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“国谈”价格保密进入第七年,引入创新药目录后将有哪些变化
Di Yi Cai Jing· 2025-08-05 12:21
"就在不久之前,香港卫生署给我们发来邮件,希望引入我们的一款CAR-T(嵌合抗原受体T细胞免疫 疗法)产品,对当地药品目录进行优化。相较于该区域市场上的另一款CAR-T产品,我们产品定价相当 于打了对折,单价低了100多万港币。" 张妍(化名)是国内某头部CAR-T企业市场准入相关负责人。谈及这次邀约时,她表示,一方面,企业 对于"打开境外市场销路"乐见其成;但另一方面,企业也存在一层担忧:考虑到医保支付端的承受能 力、患者可及性及市场竞争现况,CAR-T疗法在境内市场已给出了较低的定价,但企业在全球市场的投 入回报率可能因国际比价和价格联动而变得不确定。 "百万抗癌药"CAR-T药品所面临的商业化困境具有一定的典型性。整体来看,我国目前创新药价格在全 球范围内属较低水平,同一款药国内外销售价格相差二三十倍的案例屡有发生,一定程度制约了我国创 新药生态链发展。 业界担忧的还有两个趋势:一些本土创新药企将销售重心转向海外市场或将早期成果"卖青苗"出售;一 些跨国药企在考虑到全球价格体系后,可能对中国市场的产品引入和销售预期进行调整。长期来看,这 两个趋势可能会影响到中国创新药产业的国际竞争优势和国内患者获益。 ...
医药生物行业双周报2025 年第16 期总第139期:上半年中国创新药BD交易总额突破600亿美元,关注真创新平台化国际化企业-20250805
Great Wall Glory Securities· 2025-08-05 08:47
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]
新药周观点:25Q2创新药板块持仓环比仍保持大幅提升-20250803
Guotou Securities· 2025-08-03 09:02
Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [4] Core Insights - The innovative drug sector has seen a significant increase in institutional interest, with the total heavy positions in Biotech innovative drugs reaching 80.371 billion yuan, a quarter-on-quarter growth of 39% [7][18] - The proportion of heavy positions in Biotech innovative drugs relative to the overall market has increased to 2.39%, up by 0.49 percentage points, indicating sustained enthusiasm from institutions towards the innovative drug sector [19][25] - The heavy positions in Biotech innovative drugs account for 24.93% of the total heavy positions in the pharmaceutical industry, reflecting a rise of 5.49 percentage points [19][25] Summary by Sections Weekly Review of New Drug Market - From July 28 to August 1, 2025, the top five companies in the new drug sector by stock price increase were: Zhongsheng Pharmaceutical (29.53%), WuXi AppTec (17.72%), CSPC Pharmaceutical Group (14.60%), Maiwei Biotech (12.08%), and Haizhi Pharmaceutical (11.76%) [14][15] - The top five companies by stock price decrease were: Kintor Pharmaceutical (-19.09%), Hualing Pharmaceutical (-16.19%), Junsheng Pharmaceutical (-13.24%), Kintor Pharma (-12.70%), and Yunding New Drug (-11.29%) [14][15] Key Analysis of New Drug Industry - The report analyzed the latest heavy positions of all funds in the innovative drug sector as of June 30, 2025, focusing on A-share and Hong Kong Biotech companies [18] - The heavy positions in Biotech innovative drugs accounted for 7.05% of the total market capitalization, an increase of 0.93 percentage points [23][28] New Drug Approval and Acceptance - This week, 13 new drug or new indication applications were approved, including drugs such as Risperidone orally disintegrating film and Nivolumab injection [33][34] - Additionally, 6 new drug or new indication applications were accepted, including drugs like Eptinezumab injection and Edaravone tablets [35][36] Clinical Application Approval and Acceptance - A total of 50 new drug clinical applications were approved this week, while 44 new drug clinical applications were accepted [37]