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 司上海复宏汉霖生物技术股份有限公司及其控股子公司（以下合称"复宏汉霖"） 自主研发的 60 mg/mL、120 mg/1.7mL 两项规格的地舒单抗注射液（项目代号：HLX14） 的生物制品许可申请（BLA）获美国 FDA（即美国食品药品监督管理局）批准，本次 获批情况如下： 证券代码：600196 股票简称：复星医药 编号：临 2025-143 上海复星医药（集团）股份有限公司 关于控股子公司获美国 FDA 药品注册批准的公告 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。 一、概况 | 美国商品名 | 获批适应症 | | --- | --- | | | （1）骨折高风险的绝经后妇女的骨质疏松症治疗； （2）骨折高风险的男性骨质疏松患者的增加骨量治疗； | | | （3）糖皮质激素引起的骨折高风险的男性与女性骨质疏松症的 | | 产品一：BILDYOS®1 | 治疗； | | （60 mg/mL） | （4）接受雄激素剥夺治疗的骨折高风险的非转移性前列腺癌 ...

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 控股子公司獲美國FDA藥品註冊批准的公告》，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9 月1 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 ...

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, received FDA approval for its self-developed denosumab injection (HLX14) in two specifications, which includes five indications for osteoporosis treatment [1] Group 1: Product Approval - The FDA approved the biologics license application (BLA) for denosumab injection in two concentrations: 60mg/mL and 120mg/1.7mL [1] - The approved indications include treatment for osteoporosis in postmenopausal women, osteoporosis in male patients, glucocorticoid-induced osteoporosis, non-metastatic prostate cancer in male patients undergoing androgen deprivation therapy, and breast cancer in women receiving aromatase inhibitor therapy [1] Group 2: Market Potential - The global sales revenue for denosumab injection is approximately $7.462 billion [1]

FF301 致：香港交易及結算所有限公司 公司名稱: 上海復星醫藥(集團)股份有限公司 ( 於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02196 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 551,940,500 | RMB | | 1 RMB | | 551,940,500 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 551,940,500 | RMB | | 1 RMB | | 551,940,500 | ...

Summary of Key Points Core Viewpoint - As of September 1, a total of 110 stocks reached their 52-week highs, with notable performances from Hejia Holdings (33.33%), International Commercial Settlement (30.00%), and Xinjiang Xinmin Mining (24.16%) [1]. 52-Week Highs - Hejia Holdings (00704) closed at 0.217 with a peak of 0.280, achieving a high rate of 33.33% [1]. - International Commercial Settlement (00147) reached a closing price of 0.430 and a high of 0.455, marking a 30.00% increase [1]. - Xinjiang Xinmin Mining (03833) had a closing price of 1.770 and a peak of 1.850, resulting in a 24.16% high rate [1]. - Other notable stocks include: - Shuoao International (02336) at 22.38% [1] - Sanleaf Bio-B (02197) at 16.00% [1] - Wanka Yilian (01762) at 13.08% [1] 52-Week Lows - INTL Genius (00033) recorded a low rate of -14.89% with a closing price of 0.410 [3]. - Junan Holdings (01559) saw a decline of -14.10%, closing at 0.069 [3]. - Other significant declines include: - Kuangshi Fragrance (01925) at -8.41% [3] - Baida Group Holdings (08179) at -8.33% [3] - Shimao Group (00813) at -7.58% [3]

截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 公司名稱: 上海復星醫藥(集團)股份有限公司 ( 於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02196 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 551,940,500 | RMB | | 1 RMB | | 551,940,500 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 551,940,500 | RMB | | 1 RMB | | 551,940,500 | ...

Investment Rating - The report provides a positive outlook on the MASH non-invasive diagnosis technology, suggesting it could accelerate new drug development in the pharmaceutical and biotechnology sector [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 0.65% from August 25 to August 29, underperforming compared to the Wind All A index (1.9%) and the CSI 300 index (2.71%). Only the medical research outsourcing (4.9%) and other biological products (0.14%) sectors saw gains, while in vitro diagnostics (-4.12%), raw materials (-3.34%), and vaccines (-0.59%) faced significant declines [2][7]. - The FDA has accepted the proposal for using VCTE-LSM as a reasonable alternative endpoint for clinical trials in adults with MASH and moderate to advanced fibrosis. This non-invasive method is expected to enhance patient compliance and could lead to a surge in drug development in the MASH area within the next two to three years [2][13]. - The report emphasizes the potential for domestic companies in China to leverage their cost advantages and forward-looking strategies in the field of non-invasive companion diagnostics, particularly in the MASH drug development competition [2]. Market Weekly Review - The pharmaceutical and biotechnology sector's performance was notably weaker than the broader market indices, with specific sub-sectors like medical research outsourcing and other biological products showing resilience [7][8]. - Individual stocks such as Tianchen Medical (30.1%), Ailis (25.6%), and Maiwei Biotech-U (22.4%) performed well, while stocks like Lifang Pharmaceutical (-13.9%), Yuekang Pharmaceutical (-11.9%), and Kanghua Biotech (-11.1%) faced significant losses [10][12]. Industry News and Key Company Announcements - On August 28, Kangfang Biotech announced that its drug AK112 received approval for treating advanced non-squamous non-small cell lung cancer, with promising clinical trial results expected to be presented at an international conference [12]. - The report highlights various companies' financial performances, with notable revenue changes and profit margins, indicating a mixed outlook across the sector [16][17].

