for immune thrombocytopenia: targeting platelet autoantibodies

Review

作者: Arnold, Donald M. ; Harnett, Brian ; Al‐Samkari, Hanny ; Dalmia, Shreyash ; Al-Samkari, Hanny ; Arnold, Donald

INTRODUCTION:

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelets and an increased risk of bleeding. Platelet autoantibodies target major platelet glycoproteins and cause Fc-mediated platelet destruction in the spleen and reticuloendothelial systems. As mechanisms of disease, platelet autoantibodies are important therapeutic targets. Neonatal Fc receptor (FcRn) antagonists are a new class of therapeutics that reduce the half-life of immunoglobulin G including pathogenic platelet autoantibodies. Spleen tyrosine kinase (Syk) inhibitors interfere with Fc-mediated platelet clearance. Bruton's tyrosine kinase (BTK) inhibitors and B-cell activating factor (BAFF) inhibitors reduce antibody production. The efficacy of these targeted therapies provides new support for the role of platelet autoantibodies in pathogenesis of ITP even these antibodies can be difficult to detect.

AREAS COVERED:

This review includes an in-depth exploration of the pathophysiologic mechanisms of ITP, focusing on autoantibodies. Treatments outlined in this review include a) FcRn antagonists, b) complement inhibitors, c) B-cell directed therapies such as BTK inhibitors, and anti-BAFF agents, d) Syk inhibitors, e) plasma-cell directed therapies, and f) novel cellular therapeutic products.

EXPERT OPINION:

Platelet autoantibodies are often elusive in ITP, yet novel treatments targeting this pathway reinforce their role in the pathogenesis of this autoimmune platelet disorder.

2024-09-01·Journal of the advanced practitioner in oncology

Sutimlimab for Cold Agglutinin Disease

Article

作者: Reid, Mark ; Reid, APRN-CNP, MS, AOCNP, Mark ; A. Fedutes Henderson, PharmD, Bethany ; Fedutes Henderson, Bethany A

Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA) distinct from warm antibody AIHA. One of the ways it is distinct is that CAD is usually not responsive to corticosteroids compared with warm antibody AIHA. Historically, CAD therapy has been limited to immunotherapy or chemoimmunotherapy with varying responses. Cold agglutinin disease also poses a risk for thrombosis and mortality. For patients, fatigue tends to be a common symptom of CAD. The hallmark of CAD is complement-mediated hemolysis, which makes complement inhibitors a critical therapeutic option for patients. Previously, eculizumab, a C5 inhibitor, had limited therapeutic effect for CAD. More recently, sutimlimab, a C1s inhibitor, was shown in two phase III studies to be an efficacious treatment for CAD, improving hemoglobin, hemolysis, and fatigue. However, there is a paucity of medical literature on CAD and on sutimlimab in particular that is geared toward advanced practice providers (APPs). This article aims to provide APPs with a background in CAD and a focus on sutimlimab, assisting these providers in caring for patients with CAD receiving this therapy.

2024-08-01·EClinicalMedicine

Long-term efficacy and safety of continued complement C1s inhibition with sutimlimab in cold agglutinin disease: CADENZA study Part B

Article

作者: Röth, Alexander ; Cid, Joan ; Wardęcki, Marek ; Vos, Josephine M I ; Nishimura, Jun-Ichi ; D'Sa, Shirley ; Jilma, Bernd ; Barcellini, Wilma ; Storek, Michael ; Weitz, Ilene C ; Jayawardene, Deepthi ; Michel, Marc ; Shafer, Frank ; Yamaguchi, Masaki ; Srivastava, Shruti ; Yoo, Ronnie ; Broome, Catherine M ; Wong, Nancy ; Lee, Michelle ; Berentsen, Sigbjørn

Background:

Cold agglutinin disease (CAD) is a rare autoimmune haemolytic anaemia mediated by the classical complement pathway (CP). Sutimlimab selectively targets complement C1s inhibiting classical CP activation. In CADENZA Part A (26-weeks), a placebo-controlled study in patients without recent transfusion history, sutimlimab reduced haemolysis, anaemia, and fatigue, and was generally well tolerated.

