Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a new indication of its drug, Surulitinib Injection, which is now included in the priority review process [1][2] Group 1 - The drug is an innovative anti-PD-1 monoclonal antibody developed by the group [2] - As of December 12, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, and India, with various indications [2] - Current approved indications in China include first-line treatment for squamous non-small cell lung cancer, extensive small cell lung cancer, esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer [2] Group 2 - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] - The indication for combined chemotherapy in gastric cancer has been included in the breakthrough therapy program by the National Medical Products Administration as of November 2025 [2] - Multiple clinical trials involving the drug are ongoing globally, targeting various cancers such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]

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。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 「庫莫西利膠囊」獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團自 主研發的國家1類創新藥庫莫西利膠囊 (商品名：賽坦欣®) 已獲得中國國家藥品監督管理局 (NMPA) 的上市批准，用於與氟維司群聯合治療既往接受內分泌治療後出現疾病進展的激素受體 (HR) 陽性、 人表皮生長因子受體2 (HER2) 陰性的局部晚期或轉移性乳腺癌患者。 參考文獻： 承董事會命 庫莫西利是全球首創的同時靶向CDK2/4/6的三重抑制劑，對CDK2、CDK4、CDK6激酶有不同程度 的抑制效果，且對CDK4激酶有較強的選擇性抑制能力。基於其獨特的作用機制，庫莫西利不僅有助 於延緩臨床中CDK4/6抑制劑的耐藥問題，還可以減輕骨髓抑制風險[1]。 在關鍵I ...

Investment Rating - The report maintains a "Buy" rating for the company, considering its innovative layout and high dividend yield [3][4]. Core Insights - The blood products business is expected to maintain steady growth, with a significant increase in demand for quadrivalent influenza vaccines. By mid-2025, the company will have 34 plasma collection stations, with four stations expected to exceed 100 tons of plasma collection in 2024 [1]. - The company is actively innovating in the blood products sector, upgrading existing processes and developing new products. This includes the completion of on-site verification for a new 10% intravenous immunoglobulin and plans for a subcutaneous immunoglobulin submission [2]. - The company has implemented a cash dividend of 7 yuan per 10 shares for 2025, resulting in a dividend yield of 4.63% based on the closing price on December 11, 2025. The company aims to enhance the stability and predictability of its cash dividends [3]. Summary by Sections Blood Products Business - The blood products segment is projected to grow steadily, supported by an increase in plasma collection and improved utilization rates. The demand for quadrivalent influenza vaccines has surged, leading to faster inventory turnover [1]. Innovation and R&D - The company is increasing its R&D investments in vaccines, innovative drugs, and biosimilars. Key developments include the advancement of a recombinant herpes zoster vaccine and mRNA vaccines for influenza and respiratory syncytial virus [2]. Financial Performance and Forecast - The company has adjusted its net profit forecasts for 2025 and 2026 to 1.252 billion yuan and 1.472 billion yuan, respectively, reflecting a decrease of 20% and 23% from previous estimates. The projected earnings per share (EPS) for 2025 is 0.69 yuan, with corresponding price-to-earnings (P/E) ratios of 22, 19, and 16 for 2025, 2026, and 2027 [3][8].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [1][10]. Core Insights - The company is positioned to benefit from its integrated raw material and formulation strategy, which is expected to drive growth in the coming years [6][9]. - The company is transitioning towards innovation, focusing on self-developed biological drugs in the fields of oncology and autoimmune diseases, with a robust pipeline of projects [9][65]. - The financial forecast indicates a recovery in revenue and profit margins, with significant growth expected from innovative drug approvals [10][26]. Summary by Sections 1. Integrated Raw Material and Formulation Layout - The company has established itself as a leading pharmaceutical manufacturer in China, with a strong focus on both raw materials and formulations [20][23]. - The company has faced pricing pressures in raw materials and formulations but is expected to see a recovery in performance starting in 2024 [24][25]. 2. Dual-Driven Growth from Raw Materials and Formulations - The raw material business remains stable, with a diverse product lineup and a strong global sales network [41][43]. - The formulation segment has seen rapid growth, particularly after benefiting from national procurement policies, with a compound annual growth rate (CAGR) of 24.4% from 2012 to 2024 [59][61]. 3. Focus on Biological New Drugs - The company is actively developing innovative drugs, with over 20 projects in the pipeline, including 12 that have entered clinical trials [65][66]. - Key projects include HB0034, which is nearing commercialization, and HB0017, which has shown promising results in clinical trials for psoriasis and ankylosing spondylitis [69][71]. 4. Financial Forecast and Valuation Analysis - Revenue projections for 2025-2027 are estimated at 86.32 billion, 94.13 billion, and 102.82 billion respectively, with corresponding profit growth rates expected to recover significantly by 2026 [10][26]. - The target market capitalization is set at 344 billion, indicating a potential upside of 30.04% based on industry average price-to-earnings ratios [10][26].

