证券代码：002653 证券简称：海思科 公告编号：2025-096 海思科医药集团股份有限公司 关于创新药 HSK47977 片获得 FDA 药物临床试验批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司（以下简称"公司"）于近日收到 HSK47977 片美国食品药品监督管理局（FDA）下发的 Study May Proceed Letter（药物临床试验批准通知书）。根据 FDA 相关规定， 经审查，HSK47977 片临床试验申请符合药品注册的有关要求，同意 本品开展临床试验。 一、 研发项目简介 HSK47977 片是海思科自主研发的一种口服 BCL6（人 B 细胞淋巴 瘤因子 6）PROTAC 小分子制剂，可以靶向结合和降解 BCL6 蛋白，进 而抑制肿瘤细胞的发生和发展，拟用于淋巴瘤的治疗。在多项临床前 研究中，HSK47977 均展现出强效的抗肿瘤活性，同时也表现出较强 的靶点选择性和理想的安全窗。本项目国内尚无同靶点药物进入临床 阶段，是潜在的 First-In-Class 产品。 同时，HSK47977 片 ...

海思科9月1日公告，近日收到HSK47977片美国食品药品监督管理局(FDA)下发的Study May Proceed Letter(药物临床试验批准通知书)。根据FDA相关规定，经审查，HSK47977片临床试验申请符合药品注 册的有关要求，同意本品开展临床试验。HSK47977片是海思科自主研发的一种口服BCL6(人B细胞淋巴 瘤因子6)PROTAC小分子制剂，可以靶向结合和降解BCL6蛋白，进而抑制肿瘤细胞的发生和发展，拟 用于淋巴瘤的治疗。 ...

每经AI快讯，9月1日，海思科（002653）(002653.SZ)公告称，公司近日收到FDA下发的Study May Proceed Letter，同意HSK47977片开展临床试验。HSK47977片是海思科自主研发的口服BCL6PROTAC 小分子制剂，拟用于淋巴瘤治疗。此外，该药已于8月获得国家药品监督管理局的临床试验批准通知 书，并完成首例受试者入组。 ...

证券之星消息，根据企查查数据显示海思科（002653）公布了一项国际专利申请，专利名为"一种喹唑 啉酮衍生物的晶型及其制备方法和应用"，专利申请号为PCT/CN2025/077968，国际公布日为2025年8月 28日。 专利详情如下： 图片来源：世界知识产权组织（WIPO） 今年以来海思科已公布的国际专利申请24个。结合公司2025年中报财务数据，今年上半年公司在研发方 面投入了3.42亿元，同比增59.22%。 数据来源：企查查 以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 ...

东吴证券研报指出，海思科上半年实现归母净利润1.29亿元，同比下降21.79%。整体毛利率72.96%，相 比2024年全年的71.46%有所提升。费用端方面，25年H1销售费用7.27亿元，费用率36.35%，保持稳定 水平。研发费用3.42亿元，同比增长59.22%，研发投入支撑公司创新药管线开发。麻醉产品引领销售放 量，环泊酚海外上市顺利推进中：营收分板块看，麻醉25年H1收入7.96亿元，同比增长54%。肠外营养 收入2.06亿元，同比下降19.39%。肿瘤止吐收入1.63亿元，同比增长19.9%。核心麻醉产品环泊酚快速 放量，带动公司向创新药销售转型。环泊酚未来有望海外上市，多个管线已经纳入医保，将成为业绩新 增长点，后续创新管线催化剂充足，维持"买入"评级。 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The sales of anesthetic products meet expectations, and the innovative pipeline is entering a commercialization phase [8] - The company reported a total revenue of 2.001 billion yuan in the first half of 2025, representing an 18.63% year-on-year growth, while the net profit attributable to shareholders decreased by 21.79% to 129 million yuan [8] - The core anesthetic product, Remifentanil, has rapidly gained market share, with a 22.3% share in the intravenous anesthetic market as of Q1 2025, surpassing competitors [8] - The company has multiple innovative pipelines progressing, with several clinical registrations underway, including HSK21542 and HSK16149, which are expected to contribute to future revenue growth [8] Financial Summary - Total revenue forecast for 2025 is 4.583 billion yuan, with a year-on-year growth of 23.15% [1][9] - The net profit attributable to shareholders is projected to be 522 million yuan in 2025, with a growth rate of 31.93% [1][9] - The earnings per share (EPS) is expected to be 0.47 yuan in 2025, with a price-to-earnings (P/E) ratio of 127.50 [1][9] - The company’s gross margin is expected to improve to 73.50% by 2026 [9]

Group 1 - A-share market sees a decline in several innovative drug concept stocks, with Yuekang Pharmaceutical dropping over 10% [1] - Guangshengtang falls by 8%, while Lifang Pharmaceutical and Haishike decrease by over 7% [1] - Saili Medical declines by over 6%, and Huiyu Pharmaceutical drops by over 5% [1] - Jingxin Pharmaceutical experiences a decline of over 4%, with Shutaishen, Haiteshengwu, and Xinlitai all falling by over 3% [1]

