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产业深观察|中国创新药的全球竞争力到底有多强?
新华网财经· 2025-08-14 02:26
Core Viewpoint - The article highlights the rapid growth and transformation of China's innovative drug development sector, emphasizing its shift from quantity to quality and its increasing global competitiveness [2][8][20]. Summary by Sections Innovative Drug Approvals - In the first half of 2025, China approved 43 innovative drugs, a 59% increase year-on-year, nearing the total of 48 approvals in 2024 [2]. - The innovative drug sector is benefiting from favorable policies that support the entire industry chain, showcasing China's growing global competitiveness in biopharmaceuticals [2]. Clinical Development and Regulatory Efficiency - The average time for innovative drug approval has decreased from 420 working days in 2017 to 235 days [5]. - Measures have been implemented to improve access to rare disease medications, with several rare disease drugs approved in the first half of 2025 [5][7]. Shift in Drug Development Focus - Chinese innovative drug development is transitioning from "Me-too" drugs to "Best-in-class" drugs, with a focus on unmet clinical needs [8]. - The industry is enhancing its research capabilities and internationalization, with a notable increase in original innovations [8][20]. International Collaboration and Market Expansion - Chinese companies are exploring various models for international recognition, including licensing, joint development, and independent market entry [10][12]. - Notable collaborations include agreements between companies like 3SBio and Pfizer, and Heng Rui Pharma with GSK, aimed at accelerating drug development and market entry [11][12]. Global Registration and Recognition - Chinese innovative drugs are achieving global recognition, with products like Zepzelca and others gaining approval in major markets [16]. - Companies are focusing on high-quality clinical research and compliance with international standards to enhance their global competitiveness [18][19]. Challenges and Future Directions - Despite progress, challenges remain in areas such as platform technology accumulation and global commercialization experience [23]. - The industry needs to enhance its capabilities in original innovation and market access strategies to improve the commercialization of new drugs [23][24]. Policy Support and Industry Development - The government is actively supporting true innovation and differentiated innovation through various policies [21][24]. - Future industry development requires collaboration across multiple sectors, including regulatory improvements and talent development [24][25].
上海复星医药(集团)股份有限公司关于控股子公司获药品注册申请受理的公告
Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Jisimei (Wuhan) Pharmaceutical Co., Ltd., has received acceptance for the drug registration application of injection Nadir platinum by the National Medical Products Administration [2][4]. Drug Information and Research Status - The drug is a self-developed chemical product by the group, intended for the treatment of head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer, bladder cancer, testicular cancer, ovarian cancer, and cervical cancer [3]. - As of July 2025, the cumulative R&D investment for this drug is approximately RMB 5.66 million (unaudited) [4]. - According to the latest IQVIA CHPA data, the projected sales for injection Nadir platinum in mainland China (excluding Hong Kong, Macau, and Taiwan) for 2024 is approximately RMB 353 million [4].
复星医药控股子公司注射用奈达铂获药品注册申请受理
Bei Jing Shang Bao· 2025-08-12 14:23
Core Viewpoint - Fosun Pharma's subsidiary, Gismed (Wuhan) Pharmaceutical Co., Ltd., has received acceptance from the National Medical Products Administration for the drug registration application of injectable Nedaplatin, which is a self-developed chemical drug intended for various cancers [1] Group 1 - The drug Nedaplatin is designed for the treatment of head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer, bladder cancer, testicular tumors, ovarian cancer, and cervical cancer [1]
复星医药:关于控股子公司获药品注册申请受理的公告
Zheng Quan Ri Bao· 2025-08-12 13:17
Group 1 - The core point of the article is that Fosun Pharma announced the acceptance of its subsidiary's drug registration application for injection of Nedaplatin by the National Medical Products Administration [2] Group 2 - The announcement was made on the evening of August 12 [2] - The subsidiary involved is Gismed (Wuhan) Pharmaceutical Co., Ltd. [2] - The drug in question is Nedaplatin, which is used for injection [2]
复星医药:2024年公司通过处置资产回笼金额超过20亿元人民币
Mei Ri Jing Ji Xin Wen· 2025-08-12 11:12
Core Viewpoint - The company is focusing on divesting non-core businesses and optimizing its asset structure to enhance cash flow, with plans to recover over 2 billion RMB through asset disposals in 2024 [2]. Group 1: Non-Core Business Strategy - The company plans to exit non-core businesses, which will be determined by market conditions and business planning to ensure strategic focus and shareholder interests [2]. - The scale of the non-core investments and the timeline for exiting these investments have not been specified, indicating a flexible approach based on various factors [2]. Group 2: Strategic Investment - The strategic investment by Fosun Health in Foshan Zhanxi City Investment is still in progress, with both parties actively working on the implementation [2].
