药品试验数据保护
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国家药监局:助力创新药“中国首发”
Xin Hua Wang· 2026-01-07 10:47
Core Insights - China is enhancing support for innovative drugs with new mechanisms and targets across the entire chain of communication, clinical trials, registration, and review processes to facilitate "China's first launch" of innovative drugs [1][2] - By 2025, there is an expectation for a significant increase in the market launch of urgently needed clinical products in the pharmaceutical and medical device sectors [1] Group 1: Pharmaceutical Sector - In 2022, the National Medical Products Administration (NMPA) approved a total of 4,087 drug registration applications, including 76 innovative drugs, marking a historical high [1] - The time gap for domestic and international drug listings has been reduced, with 59 foreign new drugs receiving temporary import approval [1] - A total of 138 children's drugs were approved, and 48 rare disease drugs were granted temporary import approval, addressing medication gaps for special populations [1] Group 2: Medical Device Sector - The NMPA approved 3,402 medical device products in 2022, including 76 innovative medical devices, achieving a new record [1] - The medical device innovation ecosystem is continuously improving, supporting industry upgrades [1][2] - In 2026, the NMPA plans to expedite the market launch of high-end medical devices and allocate more review resources to urgently needed innovative devices and those for rare disease prevention [2] Group 3: Future Initiatives - The NMPA will implement a drug trial data protection system and establish market exclusivity for children's and rare disease medications [2] - There will be a focus on optimizing the review and approval measures for cell and gene therapy drugs [2] - The establishment of a national standardized technical working group for intelligent frontier medical devices is planned to advance standard formulation in key areas such as brain-machine interfaces [2]
港药又冲高,康方生物涨超6%,再赢头对头临床研究!可T+0交易的恒生生物科技ETF(513280)涨超2%,冲击5连涨
Sou Hu Cai Jing· 2025-04-24 02:18
截至2025年4月24日 09:56,恒生生物科技指数(HSHKBIO)强势上涨2.65%,成分股荣昌生物(09995)上涨11.47%,亚盛医药-B(06855)上涨8.46%,信达生物 (01801)上涨7.68%,康方生物(09926),科伦博泰生物-B(06990)等个股跟涨。恒生生物科技ETF(513280)上涨2.62%, 冲击5连涨。最新价报0.9元。拉长时间 看,截至2025年4月23日,恒生生物科技ETF近1周累计上涨8.79%,涨幅排名可比基金1/3。 流动性方面,恒生生物科技ETF盘中换手13.76%,成交3643.04万元,市场交投活跃。拉长时间看,截至4月23日,恒生生物科技ETF近1月日均成交8279.67 万元。 份额方面,恒生生物科技ETF近1月份额增长700.00万份,实现显著增长,新增份额位居可比基金1/3。 国信证券此前指出,建议关注出海加速的创新药以及政策支持的服务板块。从2025年初以来,国产创新药企业已经完成了几十笔对外授权的交易。国产创新 药的研发进度和临床数据越来越在全球范围内占到优势,创新药BD出海受关税影响较小,有望继续通过授权出海的形式实现全球的商业化价值 ...