Core Viewpoint - Fosun Pharma has successfully completed the first batch shipment of its self-developed drug, Luwo Meitini Tablets (Fumainin®), marking its imminent clinical use and addressing patient medication needs [1][5]. Group 1: Product Launch and Approval - Fumainin® is the first and only targeted drug in China approved for dual indications: adult Langerhans cell histiocytosis (LCH) and tissue tumors, as well as type I neurofibromatosis for children aged 2 and above [1][6]. - The drug received approval from the National Medical Products Administration through a priority review and approval process by the end of May 2025 [5]. Group 2: Logistics and Distribution - The first batch of Fumainin® was successfully shipped from the production base of the entrusted manufacturer, Kelaiying Pharmaceutical Group, located in Tianjin [3]. - The logistics team completed a series of complex tasks within 10 working days after obtaining the approval, demonstrating efficient execution and a strong commitment to patient needs [5]. Group 3: Industry Impact and Responsibility - The rapid approval of Fumainin® fills a treatment gap in the rare disease oncology field in China, representing a significant breakthrough in domestic original innovation [6]. - The company emphasizes its responsibility to ensure that Fumainin® reaches patients in need as quickly as possible, reflecting a strong sense of social responsibility [6].

当下最火赛道——创新药再迎重磅利好！ 今日盘后，国家药品监督管理局发布《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》。 其中提到，为进一步支持以临床价值为导向的创新药研发，提高临床研发质效，对符合要求的创新药临床试验 申请在30个工作日内完成审评审批。 近期，医药股利好持续发酵。石药集团公告称，与AstraZeneca订立战略研发合作协议，将收取1.1亿美元预付 款，并有权收取最高52.2亿美元的潜在里程碑（研发+销售）付款；上周五，国务院常务会议研究优化药品和 耗材集采有关举措。另外，近期医药依然存在事件驱动，ADA大会（美国糖尿病协会年会）将于6月20日至23 日举行，该会议是代谢类疾病领域的风向标，多项GLP-1RA前沿研究方向及对应重点药品的临床进展将在会 议上报告。 利好来了 今日，国家药品监督管理局发布公告称，为落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药 产业高质量发展的意见》有关要求，支持创新药研发，国家药监局在开展优化创新药临床试验审评审批试点工 作经验基础上，组织起草了《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》，现向社会 公开征求意见。 其 ...

研究报告 Research Report 15 Jun 2025 翰森制药 Hansoh Pharma (3692 HK) 首次覆盖：中国龙头创新药企，国际化能力持续提升 Leading Innovative Pharma in China Enhances International Competitiveness Continuously : Initiation [Table_yemei1] 观点聚焦 Investment Focus [Table_Info] 首次覆盖优于大市 Initiate with OUTPERFORM 评级 优于大市 OUTPERFORM 现价 HK$29.40 目标价 HK$33.90 HTI ESG 4.5-4.5-5.0 E-S-G: 0-5, (Please refer to the Appendix for ESG comments) 市值 HK$174.85bn / US$22.28bn 日交易额 (3 个月均值) US$38.60mn 发行股票数目 5,947mn 自由流通股 (%) 19% 1 年股价最高最低值 HK$29.90-HK$15.82 注：现价 HK ...

Summary of Zai Jian Pharmaceutical Conference Call Company Overview - **Company**: Zai Jian Pharmaceutical - **Year**: 2024 - **Revenue**: 533 million CNY, a year-on-year increase of 37.91% primarily driven by Donafenib [2][6] - **Net Profit**: -138 million CNY, a decrease of over 50% year-on-year, attributed to revenue growth and R&D expenditure planning [2][6] Key Products and Developments - **Donafenib**: - Approved for liver cancer and thyroid cancer, now included in medical insurance [2][6] - Expected sales of over 500 million CNY in 2024, with steady growth anticipated in 2025 [3][15] - **Recombinant Human Thrombin**: - Launched and included in medical insurance as of December 2023 [15] - **Jikaxitinib**: - Recently approved for myelofibrosis, expected to enter medical insurance negotiations by the end of the year [3][15] - **006 (DLL4 Triantibody)**: - Targeting small cell lung cancer, showing superior data compared to Pembrolizumab in ASCO presentations [2][8] - **005 (PD-1/TIGIT Bispecific Antibody)**: - First-line treatment for cervical cancer, with promising ASCO data showing an unconfirmed OR of 82% [2][8] R&D and Innovation - **R&D Platforms**: - Focus on small molecule drugs, complex protein biologics, and antibody new drugs, covering oncology, bleeding disorders, and inflammatory diseases [2][5] - **U.S. R&D Center**: - Achieved significant progress in anti-tumor fields, complementing domestic R&D efforts [5] - **Future Pipeline**: - Multiple late-stage products nearing commercialization, contributing to sustained revenue and profit growth [3][5] Financial Performance - **Revenue Growth**: - Driven by the commercialization of Donafenib and other products, with a focus on optimizing cost structure and improving operational efficiency [2][6] - **R&D Investment**: - High-intensity R&D spending with a stable sales expense ratio, leading to improved overall operational efficiency [5][6] Market Position and Strategy - **Overseas Market Expansion**: - Active in small cell lung cancer, aiming to compete with Amgen in first-line treatments [3][10] - **Potential Collaborations**: - Focus on partnerships with multinational companies for PDL1 and ADC products in small cell lung cancer [11][10] Challenges and Future Directions - **005 Product Challenges**: - Facing hurdles in the TIGIT pathway, with several overseas trials failing to meet primary endpoints [12] - **Future Product Expansion**: - Plans to explore combinations of PD-1/TIGIT with other products to address non-small cell lung cancer resistance [14] Conclusion - **Growth Potential**: - The company is well-positioned for future growth with a robust pipeline and established products, indicating a strong market presence and potential for significant revenue generation [9][17]

来源|贝多财经 6月13日，轩竹生物科技股份有限公司-B（下称"轩竹生物"）再度递交招股书，报考在港交所上市。据 贝多财经了解，轩竹生物曾于2024年11月递表，此次是"失效"后的一次更新。 更早之前，轩竹生物曾于2022年在上海证券交易所递交招股书，报考在科创板上市，原计划募资24.70 亿元。2023年3月，轩竹生物上会但被暂缓审议。2024年5月，该公司及其保荐人中金公司撤回发行上市 申请。 天眼查App信息显示，轩竹生物成立于2018年9月，位于河北省石家庄市，前身为海南轩竹医药科技有 限公司。目前，该公司的注册资本约为4.5亿元，法定代表人为徐艳君，主要股东包括四环医药等。 | | | 10.22 - 01 在用的需求宜蘭工具 | 天泉 置内层 原名歌 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 中小企业发展于基金旗下机构 | 轩竹生糖料技股份有限公司 | 8 | 天眼一下 | 器 应用 = | 合作通道 · 企 | | 基本信息 156 | | IPO申报 56 | 法律诉讼 2 | 经营风险 999+ | 经 ...

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].