公司报告 | 首次覆盖报告 公司核心在研品种注射用 STSP-0601（通用名：波米泰酶α）凝血因子 X 激活剂，目前有两个适应症处于临床研究阶段，分别是伴抑制物血友病患 者按需治疗和不伴抑制物血友病患者按需治疗。根据相关研究数据，国内 预计血友病患者在 10 万人以上，预计接近三分之一的重度患者在接受凝 血因子补充疗法的长期规范治疗后，会产生抑制物。在伴抑制物血友病方 向，STSP-0601 已获得 CDE 突破性疗法认定，已提交附条件上市申请，并 于 2025 年 5 月 26 日获得了 CDE 的优先审评。 舒泰神（300204） 证券研究报告 以突破性疗法为抓手，开拓细专科大市场 舒泰神：深耕治疗性药物领域二十余载，研发及销售管线丰富 舒泰神 2002 年成立于北京，公司聚焦感染性疾病、呼吸与重症、自身免疫 系统疾病及神经系统疾病等，在研产品 STSP-0601 和 BDB-001 被 CDE 纳入 突破性疗法。公司自主研制开发了国家 1 类新药——注射用鼠神经生长因 子"苏肽生"和同时具有清肠和便秘两个适应症的清肠便秘类药物——聚 乙二醇电解质散剂"舒泰清"。2024 年实现营业收入 3.25 亿元 ...

医药生物 2025 年 06 月 15 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -19% -10% 0% 10% 19% 29% 2024-06 2024-10 2025-02 医药生物 沪深300 相关研究报告 《关注 Protac 自免赛道积极进展—行 业周报》-2025.6.8 《重视Pharma估值重塑的机会—行业 周报》-2025.6.2 《经营拐点显现，动保业务有望贡献 较大业绩弹性，推荐国邦医药—行业 周报》-2025.5.25 chaoshuran@kysec.cn 证书编号：S0790123110015 流感病毒为高致病性病原，新作用机制药物研发势在必行 流感为常见的呼吸道传染病，传染速度快、发病率高、传播范围广、且呈现一定 的季节性。虽然流感在世界各地已被纳入传染性疾病管理，但全球每年仍有高达 约 10 亿人罹患流感，其中 300-500 万例为重症病例，29-65 万例死于流感相关呼 吸道疾病。《Economic burden of seasonal influenza in mainland China from 2011 to 2019》（Chen 等）指出，2011 ...

Core Insights - The global patent drug market has been historically dominated by Western pharmaceutical companies, but Chinese companies are increasingly gaining innovation capabilities supported by national policies [1][2] - Hefei Yifan Pharmaceutical's innovative drug Ryzneuta® has entered the U.S. patent drug market, with a significant price difference compared to its domestic price [1][3] - Ryzneuta® is the first third-generation G-CSF approved in China, the U.S., and Europe, and has shown strong sales performance since its inclusion in the national medical insurance directory [1][4] Group 1: Product and Market Performance - Ryzneuta® is priced at $4,600 (approximately 33,000 RMB) in the U.S., while it is priced at 2,388 RMB domestically, indicating a price difference of 14 times [1][3] - The drug has achieved a revenue growth of 327.73% year-on-year in the first quarter of 2025 [1][4] - The U.S. market is expected to contribute significantly to Yifan Pharmaceutical's revenue, with overseas drug revenue reaching 735 million RMB in 2024, a year-on-year increase of 18.82% [5][6] Group 2: Strategic Initiatives and Future Outlook - Yifan Pharmaceutical is adopting a "low profit, high volume domestically + high premium overseas" strategy to balance market penetration and profitability [4][6] - The company is focusing on international market development and has established a dual-driven model of "independent research and development + cooperative introduction" [6][7] - Ryzneuta® is positioned as a core growth engine for the company, with potential to become a billion-level product as overseas market contributions increase [6][7]

编号：2025-026 | 投资者关系活动 | □特定对象调研□分析师会议 | | | | | --- | --- | --- | --- | --- | | 类别 | □媒体采访√业绩说明会 | | | | | | | □新闻发布会□路演活动 | | | | | □现场参观 | | | | | | □其他（请文字说明其他活动内容） | | | | | 参与单位名称及 | 投资者网上提问 | | | | | 人员姓名 | | | | | | 时间 | | | 2025 年 6 月 12 日 (周四) 下午 14:30~16:50 | | | 地点 | | | | 公司通过全景网"投资者关系互动平台"（https://ir.p5w.net） | | | 采用网络远程的方式召开业绩说明会 | | | | | 上市公司接待人 | 1、财务总监易廷浩 | | | | | 员姓名 | 2、董事会秘书高健 | | | | | | 投资者提出的问题及公司回复情况 | | | | | | 公司就投资者在本次说明会中提出的问题进行了回复： | | | | | | 1、公司目前现金充足，是否考虑择机进行股份回购？ | | | | ...

