HENGRUI PHARMA(01276)
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恒瑞医药(01276.HK):注射用SHR-9839(sc)、HRS-4642注射液获临床试验批准
Ge Long Hui· 2026-01-20 11:37
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [1] Group 1: SHR-9839 - SHR-9839 is a humanized antibody drug developed by the company, intended for the treatment of advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [1] - The total R&D investment for the SHR-9839 project has reached approximately 93.9 million yuan (unaudited) [1] Group 2: HRS-4642 - HRS-4642 is a KRASG12D inhibitor developed by the company, formulated as a liposome injection [1] - HRS-4642 specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [1] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [1] - The total R&D investment for the HRS-4642 project has reached approximately 254.2 million yuan (unaudited) [1]
恒瑞医药(01276):HRS-2141片(Ⅰ)、(Ⅱ)获药物临床试验批准通知书
智通财经网· 2026-01-20 11:35
Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-2141 tablets (I) and (II), which will commence shortly [1] Group 1 - HRS-2141 tablets (I) and (II) are fixed-dose combination formulations designed to synergistically lower blood glucose through complementary pharmacological mechanisms [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - As of the date of the announcement, the cumulative research and development investment for this drug project is approximately 5.4 million yuan (unaudited) [1]
恒瑞医药:HRS-2141片(Ⅰ)、(Ⅱ)获药物临床试验批准通知书
Zhi Tong Cai Jing· 2026-01-20 11:33
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of HRS-2141 tablets (I) and (II), which will commence shortly [1] Group 1: Product Development - HRS-2141 tablets (I) and (II) are fixed-dose combination formulations designed to synergistically lower blood sugar through complementary pharmacological mechanisms [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - As of the date of the announcement, the cumulative research and development investment for this drug project amounts to approximately 5.4 million yuan (unaudited) [1]
恒瑞医药:注射用SHR-9839(sc)、HRS-4642注射液药物临床试验获批
智通财经网· 2026-01-20 11:33
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [2] Group 1: Clinical Trial Approvals - The company and its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. have been granted a clinical trial approval notice for SHR-9839 and HRS-4642 [2] - SHR-9839 will undergo an open-label, multi-center Phase I/II clinical study to evaluate its safety, tolerability, and efficacy in patients with advanced colorectal cancer [2] Group 2: Drug Development Details - SHR-9839 is a humanized antibody drug developed by the company, aimed at treating advanced solid tumors by blocking two key signaling pathways related to tumor development [2] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [2] - The total R&D investment for SHR-9839 has reached approximately 93.9 million yuan (unaudited) [2] Group 3: HRS-4642 Injection - HRS-4642 injection specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [2] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [2] - The total R&D investment for HRS-4642 has reached approximately 254.2 million yuan (unaudited) [2]
恒瑞医药(01276.HK):子公司“HRS-2141片(Ⅰ)、(Ⅱ)”获药物临床试验批准
Ge Long Hui· 2026-01-20 11:31
Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of HRS-2141 tablets for type 2 diabetes [1] Group 1: Company Announcement - Jiangsu Heng Rui Medicine Co., Ltd.'s subsidiary, Shandong Shengdi Medicine Co., Ltd., has been granted a clinical trial approval notice for HRS-2141 tablets (I) and (II) [1] - The approval allows the company to conduct clinical trials for the drug targeting type 2 diabetes [1] - The acceptance numbers for the clinical trial applications are CXHL2501153 and CXHL2501154 [1] Group 2: Regulatory Details - The approval conclusion states that HRS-2141 tablets (I) and (II) meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - The clinical trials are set to commence following the approval, which was granted based on a review conducted on October 21, 2025 [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

2026-01-20 11:28
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) 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。 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 2026年1月20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 2026-01 ...
恒瑞医药HRS-2141片临床试验获批
Bei Jing Shang Bao· 2026-01-20 11:25
Core Viewpoint - Heng Rui Medicine's subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of HRS-2141 tablets for type 2 diabetes, marking a significant step in the development of a novel treatment option in the market [1] Group 1 - The approved clinical trial is for HRS-2141 tablets (I) and (II), which are fixed-dose combination formulations [1] - The pharmacological mechanism of HRS-2141 is designed to complement and synergistically lower blood sugar levels [1] - Currently, there are no similar drugs approved for marketing in both domestic and international markets [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

2026-01-20 11:24
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。 (股份代號:1276) 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) 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。 中國上海 2026年1月20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 2026-009 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公 ...
恒瑞医药:公司获批两款药物临床试验将开展
Hua Er Jie Jian Wen· 2026-01-20 09:43
Core Viewpoint - The company and its subsidiary have received approval from the National Medical Products Administration for two drug clinical trial notifications, which will commence shortly [1] Drug Details - **Injection SHR-9839 (sc)** - Indication: Advanced colorectal cancer - Mechanism: Humanized antibody that simultaneously blocks two key tumor signaling pathways - Progress: Initiating Phase Ib/II clinical study in combination with anti-tumor therapy - Competitive Landscape: One drug targeting the same pathway has been approved globally - Cumulative R&D Investment: Approximately 93.9 million [1] - **HRS-4642 Injection** - Indication: KRAS G12D mutation tumors - Mechanism: KRAS G12D inhibitor (liposome formulation) - Competitive Landscape: No similar drugs have been approved for marketing domestically or internationally - Cumulative R&D Investment: Approximately 254.2 million [1]
恒瑞医药:收到药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2026-01-20 09:25
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of multiple drug candidates, indicating progress in its research and development pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have received approval for clinical trials of SHR-9839 (sc) and HRS-4642 injection [1] - The subsidiary Shandong Shengdi Medicine Co., Ltd. has also received approval for clinical trials of HRS-2141 tablets (I) and (II) [1]