港股创新药连续调整吸引资金关注，12月12日，核心标的港股通创新药ETF（520880）场内价格下探近 5个月低点，场内宽幅溢价，彰显买盘势力！此前4日已有资金连续进场，累计增仓逾1.3亿元。 | 册 多日 1分 * | | | | F9 盘前盘后 盈加 九转 图技 工具 @ 0 | | | | | | | 港股通创新药ETF O | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 0.544 | | | 520880[種設通创新的ETF] 10:20 价 0.537 涨跌 -0.001(-0.19%) | | | 1.12% | | | 0.537 -0.001 -0.19% | | 520880 | | | | 0.543 | | | | | | 0.93% | | | SSE CNY 10:20:39 交易中 查看L2全国 | | | T+0 De / 0 + | | | | | | | | | | 净值市势 | | 华宜恒生港股通创新商 | | 实时中购藏网体息申购 ...

其中，拟用于治疗视神经脊髓炎的创新型CD20注射剂B001，拟用于治疗轻、中度脊髓型颈椎病的中药 1类新药参芪麝蓉丸均已完成III期临床试验全部受试者入组；拟用于治疗肌萎缩侧索硬化症（渐冻症） 的中药1类新药SRD4610，拟用于治疗急性缺血性脑卒中的化药1类新药SHPL-49，近期也都已开展III期 临床试验。 此外，上海医药携手高校及顶尖科研机构共同创立的生命科学创新孵化引擎"上海前沿"，自去年9月份 正式投入运营以来，已吸引了包括国家级生命研究院，拜耳、礼来等著名的跨国药企，以及上国投、上 海生物医药基金等在内的一大批研发创新机构、专业服务机构和科创企业入驻，形成创新要素加速集聚 的良好生态。 上海医药表示，未来将持续在创新研发领域投入，聚焦肿瘤、免疫、心血管、精神神经、消化代谢、抗 感染等临床需求迫切的领域，推动更多具有临床价值的创新药物上市；同时深化"产学研医资"协同创新 生态，加快创新成果转化。 （文章来源：新华财经） 新华财经上海12月12日电（记者杜康）上海医药集团股份有限公司（以下简称"上海医药"）又一款1类 创新药获批。记者获悉，上海上药信谊药厂有限公司申报的1类创新药苹果酸司妥吉仑片已于 ...

新诺威选择在此刻递表，面临的不仅是自身业务的挑战，更是一个日益复杂和挑剔的港股资本市场环 境。其H股发行定价，将直面三重市场现实的拷问。 双重失血？ 新诺威的港股之路，始于一个宏伟蓝图，却陷于现实的泥潭。 起初，作为石药集团旗下的重要资本平台，新诺威被赋予了构建"创新药帝国"的使命，试图从一家功能 性原料(合成咖啡因)生产商，转型为创新药企。其转型路径清晰而大胆：一方面，控股创新药资产平台 巨石生物，布局ADC、mRNA疫苗等前沿领域；另一方面，计划收购控股股东旗下成熟的"现金奶牛"石 药百克，用其稳定利润来反哺创新研发的巨大投入。 然而，这一叙事的关键一环在2025年4月彻底断裂。新诺威终止了对石药百克76亿元的收购。背后的原 因残酷而现实：石药百克的核心产品"津优力"在集采冲击下，价格从约1600元/支骤降至约666元/支，销 量却未实现增长，市场竞争因多款同类长效药物获批而急剧恶化。更重要的是，其被寄予厚望的GLP-1 类减肥药管线，在拥挤的赛道中既无进度优势也无差异化优势，难以填补收入缺口。 失去了外部"供血"，新诺威自身的财务状况迅速恶化，陷入"双重失血"的境地。 一方面，传统的咖啡因业务增长乏力， ...