Core Viewpoint - The performance of innovative pharmaceutical companies in China for the first half of 2025 has been impressive, with significant revenue and profit growth driven by innovative drug sales, indicating a potential recovery in the pharmaceutical industry [1][6][15]. Group 1: Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, with a net profit of 4.45 billion yuan, up 29.67%. Innovative drug sales accounted for 60.66% of total revenue [3][9]. - BeiGene reported total revenue of 17.52 billion yuan, a 46.0% increase year-on-year, with a net profit of 450 million yuan, marking a turnaround from losses [3][6]. - China Biopharmaceutical's revenue reached 17.57 billion yuan, a 10.7% increase, with innovative product revenue of 7.8 billion yuan, up 27.2%, representing 44.4% of total revenue [3][6]. - XinDa Biopharmaceutical achieved revenue of 5.95 billion yuan, a 50.6% increase, and a net profit of 1.21 billion yuan, turning a loss from the previous year [7][8]. - Xiansheng Pharmaceutical reported a revenue increase of 15.1% to 3.58 billion yuan, with innovative drug revenue surpassing 75% of total revenue [8]. Group 2: Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies suggests a shift towards innovation-driven strategies, indicating a growing market for innovative drugs in China [6][8][15]. - The second-tier market is experiencing a prosperous phase, leading to speculation about a potential "spring" for the pharmaceutical industry, although the primary market remains challenging [4][15]. - The demand for high-quality products that can compete globally is increasing, with a focus on "best-in-class" products [4][15]. Group 3: Business Development (BD) Contributions - Business development (BD) activities are becoming crucial for the growth of innovative pharmaceutical companies, with significant deals contributing to revenue [9][10]. - Heng Rui Pharmaceutical's BD activities included a $1.97 billion contract with Merck and a partnership with GSK, highlighting the increasing global engagement of Chinese innovative drug companies [10][11]. - The first half of 2025 saw over 50 BD transactions in China's innovative drug sector, with a total disclosed cooperation amount exceeding $48.44 billion, marking a significant increase compared to the previous year [10][11]. Group 4: Challenges and Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [13][14]. - Some companies, like BeiDa TianHeng, reported significant revenue declines due to high R&D investments and previous income recognition from collaborations [13][14]. - Overall, the industry is transitioning from an "investment phase" to a "harvest phase," indicating a recovery in profitability and a moderate expansion phase [14][15].

Core Viewpoint - The performance of innovative pharmaceutical companies in China for the first half of 2025 is impressive, with significant revenue and profit growth driven by innovative drug sales, indicating a potential recovery in the pharmaceutical industry [1][3][10]. Summary by Sections Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.761 billion yuan, a year-on-year increase of 15.88%, and a net profit of 4.450 billion yuan, up 29.67%. Innovative drug sales accounted for 60.66% of total revenue [3][12]. - Bai Jie Shen Zhou reported total revenue of 17.518 billion yuan, a 46.0% increase, with a net profit of 450 million yuan, marking a turnaround from losses. The sales of its key products, including the BTK inhibitor and PD-1 inhibitor, significantly contributed to this growth [3][7]. - Xin Da Biotech achieved revenue of 5.953 billion yuan, a 50.6% increase, and a net profit of 1.213 billion yuan, compared to a loss in the previous year, driven by strong sales of its PD-1 inhibitor and new weight-loss drug [8]. - Xian Sheng Pharmaceutical reported a revenue increase of 15.1% to 3.585 billion yuan, with innovative drug revenue reaching 2.776 billion yuan, accounting for 77.4% of total revenue [9]. Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies suggests a shift towards innovation-driven strategies, with increasing market demand for innovative products supported by healthcare policies [10][20]. - Business Development (BD) activities are becoming crucial for growth, with significant deals indicating a robust international presence for Chinese innovative drug companies [12][13]. Challenges and Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [18]. - Some companies, like Bai Li Tian Heng and Bei Da Pharmaceutical, reported declines in net profit due to high R&D costs and overdue payments to partners, highlighting the risks associated with innovation investments [18][19]. - Overall, the industry is transitioning from a low point to a recovery phase, with expectations for sustained growth in the innovative drug sector driven by efficiency and cost advantages [20].

Core Viewpoint - The performance of innovative pharmaceutical companies in China has shown significant growth in the first half of 2025, with many companies reporting impressive revenue and profit increases driven by innovative drug sales [1][4][7]. Group 1: Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, and a net profit of 4.45 billion yuan, up 29.67%, with innovative drug sales accounting for 60.66% of total revenue [1][8]. - BeiGene reported total revenue of 17.52 billion yuan, a 46.0% increase year-on-year, with a net profit of 450 million yuan, marking a turnaround from losses [1][4]. - Innovent Biologics achieved revenue of 5.95 billion yuan, a 50.6% increase, and a net profit of 1.21 billion yuan, compared to a loss of 160 million yuan in the previous year [5]. - Xiansheng Pharmaceutical reported a revenue increase of 15.1% to 3.58 billion yuan, with innovative drug revenue reaching 2.78 billion yuan, accounting for 77.4% of total revenue [6]. Group 2: Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies indicates a successful shift towards innovation-driven strategies, with increasing market demand for innovative products [7][12]. - The Chinese innovative drug market is expanding, supported by improved public health awareness and favorable healthcare policies [7][12]. - Business development (BD) activities have become a crucial growth engine for innovative pharmaceutical companies, with significant increases in BD transactions in the first half of 2025 [9][10]. Group 3: Challenges and Future Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [12][13]. - The overall industry is transitioning from a low point, with profitability beginning to recover, indicating a shift from an "investment phase" to a "harvest phase" [12][14]. - Analysts predict that the innovative drug sector will continue to thrive, driven by high efficiency and low-cost development advantages, particularly in popular technology areas [12][14].