复星医药(02196.HK)子公司注射用奈达铂注册申请获受理 瞄准头颈癌等大癌种
Ge Long Hui· 2025-08-12 09:33
Core Viewpoint - Fosun Pharma's subsidiary, Jisimei (Wuhan) Pharmaceutical Co., Ltd., has received acceptance for the drug registration application of injectable Nedaplatin by the National Medical Products Administration, indicating progress in the company's drug development pipeline [1]. Group 1 - The drug Nedaplatin is a self-developed chemical medication by the group [1]. - It is intended for the treatment of various cancers, including head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer, bladder cancer, testicular cancer, ovarian cancer, and cervical cancer [1].
复星医药:注射用奈达铂的药品注册申请获国家药监局受理
Zhi Tong Cai Jing· 2025-08-12 09:32
Core Viewpoint - Fosun Pharma's subsidiary, Jisimei (Wuhan) Pharmaceutical Co., Ltd., has received acceptance from the National Medical Products Administration for the drug registration application of injectable Nedaplatin, which is a self-developed chemical drug intended for various cancers [1] Group 1 - The drug is designed for the treatment of head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer, bladder cancer, testicular tumors, ovarian cancer, and cervical cancer [1] - As of July 2025, the total R&D investment for this drug is approximately RMB 5.66 million (unaudited) [1]
复星医药(02196):注射用奈达铂的药品注册申请获国家药监局受理
智通财经网· 2025-08-12 09:29
Core Viewpoint - Fosun Pharma's subsidiary, Gismed (Wuhan) Pharmaceutical Co., Ltd., has received acceptance for the drug registration application of injectable Nedaplatin from the National Medical Products Administration, indicating progress in the company's drug development pipeline [1] Group 1: Drug Development - The drug Nedaplatin is a self-developed chemical drug by the group, intended for the treatment of various cancers including head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer, bladder cancer, testicular tumor, ovarian cancer, and cervical cancer [1] - As of July 2025, the cumulative R&D investment for this drug is approximately RMB 5.66 million (unaudited) [1]
复星医药(02196) - 海外监管公告 - 关於控股子公司获药品註册申请受理的公告
2025-08-12 09:20
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整性亦不 發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚賴該等內容而引致的任何損 失承擔任何責任。 上 海 復 星 醫 藥( 集 團 )股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (於中華人民共和國註冊成立的股份有限公司) (股份代號:02196) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出。 茲載列上海復星醫藥(集團)股份有限公司(「本公司」)在上海證券交易所網站刊登的《關於 控股子公司獲藥品註冊申請受理的公告》,僅供參閱。 承董事會命 上海復星醫藥(集團)股份有限公司 董事長 陳玉卿 中國,上海 2025 年8 月1 2 日 於本公告日期,本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生及王可心先生;本公司之非執行 董事為陳啟宇先生、潘東輝先生及吳以芳先生;本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生及楊玉成先生;以及本公司之職工董事為嚴佳女士。 ...
复星医药: 复星医药关于控股子公司获药品注册申请受理的公告
Zheng Quan Zhi Xing· 2025-08-12 09:10
一、概况 近日,上海复星医药(集团)股份有限公司(以下简称"本公司")控股子公 司吉斯美(武汉)制药有限公司就注射用奈达铂(以下简称"该药品")的药品注 册申请获国家药品监督管理局受理。 二、该药品的基本信息及研究情况 证券代码:600196 股票简称:复星医药 编号:临 2025-127 上海复星医药(集团)股份有限公司 关于控股子公司获药品注册申请受理的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 该药品为本集团(即本公司及控股子公司/单位,下同)自主研发的化学药品, 拟用于头颈部癌、小细胞肺癌、非小细胞肺癌、食管癌、膀胱癌、精巢(睾丸) 肿 瘤、卵巢癌、宫颈癌。 截至 2025 年 7 月,本集团现阶段针对该药品的累计研发投入约为人民币 566 万 元(未经审计)。 董事会 由 IQVIA 提供,IQVIA 是全球医药健康产业专业信息和战略咨询服务提供商;IQVIA CHPA 数据代 表中国境 内 100 张床位以上的医院药品销售市场,不同的药品因其各自销售渠道布局的不同,实际销售情况可 能与 IQVIA CHP ...