HENGRUI PHARMA(01276)
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恒瑞医药(01276):SHR-2906注射液获得药物临床试验批准通知书
智通财经网· 2025-12-19 12:17
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SHR-2906 injection, a self-developed therapeutic biological product aimed at treating overweight and obesity [1] Group 1: Product Development - SHR-2906 injection is designed to regulate glucose and lipid metabolism, control weight, and improve the metabolic environment in the body [1] - The product is expected to have a synergistic effect in reducing energy intake and promoting energy expenditure [1] - Currently, there are no similar drugs approved for market use domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-2906 injection project has reached approximately 17.06 million yuan [1]
恒瑞医药(01276.HK):子公司“SHR-9539注射液”及“HRS-3738片”获药物临床试验批准
Ge Long Hui· 2025-12-19 12:11
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9539 injection and HRS-3738 tablets, indicating progress in their drug development pipeline [1] Group 1: Clinical Trial Approval - Jiangsu Heng Rui Medicine Co., Ltd. and its subsidiaries have been granted the Clinical Trial Approval Notice for SHR-9539 injection and HRS-3738 tablets [1] - The approval is based on the review under the Drug Administration Law of the People's Republic of China, confirming that the drugs meet the registration requirements [1] - The specific study involves a Phase I/II trial of SHR-9539 in combination therapy for multiple myeloma [1]
恒瑞医药(01276.HK):北京盛迪“SHR-2906注射液”获药物临床试验批准
Ge Long Hui· 2025-12-19 12:11
Group 1 - The core point of the article is that Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-2906 injection, which will soon commence [1][2] Group 2 - Drug Name: SHR-2906 Injection [2] - Dosage Form: Injection [2] - Application Matter: Clinical Trial [2] - Acceptance Number: CXSL2500799 [2] - Approval Conclusion: The clinical trial application for SHR-2906 injection, accepted on September 17, 2025, meets the requirements for drug registration and is approved to conduct clinical trials for overweight or obesity [2]
恒瑞医药(01276): HRS-6208 胶囊、HRS-6209 胶囊、HRS-8080 片、HRS-1358 片、HRS-5041 片获批开展临床试验
智通财经网· 2025-12-19 12:08
Core Viewpoint - The company, Heng Rui Medicine, has received approval from the National Medical Products Administration for clinical trials of five new drug candidates, indicating a significant advancement in its oncology pipeline [1][2][3]. Group 1: Drug Candidates Overview - HRS-6208 is a novel, highly selective small molecule inhibitor that effectively suppresses phosphorylation activation of its target, impacting cell cycle and transcriptional activity to inhibit tumor cell proliferation. No similar products have been approved in the market, with a cumulative R&D investment of approximately 38.14 million yuan [1]. - HRS-6209 is a selective CDK4 inhibitor that induces tumor cell arrest in the G1 phase, aimed at treating advanced malignant solid tumors. It shows improved selectivity over CDK6/cyclinD3 pathways compared to existing CDK4/6 inhibitors, with a cumulative R&D investment of about 119.85 million yuan [2]. - HRS-8080 is a novel oral selective estrogen receptor degrader (SERD) designed to degrade ER and inhibit its activity, targeting ER-positive and ER-mutated breast cancer. The cumulative R&D investment for this project is around 198.70 million yuan [2]. - HRS-5041 is a new, highly selective AR PROTAC molecule intended for prostate cancer treatment, demonstrating significant degradation of wild-type and most mutant AR proteins, with a cumulative R&D investment of approximately 92.66 million yuan [3]. - HRS-1358 is a targeted estrogen receptor (ER) degrading PROTAC molecule that can overcome resistance due to target protein mutations, with a cumulative R&D investment of about 96.01 million yuan [3].
恒瑞医药(01276.HK):注射用醋酸亮丙瑞林微球获药物临床试验批准
Ge Long Hui· 2025-12-19 12:07
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]
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-12-19 12:06
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 孫飄揚先生 中國上海 2025年12月19日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-205 (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董 ...
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-12-19 12:02
Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年12月19日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告 ...
恒瑞医药(01276):注射用醋酸亮丙瑞林微球获批开展临床试验
智通财经网· 2025-12-19 12:01
Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of injectable acetic acid leuprolide microspheres, which will be conducted shortly [1] Group 1: Product Information - Acetic acid leuprolide is a GnRH analog used for the treatment of prostate cancer [1] - The original research product LEUPLIN®Pro was developed by Takeda Pharmaceutical Company and was approved for market in Japan in November 2015, but has not yet been launched domestically [1] - The dosage and administration of the injectable acetic acid leuprolide microspheres differ from the already marketed injectable leuprolide microspheres in China, making it a generic version of an overseas product that has not been launched domestically [1] Group 2: Financial Investment - The total research and development investment for the injectable acetic acid leuprolide microspheres project has reached approximately 24.68 million yuan [1]
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-12-19 11:59
Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-203 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年12月19日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先 ...
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-12-19 11:55
Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年12月19日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-202 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 ...