恒瑞医药（600276）(01276)公布2025年中期业绩，收入约人民币157.61亿元，较去年同期增长15.9%;归 属于公司股东的净利润人民币44.5亿元，较去年同期增长29.7%;每股基本盈利人民币0.70元。 公告称，收入、利润增长主要是由于创新药销售及许可收入增加所带动。创新药销售及许可收入人民币 95.61亿元，较去年同期增长26.8%，占收入比重60.7%，其中创新药销售收入人民币75.7亿元。 创新药对外许可作为公司常态化业务，其收入已成为我们营业收入的重要组成部分。报告期内，公司收 到Merck Sharp&Dohme2亿美元以及IDEAYA Biosciences7500万美元的对外许可首付款，并确认为收 入，进一步推动经营业绩指标增长。 此外，尽管纳入集采的仿制药销售收入仍略有下滑，但公司优质仿制产品布比卡因脂质体、美国获批首 仿产品注射用紫杉醇(白蛋白结合型)等报告期内销售收入取得较快增长，带动整体仿製药业务收入实现 小幅提升。 瑞维鲁胺、达尔西利、恒格列净等医保内创新药精准定位未被满足的临床需求，优异的临床数据在实践 中得到广泛验证，临床价值获得医生及患者的持续认可，收入继续保持快 ...

智通财经APP讯，恒瑞医药(01276)公布2025年中期业绩，收入约人民币157.61亿元，较去年同期增长 15.9%;归属于公司股东的净利润人民币44.5亿元，较去年同期增长29.7%;每股基本盈利人民币0.70元。 创新药对外许可作为公司常态化业务，其收入已成为我们营业收入的重要组成部分。报告期内，公司收 到Merck Sharp & Dohme 2亿美元以及 IDEAYA Biosciences 7500万美元的对外许可首付款，并确认为收 入，进一步推动经营业绩指标增长。 此外，尽管纳入集采的仿制药销售收入仍略有下滑，但公司优质仿制产品布比卡因脂质体、美国获批首 仿产品注射用紫杉醇(白蛋白结合型)等报告期内销售收入取得较快增长，带动整体仿製药业务收入实现 小幅提升。 瑞维鲁胺、达尔西利、恒格列净等医保内创新药精准定位未被满足的临床需求，优异的临床数据在实践 中得到广泛验证，临床价值获得医生及患者的持续认可，收入继续保持快速增长。艾瑞昔布、瑞马唑 仑、吡咯替尼及氟唑帕利等上市较早的创新药，随着上市后研究循证医学证据的逐步积累及新适应症的 持续获批，应用範围不断扩大，持续为公司销售收入贡献增量。阿帕替尼、 ...

Core Viewpoint - The company has received FDA approval for the production site transfer of its drug, Idarubicin Hydrochloride Injection, which is crucial for treating acute myeloid leukemia (AML) and is currently in short supply in the U.S. market [2][3] Group 1: FDA Approval and Product Details - Meitheal Pharmaceuticals, a subsidiary of the company, has obtained FDA approval for the production site transfer of Idarubicin Hydrochloride Injection, which comes in three dosages: 5mg/5mL, 10mg/10mL, and 20mg/20mL [2] - The drug is currently only available from one other company in the U.S. as a generic product, highlighting its market significance [2] - The product was acquired from Teva Pharmaceuticals in 2023, and the company plans to produce it at its own oncology drug facility after FDA approval [2] Group 2: Commercialization and Sales Growth - The company is also preparing to commercialize another product, Albumin-bound Paclitaxel, which recently received FDA approval from Double Pharma [3][4] - The company's formulation business has seen nearly a 20% year-on-year increase in sales revenue from the U.S. over the past year, indicating a strong international business growth trajectory [3] Group 3: Strategic Partnerships and Market Potential - The collaboration with Double Pharma for Albumin-bound Paclitaxel is considered the company's largest commercialization partnership, with a total milestone payment of $6 million to be paid by Hong Kong King-Friend Industrial Co., Ltd. [5] - The U.S. market for Albumin-bound Paclitaxel is projected to be in the range of several billion dollars, with the company expecting a significant sales performance once the product is launched [7] Group 4: Internationalization and Market Strategy - The company has established a local commercialization team in the U.S. since 2016, aiming to build a comprehensive supply chain and directly engage with the market [10] - The company is actively expanding its global footprint, with ongoing product registration and sales efforts in over 20 countries, including regions in South America, Asia, North Africa, and Europe [11] Group 5: Regulatory Challenges and Competitive Landscape - The company acknowledges the higher regulatory standards set by the FDA compared to domestic drug approvals, which can pose challenges for Chinese pharmaceutical companies [6] - The company emphasizes its competitive advantages in quality, sales, research, registration, and market capabilities to maintain its bargaining power in the evolving market landscape [11]

Investment Rating - The report does not provide a specific investment rating for the company Core Insights - The company has received approval for its first generic injectable risperidone microsphere, marking a significant breakthrough in high-end formulations. This product is the first of its kind in China and is expected to enhance the company's market position [1][11][16] - The company is advancing multiple high-end formulations, including paclitaxel (albumin-bound) and leuprolide microspheres, with significant market potential. The injectable leuprolide microsphere market in China was valued at RMB 5.1 billion in 2023, while the paclitaxel (albumin-bound) market reached nearly RMB 3 billion [1][19][27] - The company has a strong pipeline of products, with several formulations in various stages of development, indicating a robust growth trajectory in the high-end drug formulation sector [3][29][34] Summary by Sections Product Approvals and Developments - The company announced the approval of injectable risperidone microspheres on February 26, 2025, which is a significant addition to its high-end complex formulations [1][11] - The injectable paclitaxel (albumin-bound) has received acceptance for its market application, and the leuprolide microsphere has passed bioequivalence trials, indicating progress in the company's product pipeline [1][19][26] Financial Performance - The company's main revenue has shown significant growth, with a 113.37% increase in 2023, reaching RMB 460.8 million, although operating losses have continued to widen [4][10] - The company is expected to generate revenue from its newly approved products starting in late 2024, which could positively impact its financial performance [2][29] Market Position and Competitive Advantage - The company has established a competitive edge in the high-end formulation market due to its ability to produce large batches, which translates to cost advantages and increased market share potential [2][29] - The injectable risperidone microsphere is the only product in its category that has passed consistency evaluation and achieved first-generic status, highlighting the company's strong R&D capabilities [16][18] Future Outlook - The company is well-positioned for future growth with a diverse product pipeline and a focus on high-end formulations, which are expected to fill market gaps and drive revenue growth [34][36] - The anticipated market expansion for injectable risperidone microspheres and other formulations suggests a promising outlook for the company's profitability and market presence [18][27]