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《第四批鼓励仿制药品目录》发布 透析、助眠、优生有新盼
Zhong Guo Jing Ji Wang· 2026-01-05 03:05
Core Viewpoint - The National Health Commission of China, in collaboration with various governmental departments, has released the "Fourth Batch of Encouraged Generic Drug List" to enhance drug supply security and address clinical shortages in the market [1]. Group 1: Drug Selection Criteria - The list includes 21 drug varieties and 47 specifications, focusing on patient treatment needs and addressing gaps in the market [2]. - Priority is given to products with new targets and mechanisms, such as difelikefalin for chronic kidney disease-related itching [2]. - The list also includes drugs recommended in international guidelines, like suvorexant for insomnia, to provide more treatment options [2]. - Products with lower adverse reactions, such as progesterone formulations for assisted reproduction, are prioritized to support fertility policies [2]. - The selection considers accessibility, including products already practiced clinically in China, like deflazacort for Duchenne muscular dystrophy [2]. Group 2: Drug List Details - The list features various drugs, including: - Bexarotene (topical gel, 1%) [3] - Deflazacort (tablets in multiple dosages) [3] - Difelikefalin (injection, 65mcg/1.3mL) [3] - Suvorexant (tablets in multiple dosages) [4] - Progesterone (vaginal gel and suppository) [5] - Additional drugs include midostaurin, opicapone, and others, with various formulations and dosages [4][5][6].
我国发布第四批鼓励仿制药品目录
Xin Lang Cai Jing· 2026-01-04 19:01
Core Viewpoint - The fourth batch of encouraged generic drug catalog includes 21 varieties and 47 specifications, focusing on patient treatment needs and addressing weak R&D areas in domestic companies [1] Group 1: Drug Categories - The catalog includes drugs for oncology, nervous system, assisted reproduction, and radioactive diagnosis [1] - New target and mechanism products are prioritized, such as a drug for alleviating moderate to severe itching in chronic kidney disease patients undergoing dialysis [1] Group 2: Drug Effectiveness and Recommendations - Products already recommended in first-line guidelines abroad are prioritized, like Suvorexant for treating insomnia, which addresses difficulties in falling asleep and reduces daytime drowsiness and fatigue [1] - The catalog also emphasizes low adverse reaction iterative products, such as progesterone vaginal sustained-release gel and suppositories for assisted reproduction, which mitigate injection-related side effects [1] Group 3: Accessibility and Clinical Practice - The selection process considers drug accessibility and prioritizes products with existing clinical practices in China, such as Deflazacort for treating Duchenne muscular dystrophy [1]
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]