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。 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）。 根据 IQVIA CHPA 最新数据 1，2024 年，注射用奈达铂于中国境内（不包括港澳 台地区）的销售额约为人民币 3.53 亿元。 三、风险提示 该药品在进行商业化生产前，尚需（其中主要包括）获得药品注册批准等。本 次获药品注册申请受理不会对本集团现阶段业绩产生重大影响。 1 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 ...

人民财讯8月12日电，复星医药（600196）8月12日晚间公告，控股子公司吉斯美(武汉)制药有限公司就 注射用奈达铂的药品注册申请获国家药监局受理。 该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。 ...

该药品为集团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。 复星医药(600196.SH)发布公告，近日，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的药 品注册申请获国家药品监督管理局受理。 ...

格隆汇8月12日丨复星医药(600196.SH)公布，控股子公司吉斯美（武汉）制药有限公司就注射用奈达铂 的药品注册申请获国家药品监督管理局受理。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。 ...

Core Viewpoint - The precision medicine sector experienced a slight increase of 0.09% on August 12, with Fosun Pharma leading the gains, while the overall market indices also showed positive movement [1]. Market Performance - The Shanghai Composite Index closed at 3665.92, up 0.5% - The Shenzhen Component Index closed at 11351.63, up 0.53% [1]. Individual Stock Performance - Fosun Pharma (600196) closed at 27.70, up 3.36% with a trading volume of 814,800 shares and a transaction value of 2.266 billion - Guomai Technology (002093) closed at 12.65, up 2.93% with a trading volume of 678,600 shares and a transaction value of 853 million - Ruian Gene (688217) closed at 31.57, up 2.20% with a trading volume of 23,000 shares and a transaction value of 71.8823 million - Other notable stocks include Yangpu Medical (300030) up 1.90% and ST Xiangxue (300147) up 1.17% [1]. Fund Flow Analysis - The precision medicine sector saw a net outflow of 694 million from institutional investors, while retail investors contributed a net inflow of 582 million [2]. - The overall fund flow indicates a mixed sentiment, with institutional investors withdrawing capital while retail investors showed interest [2]. Detailed Fund Flow for Selected Stocks - Guomai Technology (002093) had a net inflow of 39.2158 million from institutional investors, while retail investors had a net outflow of 51.1835 million - Lianying Medical (688271) saw a net inflow of 32.2221 million from institutional investors, but a net outflow of 23.1791 million from retail investors - Yangpu Medical (300030) had a net inflow of 19.3205 million from institutional investors, with retail investors also showing a net outflow [3].

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 23.2, indicating a potential upside of 19.5% from the current price of HKD 19.34 [4][5]. Core Insights - The company has entered into a licensing agreement with Expedition for the development, production, and commercialization of the investigational product XH-S004 outside of China and Hong Kong, with potential revenues of up to USD 650 million [5][6]. - The DPP-1 small molecule drug XH-S004 has significant market potential, targeting conditions such as non-cystic fibrosis bronchiectasis and chronic obstructive pulmonary disease, with a growing global interest in DPP-1 inhibitors [6][10]. - The company has adjusted its profit forecasts upwards due to the recent business development transaction, projecting net profits of RMB 34.3 billion, RMB 39.2 billion, and RMB 46.1 billion for 2025-2027, representing year-over-year growth rates of 24%, 14%, and 17% respectively [6][8]. Financial Summary - The company’s projected net profit for 2025 is RMB 34.35 billion, with an EPS of RMB 1.29, and a corresponding H-share PE ratio of 14X [8][11]. - Revenue forecasts for the company are set at RMB 44.87 billion for 2025, with a steady increase expected in subsequent years [11]. - The company’s dividend per share (DPS) is projected to grow from RMB 0.39 in 2025 to RMB 0.52 by 2027, reflecting a dividend yield increase from 1.44% to 1.93% [8][11].

Core Viewpoint - The recent announcement by Fosun Pharma regarding the approval of RT002 (DaxibotulinumtoxinA) for treating adult cervical dystonia indicates a potential expansion of botulinum toxin applications beyond aesthetic uses into therapeutic areas [1][4]. Industry Overview - The primary application of botulinum toxin in the domestic market remains in the medical aesthetics sector, where it is highly favored for procedures such as wrinkle reduction, facial slimming, and shaping [2][3]. - In 2020, botulinum toxin accounted for approximately 58% of the global injectable product market, surpassing hyaluronic acid, which held a 40% share [2]. Competitive Landscape - Numerous medical aesthetic companies are actively developing botulinum toxin products through acquisitions, independent research, and exclusive licensing agreements [3]. - The market currently features four major products, with competition expected to intensify as more players enter the market [3]. Therapeutic Potential - The therapeutic applications of botulinum toxin are significant, with potential uses in treating conditions such as strabismus, muscle tension disorders, migraines, obesity, and excessive sweating, spanning various medical specialties [5][6]. - Compared to developed countries, the range of approved indications for botulinum toxin in China is relatively limited, suggesting substantial growth potential in the market as more indications undergo clinical trials [6]. Development Challenges - The development cycle for botulinum toxin is lengthy and costly, with high barriers to entry due to regulatory scrutiny and the complexity of industrial production processes [7]. - The typical timeline for a drug to move from development to approval can take 8-10 years, highlighting the significant investment required in both time and resources [7].

