Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of its injectable leuprolide acetate microspheres, indicating a significant step in its product development pipeline [1] Group 1 - The company’s subsidiary, Shanghai Heng Rui Medicine Co., Ltd., is set to initiate clinical trials for the new drug [1] - The approval marks a crucial milestone in the company's efforts to expand its product offerings in the pharmaceutical market [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its injectable Leuprolide Acetate Microspheres, targeting prostate cancer treatment [1] Drug Information - Drug Name: Injectable Leuprolide Acetate Microspheres [1] - Dosage Form: Injectable [1] - Application Matter: Clinical Trial [1] - Acceptance Number: CYHL2500159 [1] - Approval Conclusion: The clinical trial application for Injectable Leuprolide Acetate Microspheres, accepted on August 29, 2025, meets the requirements for drug registration and is approved to conduct clinical trials for prostate cancer [1]

据悉，醋酸亮丙瑞林是 GnRH 类似物，用于治疗前列腺癌。塬研产品 LEUPLIN Pro 由武田药品工业株 式会社开发，2015 年 11 月获日本 PMDA 批准上市，尚未在国内上市。本品用法用量与中国已上市的 注射用亮丙瑞林微球不同，属仿制境外已上市但境内未上市的原研药品。截至目前，注射用醋酸亮丙瑞 林微球相关项目累计研发投入约 2,468 万元。 恒瑞医药（600276）(01276)公布，近日，公司子公司上海恒瑞医药有限公司收到国家药品监督管理局 核准签发关于注射用醋酸亮丙瑞林微球的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

据悉，醋酸亮丙瑞林是 GnRH 类似物，用于治疗前列腺癌。塬研产品 LEUPLIN®Pro 由武田药品工业株 式会社开发，2015 年 11 月获日本 PMDA 批准上市，尚未在国内上市。本品用法用量与中国已上市的 注射用亮丙瑞林微球不同，属仿制境外已上市但境内未上市的原研药品。截至目前，注射用醋酸亮丙瑞 林微球相关项目累计研发投入约 2,468 万元。 智通财经APP讯，恒瑞医药(01276)公布，近日，公司子公司上海恒瑞医药有限公司收到国家药品监督管 理局核准签发关于注射用醋酸亮丙瑞林微球的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

公告显示，醋酸亮丙瑞林是GnRH类似物，用于治疗前列腺癌。原研产品LEUPLIN Pro由武田药品工业 株式会社开发，2015年11月获日本PMDA批准上市，尚未在国内上市。本品用法用量与中国已上市的注 射用亮丙瑞林微球不同，属仿制境外已上市但境内未上市的原研药品。 北京商报讯(记者王寅浩宋雨盈)12月19日，恒瑞医药（600276）发布公告称，公司子公司上海恒瑞医药 有限公司收到国家药品监督管理局核准签发关于注射用醋酸亮丙瑞林微球的《药物临床试验批准通知 书》，同意该品开展前列腺癌的临床试验。 ...

醋酸亮丙瑞林是GnRH类似物,用于治疗前列腺癌。原研产品LEUPLIN®Pro由武田药品工业株式会社开 发,2015年11月获日本PMDA批准上市,尚未在国内上市。本品用法用量与中国已上市的注射用亮丙瑞林 微球不同,属仿制境外已上市但境内未上市的原研药品。截至目前,注射用醋酸亮丙瑞林微球相关项目累 计研发投入约2468万元。 格隆汇12月19日丨恒瑞医药(600276.SH)公布,近日,公司子公司上海恒瑞医药有限公司收到国家药监局核 准签发关于注射用醋酸亮丙瑞林微球的《药物临床试验批准通知书》,将于近期开展临床试验。 ...

Group 1: Drug Development Announcement - Hunan Fangsheng Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., received the Clinical Trial Approval Notice for the drug RuLuGoli Tablets from the National Medical Products Administration [1][2] - RuLuGoli Tablets are a GnRH receptor antagonist intended for the treatment of advanced prostate cancer [2] - The cumulative R&D investment for this drug project is approximately 3.89 million yuan (unaudited) [3] Group 2: Market Situation - The original drug for RuLuGoli Tablets was developed by Takeda Pharmaceutical Company and was first approved for sale in Japan on January 8, 2019 [4] - As of the announcement date, RuLuGoli Tablets have not yet been launched in China, and no original or generic products have been approved for sale [4] - In 2023, the global sales amount for RuLuGoli Tablets reached approximately $29.96 million, with a year-on-year growth rate of 58.6% [4] Group 3: Approval Process - After receiving the Clinical Trial Approval Notice, the company must conduct and complete clinical trials and submit the application for product listing according to the relevant regulations [5] Group 4: Share Pledge Announcement - The controlling shareholder, Zhang Qinghua, completed the pledge of 35 million shares (7.97% of the total share capital) on October 15, 2025 [8][9] - As of the announcement date, Zhang Qinghua directly holds 156,019,500 shares, accounting for 35.53% of the total shares [8] - The pledged shares do not exceed 80% of the total shares held, indicating that the overall pledge risk is controllable [8][12]

Core Viewpoint - Shanghai Heng Rui Medicine Co., Ltd. has received acceptance for the clinical trial application of Leuprolide Acetate Microspheres, a Class 3 chemical drug, which has already surpassed annual sales of 5 billion yuan in the domestic market [1][4]. Group 1: Market Overview - Leuprolide Acetate is a synthetic peptide analog of gonadotropin-releasing hormone (GnRH), primarily used for treating diseases related to elevated sex hormone levels, such as endometriosis, uterine fibroids, precocious puberty, prostate cancer, and breast cancer [3]. - The domestic market for Leuprolide Acetate has shown stable sales exceeding 5 billion yuan over the past three years, with sales figures of 5.206 billion yuan in 2022, 5.391 billion yuan in 2023, and projected 5.623 billion yuan in 2024, indicating a steady growth trend [4][6]. Group 2: Competitive Landscape - The original manufacturer, Takeda, and AbbVie developed the injectable Leuprolide Acetate microspheres, which were approved by the FDA in 1989 and have achieved significant success. In China, it was approved in 2000 and is included in the national medical insurance category B [6]. - Currently, there are two domestic companies, Lijun Group and Beijing Bont Pharmaceutical, that hold production licenses for Leuprolide Acetate long-acting microspheres, with Lijun Group being the first to obtain approval for the generic version [8][10]. - The sales share of Lijun Pharmaceutical's Leuprolide Acetate microspheres is the highest at 39.85%, followed by the original manufacturer Takeda [10]. Group 3: Future Market Potential - The market for injectable Leuprolide Acetate microspheres is expected to reach 6.8 billion yuan by 2025 and exceed 8.7 billion yuan by 2030, indicating a promising outlook for the product [6]. - The domestic market for microsphere formulations has grown significantly, with sales increasing from 2.5 billion yuan in 2015 to 7.9 billion yuan in 2023, and the market share rising from 34.6% to 49.7% [13][15]. - As the technology for microsphere formulations matures and pharmaceutical companies continue to innovate, Leuprolide Acetate microspheres are expected to play a crucial role in building competitive advantages and capturing market share [17].

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]