2025年落下帷幕，医药行业这一年可谓波澜壮阔。仿制药领域更是风起云涌。既有集采价格战的激烈厮杀，又有监管"风暴"的强力洗礼，而首仿药的争夺 战，更是成为这场行业大戏中的核心看点。 这足以证明，即便在严苛环境下，首仿药市场依然释放着强大吸引力。 这不仅仅是数量的竞争，更是研发速度、立项眼光和注册策略的综合比拼。首仿药，已成为衡量药企仿制药研发实力的核心指标之一。 二、科伦再首仿王座，齐鲁制药紧随其后 2025年的首仿排行榜，呈现"一超多强，新老交替"的格局。 在国内首仿药领域，齐鲁、科伦、恒瑞医药、石药集团为头部企业。科伦药业展现出持续的领跑优势。2022年与恒瑞均以7款首仿并列榜首，2023年以6款首 仿位居榜首。尽管2024年首仿获批数量有所回调，但仍成功斩获4款首仿药。2025年，科伦再度以6款首仿强势回归榜首，进一步巩固其龙头地位。 一、集采深水区，首仿药成"避风港" 第十一批国家药品集采围绕"稳临床、保质量、反内卷、防围标"系统优化规则，堪称行业分水岭。此次集采品种多，且首次纳入胰岛素专项、生物类似药及 中成药大品种，降价压力从化学药延伸至更多治疗领域。 在常规仿制药进入"微利时代"的背景下，首仿药 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 4.90%, ranking third among 31 primary industries, outperforming the CSI 300 index, which decreased by 0.09% [4][15] - The sub-industries of medical research outsourcing and vaccines saw significant gains of 12.70% and 6.59%, respectively, while blood products and offline pharmacies lagged with increases of only 0.35% and 2.41% [4][15] - As of August 1, 2025, the overall PE (TTM) for the pharmaceutical and biotechnology industry was 30.97x, up from 30.09x in the previous period, indicating an upward valuation trend [4][21] - The top three sub-industries by PE (TTM) are vaccines (62.06x), hospitals (38.94x), and other biological products (38.44x), while the lowest valuation is in pharmaceutical circulation (16.12x) [4][21] Industry Review - The National Medical Products Administration (NMPA) is seeking public opinion on the "Regulations on the Filing Management of Internet Drug and Medical Device Information Services" [6] - The State Council's news office held a press conference discussing multiple measures for drug price management [6] - Bristol-Myers Squibb's "Nivolumab Injection" combined with "Ipilimumab Injection" received NMPA approval, marking it as China's first approved dual immune therapy for lung cancer [6] - The total transaction amount for innovative drug BD in China exceeded 60 billion USD in the first half of 2025, indicating a significant market shift towards platform-based pipeline output [7] Investment Recommendations - The National Healthcare Security Administration (NHSA) has clarified a "reverse inward competition" direction in the 11th batch of centralized procurement, promoting a shift from price competition to a quality-first and reasonably priced ecosystem [7] - The report suggests focusing on companies with "true innovation" capabilities, strong barriers (complex formulations/high-end device domestic replacements), platform-based operations, and internationalization [7]