Methods:

The CADENZA study (NCT03347422) started in March 2018 (Part A) and completed in December 2021 (Part B). All patients in Part B were eligible to receive sutimlimab for up to 1 year after the last patient completed Part A. Efficacy and safety was assessed throughout Part B, until the last on-treatment visit with available assessment (LV), and after a 9-week washout.

Findings:

In total, 32/39 patients completed Part B; median treatment duration: 99 weeks. Similar sustained improvements in haemolysis, anaemia, and quality of life were observed in patients switching to sutimlimab and those continuing sutimlimab. Mean LV values for the combined group (ie, placebo-to-sutimlimab group and sutimlimab-to-sutimlimab group) improved from baseline for haemoglobin (≥11.0 g/dL on-treatment vs 9.3 g/dL at baseline), bilirubin (≤20.0 μmol/L on-treatment vs 35.0 μmol/L at baseline), and FACIT-Fatigue scores. Following a 9-week washout, inhibition of CP activity was reversed, and haemolytic markers approached baseline levels. Overall, sutimlimab was generally well tolerated throughout the study. No patients developed systemic lupus erythematosus or meningococcal infections. During the 9-week washout, most adverse events could be attributed to recurrence of underlying CAD.

Interpretation:

The CADENZA Part B results support the sustained efficacy and safety of sutimlimab for treatment of CAD; however, upon discontinuation disease activity reoccurs.

Funding:

Sanofi.

项与 Sutimlimab 相关的新闻（医药）

2024-10-14

·Pharmaceutical Technology

Sanofi in talks to sell stake in consumer healthcare unit to CD&R

The decision marks a significant step in Sanofi’s ongoing effort to sharpen its focus on its core areas of innovative medicines and vaccines. Credit: jd8/Shutterstock. Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), a US-based investment company, regarding the potential sale of a 50% controlling stake in its consumer healthcare business, Opella. The move marks a significant step in the company’s ongoing effort to sharpen its focus on its core areas of innovative medicines and vaccines. The French finance ministry, as reported by Reuters , has acknowledged CD&R as a “serious investment fund” with favourable prospects for Opella’s growth and its operations in the country. The ministry has stipulated economic commitments from both Sanofi and CD&R. These include ensuring that Opella’s decision-making centres remain in France and protecting the company’s industrial footprint within the country. The ministry has also emphasised that the proposed sale will not affect the production of Doliprane or other essential medicines by Opella in France, nor the supply of these medicines to the market. See Also: Evergreen Theragnostics Radiopharmaceutical Manufacturing Facility, New Jersey, US Merck Biotech Development Center, Corsier-sur-Vevey, Switzerland The reported valuation of the deal by Bloomberg stands at €15bn ($16.4bn). The fact that CD&R has reportedly outbid PAI Partners suggests a competitive process that reflects the high value and potential of Opella within the broader consumer health market. Opella, with its headquarters in France, employs more than 11,000 people, has operations in 100 countries and manages 13 manufacturing sites and four research and innovation centres. It has a portfolio of 100 brands, including Doliprane, Allegra, Novanight, Icy Hot and Dulcolax. Operating independently within Sanofi, Opella has resources allocated for research and development, production, and digital operations, along with a sustainability roadmap. It reached a 6.3% sales growth at constant exchange rates in 2023, demonstrating a focus on brands and consumer orientation. In October 2024, Recordati reached an agreement with Sanofi to acquire the worldwide rights to Enjaymo, the only approved treatment specifically targeting cold agglutinin disease, a rare B-cell lymphoproliferative disorder.