Core Viewpoint - Shanghai Pharmaceuticals has received approval for its innovative drug, Sitojilun, aimed at treating primary hypertension, marking a significant achievement in its commitment to independent innovation in the pharmaceutical industry [1][2]. Group 1: Product Approval and Market Strategy - The innovative drug Sitojilun (SPH3127), a new generation oral non-peptide small molecule renin inhibitor, has been approved for market launch, addressing unmet clinical needs in hypertension treatment [1]. - Shanghai Pharmaceuticals has established a comprehensive distribution network covering over 80,000 medical institutions across 25 provinces, municipalities, and autonomous regions in China, ensuring effective market access for Sitojilun [1]. Group 2: Research and Development Investment - In 2024, Shanghai Pharmaceuticals plans to invest 2.818 billion yuan in R&D, positioning itself among the industry leaders in investment intensity [2]. - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, with 45 of these being innovative drugs, demonstrating a robust pipeline and commitment to long-term innovation [2]. Group 3: Collaborative Innovation Ecosystem - The company has established the Shanghai Frontier Life Science Innovation Center to foster collaboration with top universities and research institutions, creating an open innovation ecosystem [3]. - Since its launch in September of last year, the center has attracted numerous renowned research institutions and pharmaceutical companies, enhancing the innovation landscape [3]. - Shanghai Pharmaceuticals aims to continue investing in R&D focused on urgent clinical needs in areas such as oncology, immunology, cardiovascular health, and infectious diseases, with the goal of transforming innovative results into marketable products [3].

Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative antiviral drug, Mapasavir Capsules, which is indicated for the treatment of uncomplicated influenza in healthy adolescents and adults aged 12 and above [1][2]. Group 1: Drug Approval and Indications - Mapasavir Capsules (brand name: Yilikang®) is classified as a Class 1 chemical drug and has been granted the registration number H20250070 [1]. - The drug is specifically indicated for the treatment of uncomplicated influenza caused by both influenza A and B viruses, excluding patients at high risk for flu-related complications [1]. Group 2: Clinical Study Results - The approval is based on a Phase III, multi-center, randomized, double-blind study that demonstrated the efficacy and safety of a single oral dose of Mapasavir compared to a placebo in healthy adolescents and adults with uncomplicated influenza [1]. - The study achieved both primary and secondary endpoints, confirming clear clinical benefits [1]. Group 3: Clinical Advantages - Mapasavir Capsules require only a single dose for the entire treatment course, significantly improving patient compliance [2]. - The drug shows good efficacy against both influenza A and B viruses, with a median time to symptom relief reduced by 27 hours compared to the placebo group, which is statistically significant (P < 0.001) [2]. - In adolescents, the median time to symptom relief was shortened by 61 hours compared to the placebo group (P < 0.001) [2]. Group 4: Resistance and Safety Profile - The risk of resistance to Mapasavir is lower, with a total incidence of amino acid substitutions related to decreased sensitivity being 0% for H1N1, 1.2% for H3N2, and 0% for influenza B in the clinical studies [2]. - The safety profile of Mapasavir is favorable, with a low incidence of adverse reactions in the Phase III study, showing comparable or lower rates of overall adverse reactions and those classified by system organ compared to the placebo group [2].

2025年前三季度，公司实现营业收入200万元，同比下滑47.37%；归属于上市公司股东的净利 润-1.55亿元；归属于上市公司股东的扣除非经常性损益的净利润-1.69亿元；经营活动产生的现金流量 净额为-1.72亿元。 | | | 本报告期比 上年同期增 | | 年初至报告期 末比上年同期 | | --- | --- | --- | --- | --- | | 项目 | 本报告期 | | 年初至报告期末 | | | | | 减变动幅度 | | 增减变动幅度 | | | | (%) | | (%) | | 营业收入 | | 不适用 | 2,000,000.00 | -47.37 | | 利润总额 | -50.395.389.71 | 不适用 | -154.767.127.09 | 不适用 | | 归属于上市公司股东的 | -50,395,389.71 | 不适用 | -154.767.127.09 | 不适用 | | 净利润 | | | | | | 归属于上市公司股东的 扣除非经常性损益的净 | -54,587,829.93 | 不适用 | -168.841.741.16 | 不适用 | | 利润 | | | ...