第四批鼓励仿制药品目录发布,优先收录新靶点、新作用机制产品
Xin Jing Bao·2026-01-04 06:00

Core Insights - The National Health Commission of China, in collaboration with various governmental departments, has developed the "Fourth Batch of Encouraged Generic Drug List," which includes 21 varieties and 47 specifications of drugs aimed at addressing clinical supply shortages and patent expirations [1][2] Group 1: Drug Selection Criteria - The selection of drugs is based on clinical needs and disease burden, focusing on enhancing treatment adherence and ensuring the feasibility of research and production [1] - The list prioritizes products with new targets and mechanisms, particularly those addressing weak areas in domestic research, such as a drug for alleviating moderate to severe itching in chronic kidney disease patients undergoing dialysis [1] - It includes four radioactive drugs that have not yet been marketed domestically, covering therapeutic, diagnostic, and localization uses [1] Group 2: Inclusion of Effective Products - The list favors drugs that have been recommended in international first-line guidelines, such as Suvorexant for treating insomnia, which addresses difficulties in falling asleep and reduces daytime drowsiness and fatigue [1] - This inclusion aims to provide more options for clinical use in response to the inadequacy of currently available medications in China [1] Group 3: Focus on Reproductive Health - The list also emphasizes low-adverse reaction iterative products to support fertility policies, such as progesterone vaginal sustained-release gel and suppositories, which mitigate adverse reactions from long-term high-dose injections during assisted reproductive technology [1] - The selection considers the accessibility of medications, prioritizing products already in clinical practice domestically, such as Deflazacort for treating Duchenne muscular dystrophy [2]