Gan & Lee(SH:603087) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-11-13 23:22Core 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].