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复星医药(600196) - 复星医药关于控股子公司药品临床试验进展的公告

2025-07-09 08:45
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。 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 司上海复星医药产业发展有限公司就复迈宁®(通用名:芦沃美替尼片,以下简称"该 药品")用于治疗儿童低级别脑胶质瘤于中国境内(不包括港澳台地区,下同)启 动Ⅲ期临床试验。 二、该药品的基本信息及研究情况 该药品为本集团(即本公司及控股子公司/单位,下同)自主研发的创新型小分 子化学药物,为 MEK1/2 选择性抑制剂。截至本公告日期(即 2025 年 7 月 9 日), 该药品的临床或注册情况如下: 证券代码:600196 股票简称:复星医药 编号:临 2025-115 上海复星医药(集团)股份有限公司 关于控股子公司药品临床试验进展的公告 三、风险提示 根据研发经验,药品研发存在一定风险,例如临床试验可能会因为安全性和/ 或有效性等问题而终止。 药品研发及至上市是一项长期工作,存在诸多不确定因素,敬请广大投资者注 意投资风险。 特此公告。 1、该药品已于中国境内上市并获批两项适应症,包括用于治疗(1) ...
复星医药:控股子公司药品芦沃美替尼片中国境内启动Ⅲ期临床试验
news flash· 2025-07-09 08:31
Group 1 - The core point of the article is that Fosun Pharma has initiated a Phase III clinical trial for its drug Luvofematin in China, targeting pediatric low-grade glioma [1] - The drug is a selective inhibitor of MEK1/2 and has already been approved for two indications in China [1] - The total R&D investment for this drug is approximately RMB 607 million, expected to be completed by May 2025 [1] Group 2 - According to IQVIA data, the global sales for MEK1/2 selective inhibitors are projected to reach approximately USD 2.068 billion in 2024 [1]
沪深300制药指数报11609.22点,前十大权重包含百利天恒等
Jin Rong Jie· 2025-07-09 08:11
Group 1 - The core viewpoint of the articles highlights the performance of the CSI 300 Pharmaceutical Index, which closed at 11609.22 points, showing a decline of 2.48% over the past month, an increase of 5.29% over the past three months, and a year-to-date increase of 6.57% [1] - The CSI 300 Pharmaceutical Index is composed of listed companies in the pharmaceutical sector selected from the CSI 300 Index, reflecting the overall performance of these companies [1] - The index was established on December 31, 2004, with a base point of 1000.0 [1] Group 2 - The top ten weighted companies in the CSI 300 Pharmaceutical Index include: Heng Rui Medicine (41.61%), Pian Zai Huang (10.46%), Yunnan Baiyao (8.71%), Kelun Pharmaceutical (6.52%), East China Pharmaceutical (6.0%), New Harmony (5.88%), Fosun Pharmaceutical (5.59%), Tong Ren Tang (4.26%), Bai Li Tian Heng (4.09%), and China Resources Sanjiu (3.63%) [1] - The market segment distribution of the CSI 300 Pharmaceutical Index shows that the Shanghai Stock Exchange accounts for 69.26% and the Shenzhen Stock Exchange accounts for 30.74% [2] - In terms of industry composition, the index sample consists of 63.81% drug formulations, 30.31% traditional Chinese medicine, and 5.88% raw materials [2] Group 3 - The index sample is adjusted every six months, with adjustments implemented on the next trading day after the second Friday of June and December each year [2] - Weight factors are adjusted in accordance with the regular sample adjustments, which occur at the same time [2] - In special circumstances, the index may undergo temporary adjustments, such as when a sample company is delisted or undergoes mergers, acquisitions, or splits [2]
基石药业与Gentili达成欧洲商业化合作;润达医疗回复上交所问询函丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-08 23:22
Group 1 - Tong Ren Tang's Executive Vice President Zhang Chunyou submitted a resignation letter, effective July 8, 2025, due to work adjustments, while remaining as General Manager of Tong Ren Tang Technology [1] - The company stated that Zhang Chunyou's departure will not adversely affect daily operations, indicating limited market impact from this internal personnel adjustment [1] Group 2 - Basestone Pharmaceuticals announced an exclusive strategic partnership with Istituto Gentili for the commercialization of Sugliant in Western Europe and the UK, granting Gentili exclusive rights in 23 countries [2] - Basestone will receive up to $192.5 million in payments, including upfront, registration, and sales milestone payments, along with nearly 50% revenue sharing from net sales in the authorized region [2] - This collaboration enhances Basestone's international market recognition and strengthens investor confidence in future growth [2] Group 3 - Fosun Pharma announced guarantees for its subsidiaries, providing a maximum joint liability guarantee for a financing application not exceeding 500 million yuan with Bank of China [3] - Additionally, a guarantee was provided for a financing contract not exceeding 150 million yuan with China Construction Bank for its subsidiary Hanlin Pharmaceutical [3] - This move supports subsidiaries in obtaining funds for business expansion or R&D, although it introduces certain financial risks [3] Group 4 - Run Da Medical responded to the Shanghai Stock Exchange's inquiry regarding its 2024 annual report, addressing issues related to operating performance, goodwill, short-term solvency, and prepayments [4] - The response aims to alleviate market concerns and stabilize investor confidence, although ongoing monitoring of the company's performance improvement measures is necessary [4] Group 5 - Yuan Da Pharmaceutical announced that its joint venture Sirtex Medical Pty Ltd received FDA approval for SIR-Spheres Yttrium-90 microspheres for treating unresectable hepatocellular carcinoma (HCC) [5] - This product is the first and only FDA-approved selective internal radiation therapy for both unresectable HCC and colorectal cancer liver metastases [5] - This breakthrough enhances Yuan Da's market position in oncology and boosts investor confidence in future growth [5]
复星医药(02196) - 海外监管公告 - 关於為控股子公司提供担保的进展公告

