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度普利尤单抗小心点,外面全是国产创新药
3 6 Ke· 2026-02-06 04:29
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 ...
药物受理最新动态:赛诺菲(杭州)制药有限公司丙戊酸钠口服溶液补充申请获受理
Xin Lang Cai Jing· 2026-02-03 23:20
受理号CYHB2600219药品名称丙戊酸钠口服溶液药品类型化药申请类型补充申请注册分类企业名称赛 诺菲(杭州)制药有限公司;赛诺菲(杭州)制药有限公司;承办日期2026年2月4日 来源:新浪财经-鹰眼工作室 国家药品监督管理局药品审评中心数据显示,2026年2月4日,赛诺菲(杭州)制药有限公司的丙戊酸钠 口服溶液申请已获受理,受理号为CYHB2600219。 股东名称持股比例认缴出资额认缴出资日期首次持股日期法国赛诺菲药业发展公司75%2160万美元2023 年12月31日2006年10月26日赛诺菲(中国)投资有限公司25%720万美元2023年12月31日2007年05月08 日 声明:市场有风险,投资需谨慎。本文基于第三方数据库自动发布,不代表新浪财经观点,任何在本文 出现的信息均只作为参考,不构成个人投资建议。如有出入请以实际公告为准。如有疑问,请联系 biz@staff.sina.com.cn。 天眼查数据显示,赛诺菲(杭州)制药有限公司成立日期1995年11月30日,法定代表人孙博弘,所属行 业为化学药品原料药制造,企业类型为有限责任公司(外商投资、非独资),企业规模为中型,参保人 数498,注 ...
Sanofi's Venglustat Meets Primary Endpoints in Gaucher Disease Study
ZACKS· 2026-02-03 18:01
Key Takeaways SNY said its phase III LEAP2MONO study met all primary endpoints in GD3 patients versus ERT.Sanofi reported significant, clinically meaningful neurological gains at 52 weeks on SARA and RBANS.SNY said venglustat improved spleen and liver size, was well tolerated, and will advance to filings.Sanofi (SNY) announced that a late-stage study, evaluating venglustat, an investigational oral glucosylceramide synthase inhibitor (GCSi), in patients aged 12 years and older with type 3 Gaucher disease (GD ...
Is Sanofi SA (SNY) One of the Best Cheap Stocks to Buy for 2026
Yahoo Finance· 2026-02-03 12:55
Sanofi SA (NASDAQ:SNY) is one of the best cheap stocks to buy for 2026. On January 27, Citi Research initiated coverage of six large European pharmaceutical stocks, including Sanofi SA (NASDAQ:SNY), AstraZeneca, Roche, Novo Nordisk, GSK, and Novartis. Is Sanofi SA (SNY) One of the Best Cheap Stocks to Buy for 2026 Citi assigned Sanofi a Neutral rating and an €85 price target, a move that positioned the company in the middle of the group. The bank’s analyst Graham Parry commented that pipeline setbacks ha ...
Travel Vaccines Market Size to Reach USD 10.69 Billion by 2033, Driven by Rising International Travel and Preventive Healthcare Awareness – SNS Insider.
Globenewswire· 2026-02-03 09:04
Austin, Texas, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Travel Vaccines Market Size & Growth Analysis: According to SNS Insider, the Travel Vaccines Market was valued at USD 5.22 billion in 2025 and is projected to reach USD 10.69 billion by 2033, expanding at a CAGR of 9.37% during the forecast period of 2026–2033. The steady growth of international tourism, business travel, and migration, along with rising awareness about the risk of vaccine-preventable diseases among travelers, enhances market growth. In an eff ...
UK industry body says Sanofi in breach over RSV therapy claims against Pfizer
Reuters· 2026-02-02 13:42
Sanofi has breached the UK pharma code of practice with unsubstantiated claims that its Beyfortus was more effective than Pfizer's RSV vaccine, the industry's self-regulatory body said on Monday, resp... ...
SpaceX and xAI in Advanced Merger Talks; Verizon Seeks New Consumer Head; Ford F-150s Under NHTSA Scrutiny
Stock Market News· 2026-02-02 11:38
Key TakeawaysSpaceX and xAI, both founded by Elon Musk, are reportedly in advanced discussions for a potential combination, with an announcement possible as early as this week, though the deal remains fluid.Verizon (VZ) has begun identifying potential replacements for Sowmyanarayan Sampath, the current head of its crucial consumer division, according to recent reports.The National Highway Traffic Safety Administration (NHTSA) has initiated an engineering analysis into approximately 1.3 million Ford F-150 (F ...
Sanofi's genetic disorder drug shows mixed results in late-stage trials
Reuters· 2026-02-02 06:02
Group 1 - The core point of the article is that French drugmaker Sanofi's experimental treatment for a genetic disorder shows promise in a late-stage study for Gaucher disease, but did not meet the main goal in a separate trial [1] Group 2 - The treatment demonstrated potential effectiveness in patients with a specific type of Gaucher disease during the late-stage study [1] - However, the results from another trial did not achieve the primary endpoint, indicating challenges in the development process [1]
Press Release: Sanofi’s venglustat met all primary endpoints in a phase 3 study of type 3 Gaucher disease
Globenewswire· 2026-02-02 06:00
Core Insights - Sanofi's investigational drug venglustat has shown positive results in a phase 3 study for type 3 Gaucher disease, meeting all primary endpoints and three out of four key secondary endpoints [1][4][8] Group 1: Study Results - The LEAP2MONO phase 3 study demonstrated that patients receiving venglustat had statistically significant improvements in neurological symptoms compared to those receiving enzyme replacement therapy (ERT), with a p-value of 0.007 [4][8] - Venglustat showed comparable efficacy to ERT in non-neurological outcomes, including changes in spleen volume, liver volume, and hemoglobin levels [4][8] - The study involved 43 patients aged 12 and older, randomized to receive either venglustat or ERT, with a focus on neurological assessments over 52 weeks [13] Group 2: Drug Mechanism and Background - Venglustat is a glucosylceramide synthase inhibitor designed to reduce the accumulation of harmful sugar-and-fat molecules in cells, specifically targeting neurological aspects of Gaucher disease that lack approved therapies [2][12] - Gaucher disease is a rare lysosomal storage disorder characterized by the accumulation of glycosphingolipids, leading to various systemic and neurological symptoms [10] Group 3: Future Plans and Regulatory Path - Sanofi plans to pursue global regulatory filings for venglustat in treating type 3 Gaucher disease [7][8] - The company has a long-standing commitment to rare disease research and has supported the Gaucher disease community for over 40 years [2][4] Group 4: Safety and Tolerability - Venglustat was well tolerated in the study, with no new safety signals reported compared to previous studies; common adverse events included headache, nausea, spleen enlargement, and diarrhea [6][8]
Press Release: Sanofi's Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease
Globenewswire· 2026-01-30 12:00
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease Recommendation supported by safety and efficacy results from several clinical studies and real-world evidenceIf approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...