国家鼓励仿制药品目录增至110种 辅助生育药物缺口受关注

Core Viewpoint - The fourth batch of encouraged generic drug catalog was released, including 21 drug varieties and 47 specifications, addressing the issue of drug shortages in China and aiming to enhance domestic drug development and production capabilities [1][2]. Group 1: Drug Catalog Expansion - The fourth batch of the catalog is an update after two years, bringing the total number of encouraged generic drug varieties to 110, following three previous batches released in 2019, 2021, and 2023, which included 89 drugs [1]. - The new catalog continues to focus on major diseases such as cancer and rare diseases, while also addressing shortages in treatments for chronic diseases, mental health, and assisted reproduction, reflecting the changing disease burden and clinical needs due to demographic trends [1][2]. Group 2: Selection Criteria and Focus Areas - The selection of drugs for the fourth batch was guided by patient treatment needs, considering clinical guidelines and domestic research status, with input from experts across various fields [2]. - New entries include drugs targeting new mechanisms and indications, such as a treatment for severe itching in chronic kidney disease patients undergoing dialysis and four radioactive drugs not yet marketed domestically [2]. Group 3: Specific Drug Examples - The inclusion of Suvorexant, a drug for insomnia, aims to address the high prevalence of insomnia symptoms among the Chinese population, with 59% of surveyed residents reporting such issues [3]. - The catalog also includes a vaginal sustained-release gel of progesterone for assisted reproduction, which aims to alleviate adverse reactions from traditional injection methods, although it faces regulatory challenges in the domestic market [4]. Group 4: Challenges in Generic Drug Development - Despite being a major player in generic drugs, China faces challenges in becoming a "strong country" in this sector, including technical barriers and insufficient incentives for research and development [5]. - As of September last year, only 40 out of 89 drugs from the previous three catalogs had been approved for market, indicating that many drugs remain unavailable for domestic generic production [5]. Group 5: Future Support and Policy Directions - The government aims to enhance the enthusiasm for generic drug development through policies that provide market exclusivity for certain categories of drugs, including those for rare diseases and children's medications [6]. - Future efforts will focus on supporting clinical trials, key technology research, and expedited review processes for drugs listed in the encouraged generic drug catalog [6].