2025-07-08 10:04
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 董事長 陳玉卿 中國,上海 2025 年7 月8 日 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 為控股子公司提供擔保的進展公告》,僅供參閱。 承董事會命 上海復星醫藥(集團)股份有限公司 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。 * 僅 ...
复星医药(02196) - 海外监管公告 - 关於归还用於暂时补充流动资金的募集资金的公告

2025-07-08 10:00
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。 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 歸還用於暫時補充流動資金的募集資金的公告》,僅供參閱。 承董事會命 上海復星醫藥(集團)股份有限公司 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) 董事長 上海复星医药(集团)股份有限公司 关于归还用于暂时补充流动资金的募集资金的公告 陳玉卿 中國,上海 2025 年7 月8 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 ...
复星医药(600196) - 复星医药关于为控股子公司提供担保的进展公告

2025-07-08 09:45
证券代码:600196 证券简称:复星医药 公告编号:临 2025-114 上海复星医药(集团)股份有限公司 关于为控股子公司提供担保的进展公告 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。 担保对象及基本情况 | | 名称 | 复星医药产业 | | --- | --- | --- | | 被担保方 1 | 本次担保金额 截至 2025 年 7 月 7 日,包 | 人民币 50,000 万元 | | | 括本次担保在内,本集团 实际为其提供的担保余额 | 折合人民币约 964,103 万元 | | | 是否在前期预计额度内 | 是 □否 □不适用:_________ | | | 本次担保是否有反担保 | 被担保方 1 系担保方 1 之全资子公司, 不涉及反担保安排 | | 被担保方 2 | 名称 | 汉霖制药 | | | 本次担保金额 | 人民币 15,000 万元 | | | 截至 2025 年 7 月 7 日,包 括本次担保在内,本集团 实际为其提供的担保余额 | 人民币 126,550 万元 | | | 是否在前期预 ...
复星医药(600196) - 复星医药关于归还用于暂时补充流动资金的募集资金的公告

