Core Viewpoint - The National Medical Products Administration (NMPA) has announced a new policy to expedite the clinical trial approval process for innovative drugs, reducing the review time to 30 working days, which represents a 50% acceleration in the approval process [1][2]. Group 1: Policy Changes and Impacts - The new policy aims to prioritize resources for innovative drugs that have significant clinical value, ensuring that only those meeting specific criteria can access the expedited review process [2][4]. - In 2024, the NMPA approved 48 Class 1 innovative drugs, a 20% increase year-on-year, marking the highest number in five years, with over 70% of these approvals achieved through accelerated pathways [2][3]. - The approval of 39 global new drugs in China from January to May 2024, with 34 being domestic innovations, highlights the vibrant growth of China's pharmaceutical innovation [3]. Group 2: Historical Context and Future Outlook - Prior to 2015, the domestic pharmaceutical market primarily followed a model of imitative innovation, with new drugs typically taking 5-7 years longer to launch in China compared to overseas [4]. - The establishment of rapid review channels and the acceleration of key national research projects are expected to enhance China's competitiveness in global pharmaceutical innovation [4][5]. - The recent establishment of review centers in regions like the Yangtze River Delta and the Greater Bay Area aims to improve regulatory efficiency and support the rapid approval of innovative drugs [5]. Group 3: Global Trends - The FDA has also introduced a new priority review program, reducing its approval timeline from approximately 10-12 months to 1-2 months, indicating a global trend towards faster clinical review processes [5].

6月3日，君实生物今日收盘33.06元，上涨1.69%，最新市净率5.80，创157天以来新低，总市值325.87亿 元。 截至2025年一季报，共有15家机构持仓君实生物，其中基金12家、其他3家，合计持股数18508.72万 股，持股市值55.71亿元。 上海君实生物医药科技股份有限公司的主营业务是新药的研发及相关技术的转让和服务，新药的生产和 销售。公司的主要产品是特瑞普利单抗、氢溴酸氘瑞米德韦片、Tifcemalimab、阿达木单抗、昂戈瑞西 单抗、重组人源化抗IL-17A单克隆抗体、重组人源化抗PD-1、VEGF双特异性抗体、靶向 ANGPTL3mRNA的siRNA药物、重组人源化抗CGRP单克隆抗体、PI3K-α抑制剂、重组人源化抗 Claudin18.2单抗-MMAE偶联剂。公司拥有175项已授权专利，其中129项为境内专利，46项为境外专 利。公司专利覆盖新药蛋白结构、制备工艺、用途、制剂配方等，为公司产品提供充分的和长生命周期 的专利保护。 序号股票简称PE(TTM)PE(静)市净率总市值(元)20君实生物-26.43-25.445.80325.87亿行业平均 64.6353.7310.39 ...

上海君实生物医药科技股份有限公司的主营业务是新药的研发及相关技术的转让和服务，新药的生产和 销售。公司的主要产品是特瑞普利单抗、氢溴酸氘瑞米德韦片、Tifcemalimab、阿达木单抗、昂戈瑞西 单抗、重组人源化抗IL-17A单克隆抗体、重组人源化抗PD-1、VEGF双特异性抗体、靶向 ANGPTL3mRNA的siRNA药物、重组人源化抗CGRP单克隆抗体、PI3K-α抑制剂、重组人源化抗 Claudin18.2单抗-MMAE偶联剂。公司拥有175项已授权专利，其中129项为境内专利，46项为境外专 利。公司专利覆盖新药蛋白结构、制备工艺、用途、制剂配方等，为公司产品提供充分的和长生命周期 的专利保护。 最新一期业绩显示，2024年年报，公司实现营业收入19.48亿元，同比29.67%；净利润-1280926434.36 元，同比43.90%，销售毛利率78.92%。 4月21日，君实生物今日收盘29.46元，上涨2.65%，最新市净率4.96，总市值290.38亿元。 股东方面，截至2025年2月28日，君实生物股东户数29351户，较上次增加260户，户均持股市值35.28万 元，户均持股数量2.76万股 ...