Core Viewpoint - The recent approval of multiple innovative drugs in China and favorable policies have led to a surge in interest in the Hong Kong innovative drug sector, with several ETFs in the pharmaceutical space seeing gains of over 40% this year [1][2]. Company Overview - He Mei Pharmaceutical Co., Ltd. (referred to as "He Mei Pharmaceutical") has submitted an IPO application to the Hong Kong Stock Exchange, with a post-investment valuation of 3.9 billion RMB after completing six rounds of financing [1][2]. - The company, founded in 2002, focuses on developing small molecule drugs for autoimmune diseases and tumors, with a strong position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [1][2]. Financial Performance - As of the latest financial report, He Mei Pharmaceutical has not yet achieved profitability, with projected revenues of approximately 4.05 million RMB and 5.298 million RMB for 2023 and 2024, respectively, primarily from government subsidies [1][2]. - The company is expected to incur losses of approximately 156 million RMB and 123 million RMB for the same periods [1]. Product Pipeline - He Mei Pharmaceutical has developed seven small molecule drug candidates targeting unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for 12 indications as of May 21, 2025 [2][3]. - The two core products include Mufemilast, a potential first-in-class treatment for psoriasis, and Hemay022, a dual-target EGFR/HER2 inhibitor for advanced breast cancer [4][8]. Mufemilast Details - Mufemilast is a novel PDE4B inhibitor with a favorable safety profile, showing potential for treating psoriasis patients with latent tuberculosis [4][5]. - The global psoriasis drug market is projected to reach 29.621 billion USD in 2024, with a compound annual growth rate of 9.19% from 2024 to 2029 [5][6]. Competitive Landscape - Despite Mufemilast's advantages, the psoriasis treatment market is highly competitive, with numerous new drugs entering the market, posing challenges for commercial success [8][11]. - Hemay022 is currently undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer, facing competition from existing EGFR/HER2 inhibitors [8][9]. Financial Pressure - The company anticipates significant financial pressure due to high R&D expenditures, with projected investments of 123 million RMB and 97 million RMB for 2023 and 2024, respectively [10]. - As of December 31, 2024, the company is expected to hold approximately 150 million RMB in cash and cash equivalents, indicating a tight financial situation [10]. Conclusion - Overall, while He Mei Pharmaceutical's core product for psoriasis shows rapid progress, the intense market competition and ongoing high R&D costs may hinder its ability to attract capital market interest [11].

证券代码：300683 证券简称：海特生物 尊敬的投资者，您好！已有相关临床前研究表明，注射用埃 普奈明可能通过影响免疫微环境的方式，对接受 CAR-T 细胞回输 的患者体内的 CAR-T 细胞扩增产生积极影响，且由于注射用埃普 奈明起效迅速、安全性良好等特点，正在越来越多的进入到国内 主流的血液病医院的 CAR-T 治疗过程中，而包括中国医学科学院 血液病医院、西部战区总医院在内的国内一线血液病医院也在积 极与我司合作开展埃普奈明用于CAR-T前桥接化疗及CAR-T后的 维持治疗等方向的临床试验研究。谢谢 4、研发管线最新的收获进展情况是怎样的？ 尊敬的投资者，您好！公司的在研产品及进展已在定期报告 中披露，请关注公司的定期报告。谢谢。 5、请问埃普奈明新产线布局在哪里？已经立项和开建了 吗？ 尊敬的投资者，您好！埃普奈明新产线布局在武汉海特生物 制药股份有限公司园区内，新扩建的产线正在建设过程中。谢谢。 6、杨总，北京沙东的剩下的股权有没有考虑收购，是不是 埃普奈明销售不及预期，可能不考虑剩下的股权收购了。 尊敬的投资者，您好！埃普奈明销售顺利，符合公司预期， 公司会按照股权收购协议的约定履行相应的义务， ...

Core Viewpoint - Dongyangguang Yangtze Pharmaceutical is progressing towards a merger with Dongyangguang Pharmaceutical, with two out of three prerequisite conditions met for the final merger [1] - The company has submitted a listing application to the Hong Kong Stock Exchange, indicating a clear path for its upcoming market entry [1] - Investor confidence is reflected in the significant increase in shareholding by Hong Kong Stock Connect funds, rising from 11.99% to 33.93% since September 2022, with a market value exceeding 3 billion HKD [1] Group 1: Merger and Market Position - Dongyangguang Pharmaceutical's upcoming listing is seen as a high-value investment opportunity in the biopharmaceutical sector, attracting significant interest from investors [4] - The company has established itself as a leading innovative pharmaceutical enterprise in China, focusing on differentiated innovation to meet clinical needs [5][8] Group 2: Research and Development - Dongyangguang Pharmaceutical has a robust R&D platform with over 1,100 professionals, covering the entire drug development lifecycle [5][6] - The company currently has 150 drugs on the market and over 100 in development, including 49 first-class innovative drugs [6] - The company has filed 2,446 invention patents, with 1,401 granted, ranking first among domestic pharmaceutical companies in patent filings from 2014 to 2023 [6] Group 3: Financial Performance - The company has shown significant revenue growth, with projected revenues of 38.14 billion CNY, 63.86 billion CNY, and 40.19 billion CNY from 2022 to 2024, maintaining a gross margin above 76% [10] - In 2023, the company achieved a net profit of 1.014 billion CNY, with a net profit margin of 15.9% [10] - R&D investment is expected to reach 493 million CNY in 2024, a year-on-year increase of 156.62% [10] Group 4: Product Pipeline and Market Strategy - The company is focusing on three key therapeutic areas: infections, chronic diseases, and oncology, with a diverse product portfolio [10][11] - Dongyangguang Pharmaceutical has established a strong sales network covering 32 provincial regions in China and is expanding into international markets [12] - The company has secured significant licensing agreements, including a $938 million deal with Apollo Therapeutics for its FGF21/GLP-1 dual-specific fusion protein [8][9]

