XJZY(SZ:002332) Di Yi Cai Jing·2026-01-04 13:42Core Viewpoint - The fourth batch of encouraged generic drug catalog has been released, including 21 drug varieties and 47 specifications, addressing the shortage of clinical supplies and the need for domestic drug development [1][2]. Group 1: Drug Catalog Expansion - The fourth batch of the encouraged generic drug catalog includes 21 drug varieties, bringing the total to 110 since the first three batches were released in 2019, 2021, and 2023 [1]. - The new catalog focuses on major diseases such as cancer and rare diseases, as well as chronic diseases, mental health issues, and reproductive health, reflecting the changing disease burden and clinical needs due to demographic trends [1][2]. Group 2: Selection Criteria and Clinical Needs - The selection of drugs for the fourth batch was guided by patient treatment needs, considering clinical guidelines and domestic research status, with input from various experts [2]. - New drugs with novel targets and mechanisms, such as those for chronic kidney disease-related itching, have been included, along with radioactive drugs not yet available in the domestic market [2]. Group 3: Specific Drug Examples - Suvorexant, a new drug for insomnia, has been included in the catalog 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 drugs for rare diseases, such as Deflazacort for Duchenne muscular dystrophy, and aims to enhance reproductive health with low-adverse-effect products [3][4]. Group 4: Challenges in Generic Drug Development - Despite being a major player in generic drugs, China faces challenges in becoming a stronghold in this sector due to technical barriers and insufficient incentives for research and development [5][6]. - As of September last year, only 40 out of 89 drugs listed in the previous three catalogs had been approved for market entry, indicating a significant gap in the availability of generic drugs [5]. Group 5: Future Support and Policy Directions - The government aims to enhance support for the encouraged generic drug catalog through improved clinical trials, key technology research, and expedited review processes [6]. - Policies are being developed to provide market exclusivity for certain categories of drugs, including those for rare diseases and children's medications, to stimulate research and development [6].