上市批准生物类似药引进/卖出

2024-10-08

·药融云

赛诺菲出售一款罕见病单抗药物，近11亿美元！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 2024年10月4日，Recordati宣布与赛诺菲达成协议获得其C1s单克隆抗体Enjaymo®（sutimlimab）的全球权利。Enjaymo靶向与经典补体系统激活相关的C1复合物中的丝氨酸蛋白酶C1s，从而抑制溶血过程发生，且不抑制凝集素和替代途径。特别的是，Enjaymo是首个且唯一一款获批用于治疗冷凝集素病的治疗方法。根据协议条款，Recordati将支付8.25亿美元的预付款，如果净销售额达到或超过高峰年预期销售额的上限，还将支付高达2.5亿美元的额外商业里程碑付款。预计交易将于2024年底完成，但需获得监管部门的批准。 Enjaymo于2022年在美国、欧洲和日本获得批准，用于治疗患有冷凝集素病(CAD)的成人溶血。这是一种自身免疫性溶血性贫血疾病，免疫系统中的补体系统会错误地攻击人体健康红细胞进而导致红细胞破裂（溶血）。截图来源：药融云全球药物研发数据库 Enjaymo的批准是基于为期26周的开放标签，单臂关键性3期临床试验的积极结果。试验结果显示，Enjaymo达到了主要疗效终点，54%的患者达到主要复合终点，定义为在治疗评估时间点（第23、25和26周的平均值），患者的血红蛋白（Hgb）水平较基线时增加至少2 g/dL，或Hgb水平达到12 g/dL以上的正常化水平，且从第5周到第26周无需输血。截至2024年8月，Enjaymo®在过去12个月中创造了约1亿欧元（约1.1亿美元）的收入，预计2025 财年的收入将超过1.5亿欧元（约1.65亿美元），最高销售额可达2.5-3亿欧元（2.74-3.29亿美元），是目前水平的两倍多。根据交易完成日期，Recordati 预计2024 年的收入贡献极小。预计该交易将立即增加息税折旧摊销前利润（EBITDA），到 2025 年，利润率将超过目前罕见病公司的平均水平。截图来源：药融云全球药物研发数据库对于 Recordati 来说，这笔交易将进一步推动其进军罕见疾病市场。该公司于2021 年 12 月以近 8.5 亿美元收购了 EUSA Pharma及其四种罕见病药物。近年来，该公司还与葛兰素史克 (GSK)、 Almirall等公司达成了交易。 Recordati首席执行官Rob Koremans评论说：“这项交易符合我们更广泛的战略，重申了我们对罕见病领域的承诺，并与我们的肿瘤学产品组合（特别是 Sylvant®）相辅相成。Enjaymo®进一步扩大了我们在美国、日本和欧洲的罕见病业务，将对我们的收入和利润做出积极贡献。最重要的是，Enjaymo® 具有强大的临床表现，是唯一获准用于治疗 CAD 的产品，它满足了患有这种使人衰弱的疾病的患者尚未得到满足的严重医疗需求。” Recordati 交易发生之际，赛诺菲也正在调整其投资组合。该公司现在计划在新任研发主管Houman Ashrafian和9月30日加入的新任CSO Mike Quigley 的领导下，专注于免疫学和炎症领域。该公司还计划剥离其消费者健康集团 Opella。今年早些时候，赛诺菲将一些早期癌症项目出售给 Vir Biotechnology，并关闭了一个细胞治疗部门，尽管该公司仍在肿瘤学领域进行了一些押注，包括首次涉足放射性制药领域。赛诺菲还投资了多家公司，包括 Ventyx、Vicore和 Graviton。参考资料：公司公告 END 近期热门资源获取后台回复关键词“报告”，获取数十篇药融云出品独家报告后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，了解更多品牌升级详情！

