氢溴酸氘瑞米德韦片
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创新药临床试验审批迈入“30日时代”,药企研发迎来“及时雨”|创新药观察
Hua Xia Shi Bao· 2025-06-19 06:49
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].
君实生物收盘上涨1.69%,最新市净率5.80,总市值325.87亿元
Jin Rong Jie· 2025-06-03 10:54
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 ...
君实生物收盘上涨2.65%,最新市净率4.96,总市值290.38亿元
Jin Rong Jie· 2025-04-21 11:56
Company Overview - Junshi Biosciences closed at 29.46 yuan, up 2.65%, with a latest price-to-book ratio of 4.96 and a total market capitalization of 29.038 billion yuan [1] - As of February 28, 2025, Junshi Biosciences had 29,351 shareholders, an increase of 260 from the previous count, with an average holding value of 352,800 yuan and an average holding quantity of 27,600 shares [1] Business Operations - The main business of Junshi Biosciences includes the research and development of new drugs, technology transfer, and related services, as well as the production and sales of new drugs [1] - Key products include Toripalimab, Dihydrocodeine Bromide Tablets, Tifcemalimab, Adalimumab, Oncorhynchus mykiss monoclonal antibody, and various other monoclonal antibodies and inhibitors [1] - The company holds 175 authorized patents, with 129 domestic patents and 46 international patents, covering drug protein structures, preparation processes, uses, and formulation recipes, providing long-term patent protection for its products [1] Financial Performance - In the latest financial report for 2024, Junshi Biosciences achieved operating revenue of 1.948 billion yuan, a year-on-year increase of 29.67%, while net profit was -1.281 billion yuan, a year-on-year decrease of 43.90%, with a gross profit margin of 78.92% [1] Industry Comparison - Junshi Biosciences has a TTM PE ratio of -22.67 and a static PE ratio of -22.67, with a market capitalization of 29.038 billion yuan [2] - The industry average PE ratio is 44.27 (TTM) and 43.79 (static), with an average market capitalization of 18.383 billion yuan [2] - The industry median PE ratio is 38.38 (TTM) and 33.06 (static), with a median market capitalization of 7.437 billion yuan [2]