新药周观点：2025年约101款创新药国内获批上市，行业蓬勃发展-20260104

Investment Rating - The report indicates a positive outlook for the biopharmaceutical industry, highlighting the approval of approximately 101 innovative drugs in 2025, marking a significant growth in the sector [3]. Core Insights - The innovative drug sector in China is experiencing robust growth, with 63 domestic innovative drugs (62% of total approvals) and 38 imported innovative drugs (38% of total approvals) approved in 2025 [3]. - The report suggests several companies to watch, including those with high certainty for overseas expansion and those with potential overseas data catalysts [2][20]. - The report emphasizes the importance of upcoming catalysts such as academic conferences and data releases that could impact the sector positively [2]. Summary by Sections Weekly New Drug Market Review - From December 29, 2025, to January 4, 2026, the top five gainers in the new drug sector were Youzhiyou (+12.45%), Aidi Pharmaceutical (+8.07%), Yongtai Biological (+6.72%), Kaituo Pharmaceutical (+6.25%), and Yahong Pharmaceutical (+4.07%). The top five losers were Jakes (+-15.53%), Yunding Xinyao (-15.06%), Kedi (-11.73%), Gelei Pharmaceutical (-8.64%), and Kangning Jere (-8.06%) [1][16]. Weekly Focused Stocks - The report recommends focusing on companies with MNC certification and high certainty for overseas volume, such as Sanofi Pharmaceutical, Lianbang Pharmaceutical, and Kelun Biotech. It also highlights companies with potential overseas data catalysts like Betta Pharmaceuticals and Hengrui Medicine [2][20]. Weekly New Drug Industry Analysis - The report notes that 2025 saw a record high in the number of approved innovative drugs in China, with a total of approximately 101 drugs approved by NMPA, excluding new indications, modified new drugs, biosimilars, traditional Chinese medicine, and vaccines [3][21]. Weekly New Drug Application Approval & Acceptance - No new drug or new indication applications were approved this week, but four new drug or new indication applications were accepted [4][27]. Weekly New Drug Clinical Application Approval & Acceptance - This week, 18 new drug clinical applications were approved, and 52 new drug clinical applications were accepted [5][30].