Core Insights - The article highlights the recent achievements of Chinese pharmaceutical companies, particularly Heng Rui Medicine and Fosun Pharma, in obtaining Fast Track Designation (FTD) from the FDA for their innovative drugs, indicating a significant step in the internationalization of Chinese pharmaceuticals [1][2]. Group 1: Fast Track Designation - Heng Rui Medicine's SHR-A2009 is the first innovative drug from the company to receive FDA's Fast Track Designation, which is expected to expedite its clinical trials and market registration [2]. - Fosun Pharma's subsidiary, Hanhui, also received FTD for HLX42, a drug targeting advanced non-small cell lung cancer, with a cumulative R&D investment of approximately 6.285 million yuan [2]. - The FTD status allows for increased communication with the FDA during the drug development process, facilitating quicker identification and resolution of issues [3]. Group 2: ADC Market Growth - Both SHR-A2009 and HLX42 are part of the Antibody-Drug Conjugate (ADC) sector, which has seen a surge in interest and investment from Chinese companies [4]. - As of December 2023, over 20 ADC transactions have occurred, with a total value exceeding 35 billion USD, indicating a robust market for these innovative therapies [4]. - The global ADC market is projected to grow from 11.4 billion USD in 2023 to 64.7 billion USD by 2030, with a compound annual growth rate (CAGR) of 28.1% [4]. Group 3: International Expansion of Chinese Pharma - 2023 is marked as a breakthrough year for Chinese innovative drugs entering international markets, with several companies achieving FDA approvals [6]. - Chinese pharmaceutical companies are encouraged to develop competitive products to capture overseas market share while also focusing on domestic and international sales strategies [6]. - The recognition of Chinese innovation in the global pharmaceutical ecosystem is increasing, as evidenced by successful licensing agreements for various innovative therapies [6].

Core Viewpoint - Fosun Pharma (02196.HK) experienced a significant stock price increase following the announcement of a licensing agreement with Expedition for the development and commercialization of the investigational product XH-S004 outside of China and Hong Kong [1] Group 1: Licensing Agreement Details - Fosun Pharma's subsidiary granted Expedition rights to develop, produce, and commercialize XH-S004 in a global scope excluding mainland China and Hong Kong [1] - Expedition will pay up to $120 million in non-refundable upfront payments and milestone payments related to development and regulatory achievements [1] - Additionally, based on annual net sales performance of the licensed product, Expedition may pay up to $525 million in sales milestone payments to Fosun Pharma [1] Group 2: Product Information - XH-S004 is a small molecule oral DPP-1 inhibitor with potential indications including non-cystic fibrosis bronchiectasis and chronic obstructive pulmonary disease (COPD) [1] - The product is currently in Phase II clinical trials for treating non-cystic fibrosis bronchiectasis and in Phase Ib clinical trials for COPD within mainland China [1]

Core Viewpoint - The news highlights the significant developments in the innovative pharmaceutical sector, particularly focusing on Fosun Pharma's recent licensing agreement and the broader trends in AI-driven drug discovery and CAR-T therapies. Group 1: Fosun Pharma's Licensing Agreement - Fosun Pharma signed a licensing agreement with Expedition for the small molecule inhibitor XH-S004, with a potential total value of $645 million (over 4.6 billion RMB) [2][3] - The agreement allows Expedition to develop, produce, and commercialize XH-S004 outside of China, while Fosun retains rights for the Chinese market [2][3] - XH-S004 is currently in Phase II clinical trials for non-cystic fibrosis bronchiectasis and Phase Ib for chronic obstructive pulmonary disease in China, with a cumulative R&D investment of approximately 72 million RMB as of August 11 [2][4] Group 2: Competitive Landscape - The leading competitor in the small molecule inhibitor space is Insmed's Brensocatib, which is under FDA review and may become the first approved treatment for bronchiectasis [4] - Other domestic companies, such as Haikang and Hengrui, are also advancing in this area, with Haikang securing a significant licensing deal worth up to $4.62 million [4] Group 3: AI Drug Discovery - Fosun Pharma is actively involved in AI drug discovery, having partnered with AI pharmaceutical company Insilico Medicine since 2022 to develop AI-targeted drugs [5] - The company has also engaged in strategic collaborations with DeepMind Technology to explore antibody drug development using AI and physical modeling [5] Group 4: CAR-T Therapy Developments - Fosun Pharma is recognized for its CAR-T therapy pipeline, with the CARVYKTI therapy achieving sales of $439 million in Q2 2025, indicating strong market potential [6] - The pricing of CAR-T therapies remains a challenge, with costs exceeding 999,000 to 1,290,000 RMB, which limits access to insurance coverage [6] - The evolving payment landscape for CAR-T therapies is expected to improve as generic technologies mature and more products enter the market, potentially lowering costs [6] Group 5: Market Outlook - The innovative drug sector is anticipated to remain active, with significant upcoming international pharmaceutical conferences and discussions on insurance drug lists expected to drive interest [7] - The domestic innovative drug market is likely to benefit from increased clinical data releases and a rebound in funding for new drug development [7] - Investors are encouraged to consider the innovative drug ETF (159622) for exposure to leading companies in the sector, with a diversified portfolio comprising 40% Hong Kong stocks and 60% A-shares [7]