不到一个月，百款仿制药上市申请被拒

Core Insights - The recent surge in drug notification letters from the National Medical Products Administration (NMPA) indicates a tightening of approval processes for generic drugs in China, with 167 drugs involved since December, including 102 generic drug applications being rejected or withdrawn, doubling the number from November [2][6]. Group 1: Drug Approval Trends - A total of 102 generic drug applications were either rejected or voluntarily withdrawn in December, primarily affecting cardiovascular, metabolic, neurological, respiratory, anti-infective, oncology, ophthalmology, dermatology, and digestive system treatments [2][5]. - The most affected drug was Bilastine, with six manufacturers, including Shandong Langnuo Pharmaceutical and Jiangsu Hechen Pharmaceutical, facing difficulties in their applications [3][5]. - Other notable drugs with multiple applicants facing rejection include the antipsychotic drug Brexpiprazole and the antibiotic Levofloxacin, with three companies involved in each case [3]. Group 2: Regulatory Changes - The NMPA has signaled a tightening of approval standards, as evidenced by the release of draft guidelines addressing major deficiencies in the pharmaceutical research of chemical generics and bioequivalence studies [7][8]. - The new guidelines indicate that applications with significant deficiencies will not be allowed to supplement their materials, leading to more rejections based on existing documentation [8]. Group 3: Market Dynamics - The approval tightening comes amid a backdrop of increasing competition in the generic drug market, with over 60 companies previously obtaining approvals for common drugs like Amlodipine Besylate [5][10]. - The Chinese generic drug market is characterized by a high level of competition, with a significant increase in the number of similar products, leading to market saturation and reduced profitability for generic manufacturers [10][11]. - The market share of chemical generics is projected to remain at 50% in 2024, with a notable increase in the number of products evaluated or deemed equivalent, rising from 543 in 2021 to 914 in 2024 [10].