Core Viewpoint - Gan & Lee Pharmaceuticals has received a positive opinion from the European Medicines Agency (EMA) for its insulin glargine injection (brand name: Ondibta), recommending it as a biosimilar to Lantus SoloStar for diabetes treatment in adults, adolescents, and children aged 2 and above [2]. Drug Basic Information - Drug Name: Ondibta - Generic Name: Insulin Glargine - Indication: Diabetes - Dosage Form: Injection - Specification: 3ml: 100 units/ml (pre-filled pen) - Applicant: Gan & Lee Pharmaceuticals Europe GmbH [3]. Market Context - According to the International Diabetes Federation (IDF), there are approximately 588.7 million diabetes patients aged 20-79 globally in 2024, with Europe accounting for 65.6 million, representing 11.1% of the global patient population [3]. - The total medical expenditure due to diabetes is estimated at $193 billion globally, with an average annual expenditure of $2,951 per patient [3]. - The diabetes prevalence among the adult population in Europe is 9.8% [3]. Competitive Landscape - As of the announcement date, Sanofi is the main supplier of insulin glargine in Europe, with projected global sales of €2.855 billion (approximately $2.989 billion) for 2024, including €819 million (approximately $857 million) in Europe [3][4]. - Gan & Lee Pharmaceuticals has invested a total of 936 million RMB in research and development for the insulin glargine project as of September 30, 2025 [4].

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 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。 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 & 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 ...