引进/卖出临床3期并购

2024-10-07

·E药经理人

2024诺贝尔生理学或医学奖揭晓；港股首宗18A反向并购发生；20亿美元，AZ引进石药小分子降脂药 | E周药闻

节假日最后一天，备受瞩目的2024年诺贝尔生理学或医学奖重磅揭晓，同去年一样，今年获奖关键词仍离不开“RNA”：科学家Victor Ambros和Gary Ruvkun因发现微小核糖核酸（microRNA）及其在转录后基因调控中的作用，共同获得这一奖项。同在今日，药界另两桩大事发生：石药和阿斯利康达成约20亿美元的合作，以推进开发一款临床前创新小分子脂蛋白(a) (Lp(a)) 抑制剂；亿腾医药与嘉和生物宣布战略合并，港股首宗18A反向并购发生，这也为中国创新药产业整合转型提供了一条新的路径。节前最后一周，多只医药股迎来涨停，这极大提振了市场信心。而在近期，业内除了多起人事变动发生，多起授权交易、战略合作同样也为2024年最后一个季度写下了序章。一起看看近期药圈都有哪些大事发生？政策动态医保局将建立三码合一映射库，提高追溯码信息采集效率：9月30日，国家医保局官网发布了《关于进一步做好医保药品耗材追溯码信息采集工作有关事项的公告》，其中提出，将全面建立追溯码、医保编码和商品码的三码合一映射库，以及药品耗材大中小包装的追溯映射库、各类追溯码的识别库，并免费向定点医药机构和生产、流通企业开放。医保局通报数字个违规使用医保案例：国庆期间，医保局密集曝光了海南、江西、新疆、安徽多起违规使用医保基金典型案例。值得注意的是，海南省妇女儿童医学中心违规金额高达456.94万元。该中心在2022年1月1日至2023年7月31日医保结算周期内开展诊疗过程中存在过度检查、串换收费、重复收费、耗材超标准收费、耗材溢库、药品溢库和其他违法行为（无资质开展精神科项目收费）等多项违规行为，且上述行为均为连续状态。北京亦庄设立首只并购基金，重点关注医疗健康产业投资：近日，北京经济技术开发区康桥医疗健康并购投资基金正式设立，这是北京亦庄设立的首只并购基金。该基金由北京亦庄国际生物医药投资管理有限公司与康桥资本合作设立，总规模30亿元，将重点关注医疗健康产业投资机会，通过探索“控股持有+主动管理”模式引进生物医药成熟项目落地亦庄，为区内生物医药创新生态赋能，持续壮大经开区生物医药产业规模。福建医保局公布福建省第五批医用耗材集采的拟中选结果：近期，福建医保局发布了《福建省第五批医用耗材集中带量采购公告（第7号）》。本次集中带量采购品种为CVC中心静脉导管、PICC 中心静脉导管、造影导管等7类耗材，根据限价要求，本次福建集采将在河南联盟基础上实现价格再度下探，部分品类或会出大幅降价。大型制药石药和阿斯利康达成约20亿美元合作：10月7日，阿斯利康与石药集团签订独家许可协议，以推进早期新型小分子脂蛋白 (a) (Lp(a)) 干扰剂的开发。根据协议条款，阿斯利康将获得石药临床前候选小分子 YS2302018，一种口服 Lp(a) 干扰剂，用于开发新型降脂疗法，以及用于多种心血管疾病的单一疗法或联合疗法，包括与口服小分子PCSK9抑制剂AZD0780联用。石药将从阿斯利康获得1亿美元的预付款，未来还有资格获得高达19.2亿美元的进一步开发和商业化里程碑以及分级特许权使用费。齐鲁制药PD-1/CTLA-4组合抗体获批：9月30日，国家药监局官网显示，齐鲁制药的PD-1/CTLA-4组合抗体（艾帕洛利托沃瑞利单抗）获附条件批准上市，该药物是全球首个获批上市的PD-1/CTLA-4双功能组合抗体，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。药明系回应出售业务传闻：有媒体在近期报道，药明康德和药明生物正在着手出售部分业务，其中药明康德将出售WuXi Advanced Therapies（高端治疗业务），讨论已经进行了数月。药明康德方面表示，正在评估继续WuXi Advanced Therapies运营的选项。此外，还有消息称，药明生物正在与顾问合作，评估对其部分欧洲生产设施的兴趣。对此，药明生物方面表示，公司定期进行业务审查，致力于为投资者在所有资产上实现持续的高投资回报率，不对市场猜测发表评论。 45亿美元，礼来在美新建研发生产中心：10月2日，礼来宣布投资45亿美元新建一个先进生产和药物开发中心，该设施将建于美国印第安纳州黎巴嫩的LEAP研究与创新区。据悉，这座新工厂设计灵活，可生产各种分子疗法，包括小分子药物物质、生物制剂和核酸疗法。超36亿美元，BMS与Prime Medicine合作开发创新细胞疗法：9月30日，Prime Medicine宣布与BMS达成战略研发合作和授权协议，共同开发下一代T细胞疗法，该合作将结合Prime Medicine精准的多重基因编辑能力，以及BMS在开发和商业化创新细胞疗法方面的专长。 10.75亿美元，补体领域又一笔重大交易：10月4日，意大利公司Recordati宣布与赛诺菲达成协议，获得后者补体C1s抗体药物Enjaymo（sutimlimab）的全球销售权益，这是目前唯一获准用于治疗冷凝集素病（CAD）的靶向生物制剂。