联环药业表示，本次罚没金额占公司合并报表范围最近一个会计年度经审计的营业收入和归属净利润的 比例分别为2.83%和72.53%。上述罚没款金额将相应减少公司2025年度归属净利润6103.82万元。 地塞米松磷酸钠是一种肾上腺皮质激素类药物，具有抗炎、抗过敏、抗风湿、免疫抑制作用，因被证明 对新冠肺炎重症患者有疗效，被编入国内《新型冠状病毒肺炎诊疗方案》（第九版、第十版）推荐用 药，用于重症新冠肺炎临床治疗。 地塞米松原料药垄断案终于尘埃落定。6月11日，江苏联环药业股份有限公司（简称"联环药业"）收到 天津市市场监督管理委员会下发的《行政处罚决定书》，责令其停止违法行为，并处罚款合计6103.82 万元。此前，一同实施垄断的津药药业、仙琚制药也已收到《行政处罚决定书》。而此次被罚没的金 额，占据联环药业去年超七成的净利润。 三家药企累计被罚3.26亿元 根据《行政处罚决定书》，天津市市场监督管理委员会认为，联环药业与具有竞争关系的经营者，以垄 断协议形式变更、固定地塞米松磷酸钠原料药价格，排除、限制了地塞米松磷酸钠原料药销售领域的竞 争，违反了《中华人民共和国反垄断法》相关规定，属于达成并实施"固定或者变更 ...

Core Viewpoint - The company Xiaofang Pharmaceutical (603207) is officially entering the field of traditional Chinese medicine compound preparation new drug development by collaborating with Shanghai Dermatology Hospital to develop a new product for hair loss treatment [2][3]. Group 1: Collaboration and Product Development - Xiaofang Pharmaceutical has signed a cooperation agreement with Shanghai Dermatology Hospital to jointly develop a new drug, Compound Cèbǎi Tincture, aimed at treating various types of hair loss [2]. - The collaboration aims to obtain the new drug (Class 1.1) market approval from the National Medical Products Administration, involving preclinical research and clinical trials [2][3]. - The company will pay a total of 20 million yuan for technology transfer and support, with additional sales commissions after the product is launched [2]. Group 2: Market Potential and Strategic Focus - According to the National Health Commission, the number of people suffering from hair loss in China has exceeded 250 million, with a noticeable increase in younger demographics aged 20-40 due to economic and lifestyle pressures [2]. - The Compound Cèbǎi Tincture has been well-received by patients and shows promising development prospects, potentially becoming the first traditional Chinese medicine preparation for hair loss in China [3]. - Xiaofang Pharmaceutical has a strong focus on over-the-counter external medications and aims to expand its product pipeline while optimizing research and development structures to meet family health needs [3].

议案十 关于修订《股东会议事规则》等公司治理制度的议案 ....... 17 益方生物科技（上海）股份有限公司 为了维护公司全体股东的合法权益，确保股东大会的正常秩序和议事效率， 保证大会的顺利进行，根据《中华人民共和国公司法》（以下简称《公司法》）、 《中华人民共和国证券法》（以下简称《证券法》）、《上市公司股东会规则》 以及《益方生物科技（上海）股份有限公司章程》（以下简称《公司章程》）等 相关规定，益方生物科技（上海）股份有限公司（以下简称"公司"）特制定本 次股东大会会议须知： 一、股东大会设会务组，由公司董事会秘书负责会议的程序安排和会务工作； 二、为保证本次大会的严肃性和正常秩序，切实维护股东的合法权益，务请 出席大会的股东或其代理人及其他出席、列席人员准时到达会场签到确认参会资 格。会议开始后，会议登记应当终止，由会议主持人宣布现场出席会议的股东和 代理人人数及所持有的表决权数量； 三、会议按照会议通知上所列顺序审议、表决议案； 证券代码：688382 证券简称：益方生物 益方生物科技（上海）股份有限公司 二〇二五年六月 目 录 八、出席股东大会的股东及股东代理人，应当对提交表决的议案发表如下意 ...