2025-07-08 09:45
经 2024 年 7 月 9 日召开的上海复星医药(集团)股份有限公司(以下简称"本 公司")第九届董事会第五十四次会议及第九届监事会 2024 年第六次会议审议通过, 同意本公司 2022 年非公开发行 A 股(以下简称"本次发行")的募投项目实施主体 (包括本公司及负责本次发行募投项目实施的控股子公司,以下合称"募投实施主 体")使用合计不超过人民币 41,000 万元的闲置募集资金暂时补充流动资金,使用 期限自董事会审议通过该事项之日(即 2024 年 7 月 9 日)起不超过 12 个月(以下 简称"暂时补流授权")。 截至 2025 年 7 月 7 日,相关募投实施主体已将上述暂时补流授权项下用于暂时 补充流动资金的款项全部归还至相应的募集资金专项账户。本公司亦已将上述归还 情况通知本次发行的保荐机构中国国际金融股份有限公司及其保荐代表人。 特此公告。 上海复星医药(集团)股份有限公司 董事会 证券代码:600196 股票简称:复星医药 编号:临 2025-113 上海复星医药(集团)股份有限公司 关于归还用于暂时补充流动资金的募集资金的公告 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、 ...
罕见病创新药在北京投入临床使用
Cai Jing Wang· 2025-07-08 06:55
Core Viewpoint - Fosun Pharma's self-developed drug, Luwo Meitini tablets, has been officially launched for clinical use, marking it as China's first and only targeted drug approved for both adult Langerhans cell histiocytosis (LCH) and neurofibromatosis type 1 (NF1) in children aged 2 and above, providing new treatment options for rare disease patients [1][2]. Group 1: Drug Approval and Clinical Use - Luwo Meitini tablets received approval from the National Medical Products Administration (NMPA) on May 29 and were put into clinical use in Beijing and other cities within a month, addressing the dual challenges of "no available drugs" and "difficult access to drugs" for rare disease patients [1]. - The drug is expected to significantly improve drug accessibility for patients suffering from rare diseases, filling a treatment gap in the domestic market [1]. Group 2: Impact on NF1 Patients - NF1 is a rare genetic disorder that can severely impact patients' quality of life, with surgical interventions often limited in effectiveness [2]. - Luwo Meitini tablets are the first targeted drug approved for NF1 in China, showing promising clinical data with good efficacy and controllable safety, offering new hope for patients who cannot undergo surgery or have unsatisfactory surgical outcomes [2][3]. Group 3: Clinical Data and Efficacy - Luwo Meitini is a novel small molecule targeted drug that inhibits MEK1/2 protein activity, blocking the abnormal activation of the MAPK signaling pathway, thus suppressing tumor cell proliferation and inducing apoptosis [3]. - Phase II clinical trials showed a median follow-up of 15.1 months, with an objective response rate (ORR) of 60.5% and a median time to response (TTR) of 4.7 months, indicating rapid efficacy and good tolerability [3]. Group 4: Broader Implications for Rare Tumors - The drug also addresses a significant unmet need in the treatment of adult LCH and other histiocytic tumors, with an ORR of 82.8% in a Phase II trial for 29 patients, and a median time to response of only 2.9 months [4]. - Future clinical trials are planned for additional conditions, including low-grade gliomas and pediatric LCH, indicating the potential for broader applications of Luwo Meitini [4].
医药工业百强企业出口回升显著,多部委释放“出海”利好信号
Di Yi Cai Jing· 2025-07-07 12:06
Core Insights - In 2024, despite ongoing pressure on performance, the top 100 pharmaceutical companies in China are increasing their innovation efforts, with an average R&D expenditure of 830 million yuan, a year-on-year increase of 6.3% [1][6] - The overall revenue of the top 100 companies has declined for three consecutive years, totaling 1,004.97 billion yuan in 2024, indicating challenges from market demand changes and policy adjustments [3][4] - The export value of the top 100 companies has rebounded significantly, with a year-on-year growth of 9.4%, contrasting with the overall industry pressure [4][5] R&D Investment - The average R&D expenditure of the top 100 companies reached a historical high of 830 million yuan in 2024, which is 3.2 times that of ten years ago [6] - 13 companies had an R&D intensity exceeding 15%, with 7 companies surpassing 20% [6] - The R&D investment intensity increased to 8.2%, reflecting a commitment to innovation even amid performance declines [6] Market Dynamics - The pharmaceutical industry is undergoing a structural adjustment from scale growth to quality and efficiency, influenced by localizing foreign companies, innovation transformations of domestic firms, and rapid development in biopharmaceuticals [1][3][10] - The concentration of the industry remains stable, with the top 100 companies accounting for 33.8% of the total revenue, a slight decrease of 1.1 percentage points from the previous year [3][4] Export Performance - The export delivery value of the top 100 companies showed a significant recovery, driven by global market demand, ongoing internationalization strategies, and an upgrade in product structure towards higher value [4][5] - In 2024, Chinese pharmaceutical companies completed over 90 overseas authorizations, with a total transaction value exceeding 50 billion USD [4][5] Innovation and Product Development - A total of 48 innovative drugs were approved in 2024, with 12 coming from the top 100 companies, including several breakthrough therapies [7][8] - The competitive landscape is shifting, with 42 companies achieving growth in both revenue and profit, while 31 companies experienced declines [8][9] Emerging Players - New entrants in the top 10 include Novo Nordisk (China), which entered the list for the first time, and Heng Rui Medicine, which returned with a strong proportion of innovative drug revenue [9][10] - These companies exemplify successful models of localization, innovation transformation, and rapid biopharmaceutical development [10]