Key Takeaways The FDA granted Breakthrough Therapy to Wayrilz for wAIHA, and Japan awarded Orphan Drug status.Sanofi's designations are supported by LUMINA 2 data, with the late-stage LUMINA 3 study underway.Wayrilz is approved for chronic ITP in the U.S., EU and UAE, and is under review in Japan.Sanofi (SNY) announced that the FDA has granted Breakthrough Therapy designation to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with war ...

摩熵·咨询 查数据·找摩熵 全球在研新药月报 —2026 年1月 扫描二维码 申请摩熵医药数据库免费使用 www.pharnexcloud.com | 目录 | | --- | | 创新药最新政策速递 | | 1.1 重点政策解读 | | 国家药监局发布《关于加强药品受托生产监督管理工作的公告》 | | 国家药监局药审中心发布《境外生产药品上市后备案类变更办理程序》的通告 | | 2025版抗肿瘤药物临床应用指导原则发布 | | 《中华人民共和国药品管理法实施条例》发布 | | ，本月国内新药注册申报分机 | | 2.1本月国内新药获批临床情况 | | 2.2本月国内新药获批上市情况 | | 2.2.1本月获批新药信息 | | 2.2.2本月获批新药简介 | | 三、全球获孤儿药/突破性/快速通道资格认定品种盘点 | | 四、全球在研创新药积极/失败临床结果TOP20 | | Neumora Therapeutics 公布 NMRA-511 1b 期临床积极结果, | | QurAlis Corporation 公司公布其在研疗法QRL-101 1期临床数据 | | 20 GSK全球首创乙肝新药两项3期研究成 ...

Sanofi completes the acquisition of Dynavax Paris, February 10, 2026. Sanofi today announced that it has completed the acquisition of Dynavax Technologies Corporation (Dynavax). The acquisition includes Dynavax’s adult hepatitis B vaccine HEPLISAV-B, which is currently marketed in the US and is differentiated by its two-dose regimen over one month. It also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in phase 1/2 studies, and additional vaccine pipeline projects. This acquisit ...

Sanofi (NASDAQ:SNY) is one of the best healthcare stocks under $50 to invest in. Kepler Capital maintained a Hold on Sanofi (NASDAQ:SNY) on February 3 with a price target of €85. The same day, Sanofi (NASDAQ:SNY) announced plans to execute a share buyback program of €1 billion in 2026, entering into a mandate with an investment service provider for the program on February 2. The terms of the mandate stipulate that Sanofi (NASDAQ:SNY) will repurchase its own shares for a total consideration of up to €1 bill ...

驱动基因阴性NSCLC专题 下一代治疗范式：双抗、IO+ADC 西南证券研究院 2026年2月 分析师：杜向阳 执业证号：S1250520030002 电话：021-68416017 邮箱：duxy@swsc.com.cn 分析师：雷瑞 执业证号：S1250525110001 电话：021-68416017 邮箱：leir@swsc.com.cn 核心结论 驱动基因阴性空间几何？ 报告目录 1 NSCLC全球第一大癌种，驱动基因阴性占三成 2 从一线治疗看驱动基因阴性市场空间几何 驱动基因阴性指肿瘤样本中未检测到明确可靶向的驱动基因突变，分别占中美患者新发NSCLC患者的31%/31%。基于目前中美指南推荐，一线 治疗驱动基因阴性NSCLC晚期患者主要依赖PD(L)-1±化疗的治疗方案，我们测算2030年用于驱动基因阴性NSCLC晚期一线治疗的免疫用药中美 市场规模分别约为75亿元、180亿元。 NSCLC下一代免疫治疗方案齐头并进——双（多）抗、IO+ADC 从临床指南来看，以帕博利珠单抗、阿替利珠单抗为代表的PD(L)-1药物(不)联用化疗已全面覆盖驱动基因阴性一线及后线治疗，临床地位稳定， 但长期维度下 ...

文 | vb动脉网 全球MCE领域累计交易金额已超90亿美元(2022-2025)，诺华、礼来、安斯泰来等巨头纷纷通过合作入 局。 2025年更是迎来爆发。3月，赛诺菲以最高19亿美元收购Dren Bio附属公司，将核心髓系细胞衔接器 （MCE）药物DR-0201收入囊中；12月再续前缘，达成扩展合作，聚焦下一代自身免疫疾病领域的多特 异性MCE疗法开发。7月，葛兰素史克（GSK）与中国泽安生物达成超15亿美元合作，拿下4款MCE肿 瘤新药全球权益。 与巨头狂热形成鲜明对比的是，全球明确布局MCE的Biotech仅个位数，核心技术型企业不足5家。这 一"冰火两重天"，抛出了行业两大核心疑问：为何在技术尚处早期阶段，大药企就急于"抢滩"？为何 MCE前景被普遍看好，却鲜有Biotech入局？ 免疫治疗进入瓶颈期，髓系细胞疗法走到台前 自2013年免疫检查点抑制剂获批以来，T细胞导向的免疫治疗一度成为肿瘤研发的绝对主线。但历经十 余年临床实践，其在实体瘤中的疗效边界正逐步显现。 美国临床肿瘤学会（ASCO）2024年公布的多项临床试验数据显示，PD-1/PD-L1抑制剂单药治疗多数实 体瘤时，客观缓解率（ORR） ...

