"以前等临床试验批件要几个月，现在最快30天就有希望拿到，这对我们做创新药研发的来说，简直是'及时 雨'。"一位国内创新药企的研发负责人在得知其项目被纳入国家药监局试点后对《华夏时报》记者感慨道。 近日，国家药监局发布《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》（下称《意 见》），其中特别提到，为进一步支持以临床价值为导向的创新药研发，提高临床研发质效，对符合要求的创新 药临床试验申请在30个工作日内完成审评审批。 审批提速50%，既能显著缩短新药研发的"起跑"时间，又体现了国家医药政策对于创新药行业一以贯之的支持力 度。那么，哪些创新药企将因此受益，审批提速后政策东风还将带来哪些深远影响？ 精准提速：审评"高速口"为谁而开 显然，药监局的提速并非"大水漫灌"，而是力求"精准滴灌"，确保宝贵的审评资源优先服务于最急需、最具价值 的创新。 谁能驶入这条"快车道"？《意见》稿中设定了明确且严格的门槛。 "设定这些条件，核心目的是引导资源向真正有临床价值、企业有高效执行力的项目倾斜。"上述研发负责人强 调，"行业需要的不仅是审评环节的速度，更是整个创新药更早惠及患者的'总速度'。" 随着近年来药审 ...

Core Viewpoint - The recent surge in the Hong Kong innovative drug sector, particularly for Xiansheng Pharmaceutical, is driven by favorable factors such as the cyclical resurgence of COVID-19 and record-breaking domestic innovative drug business development (BD) deals [1] Group 1: Stock Performance - Xiansheng Pharmaceutical's stock price has experienced a continuous rise since May 16, achieving a maximum increase of 28.33% by May 21, with a cumulative increase of nearly 50% year-to-date [1] - The stock has shown significant trading activity, with over 25 million shares traded on three consecutive days from May 19 to 21, indicating strong market interest [4] Group 2: Business Development Potential - The recent $60.5 billion BD deal between Innovent Biologics and Pfizer has spotlighted the potential of Chinese innovative drugs, with Xiansheng Pharmaceutical being a key player in this growth [2] - Xiansheng Pharmaceutical has developed multiple ADC (antibody-drug conjugate) candidates targeting various biomarkers, with products like SCR-A006 showing Best-in-Class potential [2] Group 3: International Expansion - Xiansheng Pharmaceutical has established a track record in international markets, with its first overseas deal for SIM0278 setting a record for domestic autoimmune drug BD at the time [3] - The company has secured a licensing agreement exceeding $1 billion for SIM0500 with AbbVie, currently undergoing clinical trials in the U.S. and China [3] Group 4: Innovation and R&D - The company has invested over 8.5 billion yuan in R&D over six years, developing over 60 innovative drug candidates across various therapeutic areas [5] - Three new drug molecules are in the NDA approval process, while four are in Phase III clinical trials, indicating a robust pipeline [5] - The anticipated launch of significant new drugs will further enhance the company's position in the global biopharmaceutical market [5]

宜明昂科-B(01541)涨超10%，与Axion Bio合作近期再获500万美元付款，IMM0306自免领域前景广阔。 基石药业-B(02616)涨超18%，近期在2025 AACR大会发布五项最新研究成果。 荣昌生物(09995)再涨超14%，维迪西妥单抗新增适应症，一季度业绩略超预期。 顺丰同城(09699)再涨超5%，即时消费市场竞争加剧，第三方即时配送平台有望显著受益。 智通财经APP获悉，港股恒生指数涨1.29%，涨301点，报23634点；恒生科技指数涨1.32%；恒生生物科 技指数大涨4.26%。港股早盘成交1211亿港元。 宁德时代(03750)港交所挂牌首日，上午大涨超16%。 三生制药(01530)暴涨35%逼近历史前高，公司与辉瑞就PD-1/VEGF双抗达成授权协议。辉瑞将支付12.5 亿美元不可退还且不可抵扣的首付款，最高可达48亿美元的开发、监管批准和销售里程碑付款，以及根 据授权地区产品销售额计算得到的两位数百分比的梯度销售分成。 先声药业(02096)再涨5.4%，先诺欣5月以来销量大幅增长，后续多款新药获批在望。 布鲁可(00325)涨超2%创上市新高，公司有望6月进入港股通 ...

Core Viewpoint - The sales of the COVID-19 drug Xianoxin from Xiansheng Pharmaceutical have significantly increased since May, with notable growth in both year-on-year and month-on-month comparisons, although specific figures have not been disclosed [1] Sales Performance - Sales growth in early April was primarily driven by regions such as Shanghai, Zhejiang, Beijing, and Jiangsu [1] - Sales in Guangdong began to rise in early May, contributing to a substantial overall increase in sales since then [1] - As of now, Xianoxin has reached 32 provinces, 371 cities, and over 3,700 medical institutions across the country [1] Market Context - The latest report from the Chinese Center for Disease Control and Prevention indicates an upward trend in the positive rate of COVID-19 tests from March 31 to May 4, with southern provinces showing higher positivity rates compared to northern provinces [1] - Some provinces that experienced an early increase in positivity rates are seeing a slowdown in the growth of the epidemic [1]

康宁杰瑞制药-B(09966)再涨超6%，与石药合作开发KN026达PFS主要终点。 巨星传奇(06683)再涨超12%，《周游记3》开播爆火，公司IP业务收入贡献首次多于新零售业务。 古茗(01364)涨超3%，获纳入恒生综合指数，中金看好其二季度同店增速保持同比高位。 艾美疫苗(06660)涨超9%，中美双报迭代mRNA带状疱疹疫苗均获批开展临床。 智通财经APP获悉，港股恒生指数跌0.49%，跌114点；恒生科技指数跌1.03%。港股早盘成交1055亿港 元。 英伟达首席执行官黄仁勋表示，由于美国政府限制Hopper架构的H20芯片出口至中国，公司正重新审视 中国市场战略，但未来不会再推出Hopper系列芯片。半导体股逆市上扬，华虹半导体(01347)涨超4%， 中芯国际(00981)涨超1.8%。 阜博集团(03738)涨超4%，《数字中国建设2025年行动方案》发布，公司布局AI领域服务。 四环医药(00460)涨超16%，旗下吡洛西利片两个适应症获药品注册批件。 先声药业(02096)涨超7%，新冠抬头引发关注，先诺欣为国内首款获得常规批准的新冠口服药。 阿里巴巴-W(09988)续跌超4%，第四 ...