根据协议条款，Recordati将支付给赛诺菲8.25亿美元的预付款，以及2.5亿美元商业里程碑金额。该交易预计将于2024年底完成。医疗保健巨头CVS Health宣布大幅裁员：全球医疗保健巨头 CVS Health 在近期宣布，为了精简运营，将在全美范围内裁减约2900名员工，此举是公司先前公布的战略调整计划的一部分，主要涉及企业职能岗位，而非零售门店、药房和配送中心的一线员工。阿斯利康BTK抑制剂获FDA优先审评资格：近日，阿斯利康宣布，BTK抑制剂Calquence（acalabrutinib）递交的补充新药申请（sNDA）已经被美国FDA接受并授予优先审评资格，用于治疗初治套细胞淋巴瘤（MCL）成人患者。生物技术康方生物PCSK9抑制剂获批上市：9月30日，国家药监局官网显示，康方生物的PCSK9药物伊努西单抗获批上市，用于治疗原发性高胆固醇血症和混合型高脂血症，以及杂合子型家族性高胆固醇血症。研究结果表明，伊努西单抗在不同心血管分层的患者中均能显著降低低密度脂蛋白胆固醇（LDL-C）超过60%，并能实现包括心血管超高危患者在内LDL-C高比例达标。百济神州PD-1正式在美国上市销售：据报道，10月4日，百济神州宣布替雷利珠单抗已在美国上市销售。替雷利珠单抗于今年获得FDA批准，用于治疗既往接受过系统化疗（不含PD-1/L1抑制剂）后不可切除或转移性食管鳞状细胞癌（ESCC）的成人患者，这也是该药在美国获批的首个适应证。百济神州北美总经理 Matt Shaulis表示，百济神州将替雷利珠单抗的定价较其他获批用于该适应证的PD-1疗法降低了10%。基因泰克买入一款国产CDK抑制剂：9月30日，锐格医药与罗氏基因泰克宣布，双方已达成最终购买协议，根据协议，基因泰克将从锐格医药收购用于治疗乳腺癌的下一代CDK抑制剂产品组合。根据协议条款，锐格医药将获得8.5亿美元的预付款现金，并有资格根据某些预定开发、监管和商业里程碑的实现情况获得额外的现金付款。基因泰克将负责全球的临床开发、生产和商业化。传奇生物新建细胞治疗研发基地：近日，传奇生物宣布正在宾夕法尼亚州费城新建一座先进的研发设施，以推进其下一代细胞治疗产品组合。新的费城设施将增强传奇生物现有的逾350名员工的全球研发组织。康宁杰瑞HER2双抗ADC授权石药集团：近日，康宁杰瑞宣布与石药全资附属公司津曼特生物科技订立许可协议，以在中国内地（不包括香港、澳门或台湾）开发、销售、许诺销售及商业化JSKN003（一种靶向HER2双表位ADC），用于治疗肿瘤相关适应证。康方生物PD-1/CTLA-4双抗卡度尼利获批第二个适应证：9月30日，康方生物宣布，公司独立自主研发的PD-1/CTLA-4双特异性抗体开坦尼一项新适应证上市申请的技术审评建议结论为：批准生产，状态更新为：“制证完毕-待发批件”，该新适应证为：卡度尼利联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性胃或胃食管结合部（G/GEJ）腺癌患者的一线治疗。资本市场亿腾医药与嘉和生物达成战略合并：10月7日，嘉和生物发布重磅交易公告，宣布与亿腾医药达成战略性合并。合并完成后，双方股东将会共同持有合并后主体的权益，同时亿腾医药的大股东将会成为合并后主体的控股股东。据报道，此次亿腾医药和嘉和生物的合并是港交所18A生物科技企业中的第一个反向收购案例，也是港股市场近期唯一公告的反向收购案例。今日，港股嘉和生物复牌后，盘中股价一度暴涨超90%。核药赛道又一起大额融资发生：近期，海外一家名为Aktis Oncology的生物技术公司（率先发现和开发治疗多种实体瘤的新型靶向α放射性药物）宣布，完成超额认购1.75亿美元的B轮融资。此次融资由RA Capital Management领投，RTW Investments和Janus Henderson Investors共同领投。圣诺医药获个人投资者抄底：10月4日，圣诺医药宣布与认购人潘洪辉博士，订立认购协议，潘洪辉博士计划按认购价每股股份约3.36港元认购17,527,696股认购股份，相当于经配发及发行认购股份扩大的已发行股本约16.7%，所得款项总额约为5,890万港元。百德医疗借壳赴美上市：近期，百德医疗正式通过借壳SPAC（特殊目的收购公司）ExcelFin Acquisition Corp，在美国纳斯达克挂牌上市。百德医疗为一家用于肿瘤微创治疗的微波消融医疗器械的开发商及提供商，产品供应及管线产品主要包括微波消融治疗仪及与治疗仪配合使用微波消融针。泽辉生物递交港交所上市申请：泽辉生物递交港交所上市申请，中金公司为保荐人。招股书显示，泽辉生物是一家进入临床研发阶段的生物制药公司，弗若斯特沙利文资料显示，泽辉生物是中国首批获得PSC来源细胞疗法新药临床试验申请（IND）批准的公司、中国唯一一家目前有多项PSC来源细胞治疗资产处于II期临床试验的公司。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

