仿制药发展2.0阶段：“过评”数量大增，同质化加剧

Core Insights - The Chinese generic drug market is experiencing intensified competition due to increased homogeneity of products and cost-cutting production strategies driven by the "volume-based procurement" policy [1][2][3] Market Overview - The Chinese generic drug market has maintained a scale of approximately 900 billion yuan, with an increase in the number of companies and products intensifying competition [1] - As of 2024, the number of generic drugs that have passed consistency evaluation or are deemed equivalent has increased by over two-thirds compared to three years ago, primarily driven by a few companies and previously approved products [1][3] Product Evaluation and Approval - By 2024, the number of approved or equivalent generic drug varieties reached 914, a significant increase from 543 in 2021, with 70% of these concentrated in 33% of companies [5][8] - The concentration of approved products remains low, with the top 10 companies holding about 22% of the market share in the chemical generic drug sector [3][5] Biological Similarity Drugs - As of 2024, 87 biological similar drugs have been approved in China, with over 50% being antibody similar drugs [8] - The application for metabolic drugs, particularly semaglutide, has surged, indicating a trend towards increased competition in this segment [8] Regulatory Environment - The National Medical Products Administration (NMPA) has released 93 batches of reference preparation directories since 2017, covering 2,787 varieties, but the coverage of domestic innovative drugs remains low [9] - The NMPA is implementing a dynamic adjustment mechanism for the reference preparation directory to better meet public medication needs [9] Contract Manufacturing Trends - The participation of contract manufacturers in national drug procurement has significantly increased, with 31% of selected products in the tenth batch being produced by contract enterprises, up from 3% in the second batch [10][13] - The regulatory focus is shifting towards ensuring quality in contract manufacturing, with increased scrutiny on compliance and quality management systems [13][14]