Investment Rating - The investment rating for the company is "Outperform the Market" [5][16]. Core Viewpoints - The company has seen a significant revenue increase of 54% in its anesthesia products, with total revenue reaching 2.001 billion yuan in the first half of 2025, representing an 18.6% year-on-year growth [1][8]. - The company is entering a harvest period for its innovative drugs, with multiple products approved for commercialization, including pain management and diabetes treatment medications [2][16]. - The company maintains a strong pipeline with ongoing clinical trials for various indications, indicating robust future growth potential [3][16]. Financial Performance Summary - In the first half of 2025, the company reported a gross margin of 71.5%, a net profit margin of 10.6%, and an overall expense ratio of 63.5% [2][12]. - Revenue breakdown by product area shows anesthesia products generating 796 million yuan, parenteral nutrition at 206 million yuan, antiemetic drugs at 163 million yuan, and other indications at 340 million yuan [1][8]. - The company forecasts net profits of 546 million yuan, 692 million yuan, and 866 million yuan for 2025, 2026, and 2027 respectively, with corresponding P/E ratios of 122, 96, and 77 [4][16].

证券研究报告|公司点评报告 [Table_Date] 2025 年 08 月 25 日 [Table_Title] 聚焦创新药研发，长期增长动能强劲 [Table_Title2] 海思科(002653) [Table_Summary] 事件概述 2025H1 公司实现营收 20.0 亿元（yoy+18.6%），归母净利润 1.3 亿 元 （ yoy -21.8% ）， 扣 非 归 母 净 利 润 1.4 亿 元 （ yoy +90.8%）。单 Q2 营收 11.1 亿元（yoy+18.7%），归母净利润 0.8 亿元（yoy+13.0%），扣非归母净利润 0.9 亿元（yoy+104.8%）； 业绩符合我们预期。 盈利能力方面，2025H1 公司毛利率 73.0%（+1.0pcts），其中自 产产品毛利率高达 80.36%，合作产品毛利率为 50.13%；归母净 利率 6.4%（-3.3pcts），扣非归母净利率 7.2%（+2.7pcts）；单 Q2 毛 利 率 75.1% （ -3.01pcts ）， 归 母 净 利 率 7.4% （ - 0.4pcts），扣非归母净利率 8.5%（+3.6pcts）。 ...

Summary of Haishi Science Conference Call Company Overview - **Company**: Haishi Science (海思科) - **Industry**: Pharmaceutical and Biotechnology Key Points Financial Performance - Haishi Science expects a **20% revenue growth** for the full year of 2025, with projected revenue reaching **20 billion RMB** in the first half of 2025, marking an **18% year-over-year increase** [2][3] - The company achieved a record **11 billion RMB** in revenue for Q2 2025, with a **90% increase** in net profit [3] Product Revenue Projections - **Ringbofen** (环泊酚) is expected to generate **1.6 billion RMB** in revenue for 2025, while products **16,149** and **7,653** are projected to reach **300 million RMB** in total revenue [2][4] - By the end of 2029, Haishi Science aims for total revenue to grow to **10 billion RMB**, with innovative drug sales exceeding **7 billion RMB** [2][6] Research and Development - R&D expenses increased by **60%** year-over-year to **500 million RMB** in the first half of 2025, with a focus on multiple projects across various therapeutic areas [2][9] - The company is advancing several clinical trials, including **39,297** for PNH and **31,858** for non-cystic fibrosis bronchiectasis, with NDA submissions planned for late 2025 and early 2026, respectively [7][17] Market Strategy - Haishi Science plans to launch **1 to 3 new products annually** and is pursuing a dual-filing strategy in the U.S. and China [5][23] - The company is focusing on the respiratory field, targeting diseases such as COPD, IPF, and asthma, with specific attention to the **DP1**, **PDE34**, and **PDE14B** targets [5][18] Competitive Landscape - **PD34** is positioned for asthma treatment, with no current plans to expand its indications [20] - The company is exploring potential synergies between its respiratory products to enhance treatment efficacy [19] Future Outlook - Haishi Science is optimistic about the commercialization of its new products, with **16,149** and **7,653** expected to maintain sales around **60 million RMB** each for 2025 [11] - The company does not plan to enter the nuclear medicine field but remains focused on other innovative therapies [11][26] Financial Management - The company has improved cash flow significantly in Q2 2025 due to enhanced payment cycles and financial policy optimizations [21] International Development - Haishi Science is actively pursuing international clinical trials, particularly for product **47,388**, with plans for IND submissions in the U.S. [22][23] Conclusion - Haishi Science is on a growth trajectory with ambitious revenue targets, a strong pipeline of innovative drugs, and a strategic focus on international expansion and R&D investment to drive future success [25][26]