并购带量采购信使RNA

100 项与 Sutimlimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11530	Sutimlimab	-	DB14996

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
溶血性贫血	欧盟	Sanofi	2022-11-15
溶血性贫血	冰岛	Sanofi	2022-11-15
溶血性贫血	列支敦士登	Sanofi	2022-11-15
溶血性贫血	挪威	Sanofi	2022-11-15
冷凝集素病	美国	Bioverativ Therapeutics, Inc.	2022-02-04
溶血	美国	Bioverativ Therapeutics, Inc.	2022-02-04

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性血小板减少症	临床1期	美国	Bioverativ, Inc.	2017-08-14
慢性血小板减少症	临床1期	德国	Bioverativ, Inc.	2017-08-14
慢性血小板减少症	临床1期	英国	Bioverativ, Inc.	2017-08-14
免疫性血小板减少症	临床1期	美国	Bioverativ, Inc.	2017-08-14
免疫性血小板减少症	临床1期	德国	Bioverativ, Inc.	2017-08-14
免疫性血小板减少症	临床1期	英国	Bioverativ, Inc.	2017-08-14
补体紊乱	临床1期	奥地利	Bioverativ, Inc.	2015-07-13
终末期肾脏病	临床1期	奥地利	Bioverativ, Inc.	2015-07-13
大疱性类天疱疮	临床1期	奥地利	Bioverativ, Inc.	2015-07-13

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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