Core Viewpoint - Sanofi's rilzabrutinib has received breakthrough therapy designation from the FDA and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia (wAIHA), highlighting the urgent need for effective treatments for this rare autoimmune disorder [1][3][4]. Group 1: Designations and Studies - The FDA's breakthrough therapy designation aims to expedite the development of medicines for serious conditions, indicating rilzabrutinib may show substantial improvement over existing treatments [3]. - Rilzabrutinib is currently being evaluated in the LUMINA 2 phase 2b study and the new LUMINA 3 phase 3 study, which compares rilzabrutinib with placebo for wAIHA patients [2]. - There are no approved treatments specifically targeting the underlying causes of wAIHA, which can lead to severe health complications [2]. Group 2: Rilzabrutinib Overview - Rilzabrutinib is a novel oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, already approved for immune thrombocytopenia (ITP) in the US, EU, and UAE, and under review in Japan [4][8]. - The drug addresses immune system dysregulation through multi-immune modulation, making it a potential treatment for various rare diseases [7][8]. - Rilzabrutinib has received multiple regulatory designations, including orphan drug status for autoimmune hemolytic anemia and other rare diseases [5][9]. Group 3: About wAIHA - Warm autoimmune hemolytic anemia is a rare and potentially life-threatening condition, affecting 4 to 24 individuals per 100,000 in the US and EU, and 3 to 10 per million in Japan [6]. - Symptoms include fatigue, dizziness, and serious complications like thromboembolism, emphasizing the need for effective treatments [6]. Group 4: Company Overview - Sanofi is an R&D-driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [10].

Core Insights - Sanofi's rilzabrutinib has received breakthrough therapy designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and orphan drug designation in Japan for the same condition [1][2][3] Group 1: Designations and Studies - The breakthrough therapy designation is based on clinical data from the ongoing LUMINA 2 phase 2b study, which assesses the efficacy and safety of rilzabrutinib for wAIHA patients [2] - A new LUMINA 3 phase 3 study is also underway, comparing rilzabrutinib with placebo in wAIHA patients [2] - There are currently no approved treatments specifically targeting the underlying cause of wAIHA, which can lead to anemia and serious organ damage [2] Group 2: Rilzabrutinib Overview - Rilzabrutinib is a novel oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that aims to restore immune balance through multi-immune modulation [7][8] - It is already approved in the US, EU, and UAE for treating immune thrombocytopenia (ITP) and is under regulatory review for ITP in Japan [4][8] - Rilzabrutinib has received multiple designations, including orphan drug status for autoimmune hemolytic anemia and other rare diseases [5] Group 3: About wAIHA - wAIHA is a rare autoimmune disorder characterized by the destruction of red blood cells, affecting 4 to 24 people per 100,000 in the US and EU, and 3 to 10 people per million in Japan [6] - Symptoms include fatigue, dizziness, palpitations, and shortness of breath, with potential complications such as thromboembolism [6] Group 4: Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [10]

Sanofi (NASDAQ:SNY) is one of the best 52-week low blue-chip stocks to buy right now. On January 29, Sanofi SA (NASDAQ:SNY) reiterated plans to conduct a €1 billion share buyback in 2026. The buyback push comes as the company delivered a strong Q4 2025. ​Sanofi (SNY) Strengthens Shareholder Returns Amid Robust 2025 Performance and Long-Term Growth Outlook Sanofi posted strong fourth-quarter results, driven by surging demand for its asthma drug Dupixent, which it co-developed with Regeneron (REGN). Adjust ...

肿瘤、自免和内分泌是当前生物医药领域公认的三大核心赛道，"药王级"爆款频出。以2024年销售额计算，默沙东Keytruda（K药）、诺和诺德司美格鲁 肽、赛诺菲Dupixent（度普利尤单抗）为全球销售额排名前三的药物，但与PD-1和GLP-1赛道的热闹相比，自免赛道的热度明显偏低。 在赛诺菲刚披露的2025年Q4业绩中，Dupixent单季录得营收42.46亿欧元（约合50.85亿美元），同比大幅增长32.2%；全年销售额达157.14亿欧元（约 188.38亿美元），有望坐稳"自免之王"的宝座。 但在Dupixent一片向好的态势之下，IL-4Rα单抗的竞争格局其实正在悄然生变。 康诺亚的司普奇拜单抗于2024年9月获批，成为全球第二款获批上市的IL-4Rα单抗；先声药业的乐德奇拜单抗、智翔金泰的泰利奇拜单抗、康哲药业的 MG-K10正处于新药上市申请（NDA）阶段，已然蓄势待发；康方生物曼多奇单抗也已达到III期临床终点，即将申报NDA。 崭新的2026年，投资者们可以预见，国产IL-4Rα单抗有望密集获批上市，对"自免之王"Dupixent形成围剿之势。Dupixent还能继续行驶在增长快车道吗？ 对 ...