甘精胰岛素注射液(Ondibta®)
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医药生物行业周报(11月第2周):地方跟进创新药支持政策-20251117
Century Securities· 2025-11-17 10:39
Investment Rating - The report does not explicitly state an investment rating for the industry [2][19]. Core Views - The pharmaceutical and biotechnology sector saw a weekly increase of 3.29%, outperforming the Wind All A index (-0.47%) and the CSI 300 index (-1.08%) during the week of November 10-14, 2025 [3][8]. - Local governments are actively implementing policies to support innovative drug development, with Chongqing aiming to approve 1-3 new drugs annually by 2027 [3][13]. - Flu activity is on the rise, with the percentage of flu-like illness cases reported in southern provinces reaching 5.5%, higher than the previous week and the same period in 2022 and 2024 [3][13]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 3.29%, with all sub-sectors recovering. The leading sub-sectors included pharmaceutical distribution (5.92%), in vitro diagnostics (5.91%), and raw materials (5.09%) [3][8]. - Notable stock performances included Jindike (61.6%), Renmin Tongtai (61.1%), and Chengda Pharmaceutical (58.3%) with significant gains, while *ST Changyao (-33.6%) and Zhend Medical (-11.3%) faced substantial declines [3][11]. Industry News and Key Company Announcements - On November 14, Chongqing's government announced comprehensive support measures for innovative drug development, including funding for research and expedited ethical review processes [3][13]. - Merck announced a $9.2 billion acquisition of Cidara Therapeutics, expected to close in Q1 2026 [3][13]. - Adicon acquired Crown Bioscience for $204 million, aiming to enhance its integrated service platform [3][13]. - Laika Pharmaceuticals entered an exclusive licensing agreement with Qilu Pharmaceutical for LAE002, with potential payments totaling RMB 25.75 billion [3][14]. - Lyell Immunopharma announced a global licensing agreement for LYL273, with significant milestone payments and royalties [3][15]. - MeiraGTx Holdings entered a strategic collaboration with Eli Lilly for gene therapy projects, with upfront and milestone payments exceeding $400 million [3][15].
甘李药业:甘精胰岛素注射液(Ondibta®)上市许可申请(MAA)获得欧盟CHMP 积极意
Ge Long Hui· 2025-11-13 09:21
财经频道更多独家策划、专家专栏,免费查阅>>责任编辑:钟离 格隆汇11月13日丨甘李药业(603087.SH)公布,公司及其欧洲全资子公司甘李药业欧洲有限责任公司 (Gan & Lee Pharmaceuticals Europe GmbH,以下简称"甘李欧洲")于近日收到欧洲药品管理局 (European Medicines Agency,EMA)的通知,甘精胰岛素注射液(商品名:Ondibta®)获得EMA人 用药品委员会(Committee for Medicinal Products for Human Use,CHMP)积极意见。CHMP建议欧盟委 员会(European Commission,EC)批准甘精胰岛素注射液(商品名:Ondibta®)作为 Lantus SoloStar 的生物类似药上市,用于治疗成人、青少年和2岁及以上儿童的糖尿病。CHMP 的建议将进入 EC 审查 阶段,以获得Ondibta®在欧盟、冰岛、列支敦士登和挪威的上市许可,最终决定预计将于明年初做出。 ...