NCT03347396 \| NCT03347422 (CARDINAL \| CADENZA, EHA2024)	临床3期	冷凝集素病	-	SUTIMLIMAB	蓋膚糧蓋廠壓獵範鹽餘(醖構齋壓齋簾積夢淵構) = 簾築糧繭糧願觸範廠觸積遞範艱鏇夢鬱鑰淵蓋 (齋餘繭窪膚繭糧鏇顧簾, 1.55) 更多	积极	2024-05-14
				SUTIMLIMAB	蓋膚糧蓋廠壓獵範鹽餘(醖構齋壓齋簾積夢淵構) = 鹹積壓範壓膚築齋窪遞積遞範艱鏇夢鬱鑰淵蓋 (齋餘繭窪膚繭糧鏇顧簾, 1.53) 更多
NCT03347396 (CARDINAL, Pubmed \| Blood Adv)	临床3期	冷凝集素病	22	Sutimlimab	製築選觸膚製製艱顧鹽(糧淵製範鹹願築蓋網齋) = 窪夢醖廠顧壓鬱壓鏇鏇鏇積憲艱獵築蓋齋範願 (憲窪餘築淵顧構艱顧憲, 5.6) 更多	积极	2023-10-10
NCT05132127 (CTgov)	临床3期	冷凝集素病	7	sutimlimab	糧蓋範鹽襯築範製糧糧(窪構觸觸壓衊網獵齋觸) = 壓鏇夢鑰廠鑰膚餘遞鬱夢壓蓋淵壓構製鹽壓糧 (願膚鹹蓋觸積製醖選醖, 觸範衊廠壓鬱網簾選願 ~ 憲製廠鬱憲蓋築夢獵憲) 更多	-	2023-10-03
CARDINAL and CADENZA (ISTH2023)	临床3期	冷凝集素病	66	PRE-sutimlimab	艱鏇願窪簾築簾糧鏇築(廠鑰艱積壓築獵鑰廠憲) = 襯選憲鹹選醖網壓鬱膚鹽鏇蓋觸齋鑰襯網築夢 (網醖觸遞齋願築鏇膚願 )	-	2023-06-24
				ON-sutimlimab	艱鏇願窪簾築簾糧鏇築(廠鑰艱積壓築獵鑰廠憲) = 網積醖膚遞襯鹹壓獵衊鹽鏇蓋觸齋鑰襯網築夢 (網醖觸遞齋願築鏇膚願 )
NCT03347422 (CADENZA, EHA2023)	临床3期	冷凝集素病	42	Sutimlimab	廠窪鹽遞鹹鹹衊衊廠衊(鹽膚觸餘網獵網廠膚壓) = Raynaud¡¯s phenomenon (1 [2.6%] pts) 夢蓋範廠繭窪鏇鹽壓積 (鏇鏇網獵窪餘鏇築網鬱 ) 更多	-	2023-06-08
				Placebo
NCT03347422 (CADENZA, EHA2023)	临床3期	冷凝集素病	39	Sutimlimab	簾構糧製醖網鬱積襯繭(淵夢選願鏇積構鹽網醖) = Thromboembolic events were observed in 2 (5.1%) pts (transient ischemic attack [n=1]; deep vein thrombosis [n=1]); both events occurred in pts with underlying risk factors for thromboembolism and were assessed as non-serious and unrelated to SUT by the Investigator. 簾鑰夢構衊顧積襯網範 (鹽窪鑰遞淵鹹糧遞範簾 ) 更多	-	2023-06-08
				Placebo
NCT03347396 (CARDINAL, Pubmed)	临床3期	冷凝集素病	22	Sutimlimab	醖齋網繭選構選壓築鹹(構繭鏇壓夢顧鬱齋網獵) = After cessation of sutimlimab, most patients reported adverse events consistent with recurrence of CAD. 廠簾鬱壓獵夢鹹淵遞壓 (構築遞鏇築鏇壓選窪壓 ) 更多	-	2023-05-29
NCT03347422 (CADENZA, CTgov)	临床3期	冷凝集素病	42	sutimlimab (BIVV009) (BIVV009/BIVV009)	餘齋餘壓製範築願餘遞(膚範構鬱壓憲簾網觸壓) = 製膚鏇膚簾範艱壓鹹積衊夢築簾範衊製獵鏇範 (齋壓簾壓膚齋鏇鏇餘顧, 糧簾範壓鹹鏇鹹獵壓網 ~ 夢淵觸蓋壓構醖憲憲鑰) 更多	-	2022-12-23
				placebo+sutimlimab (BIVV009) (Placebo/BIVV009)	餘齋餘壓製範築願餘遞(膚範構鬱壓憲簾網觸壓) = 鬱積積衊鹽齋製淵鏇糧衊夢築簾範衊製獵鏇範 (齋壓簾壓膚齋鏇鏇餘顧, 餘餘襯積襯築範鹹繭糧 ~ 網齋壓製蓋製廠壓鬱網) 更多
NCT03347396 (CARDINAL, CTgov)	临床3期	冷凝集素病	24	BIVV009	願觸鑰艱憲襯築遞繭網(衊齋餘簾淵夢構蓋齋築) = 網夢鏇選選製鑰鑰窪顧鹹顧鏇築窪鹹獵鹽衊壓 (蓋憲繭齋廠鬱淵襯窪鏇, 繭憲簾顧衊觸鏇築餘選 ~ 遞製積簾鑰齋築鑰鹽範) 更多	-	2022-10-31
NCT03275454 (Pubmed) 人工标引	临床1期	免疫性血小板减少症	12	Sutimlimab	製範淵築顧築遞廠蓋膚(選淵願窪醖蓋衊糧遞顧) = Five serious adverse events were observed; one event (migraine) was assessed by the investigator as related to sutimlimab. 蓋鏇獵觸願顧顧遞蓋網 (鬱衊窪獵糧淵繭艱觸製 ) 更多	积极	2022-08-16