Workflow
HENGRUI PHARMA(01276)
icon
Search documents
港股异动 | 恒瑞医药(01276)尾盘涨超4% 多款药品获批开展临床试验 近期与Glenmark达成授权合作
智通财经网· 2025-09-30 07:15
Core Viewpoint - Heng Rui Medicine (01276) experienced a significant stock price increase, with a rise of over 4% at the close, and a current price of HKD 87.95, with a trading volume of HKD 217 million [1] Group 1: Clinical Trials and Approvals - Heng Rui Medicine announced the approval to conduct clinical trials for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1] Group 2: Licensing Agreement - The company granted Glenmark, an Indian pharmaceutical company, exclusive rights to develop and commercialize its HER2 antibody-drug conjugate, Trastuzumab deruxtecan, in global non-core markets, receiving an upfront payment of USD 18 million and potential milestone payments exceeding USD 1 billion [1] Group 3: Market Rights and Financial Impact - Nomura's report indicates that Heng Rui retains development and commercialization rights for Trastuzumab deruxtecan in major pharmaceutical markets including Greater China, the US, Canada, Europe, and Japan, suggesting that the upfront payment will have a minimal financial impact, but the overall milestone payment scale could be substantial [1] - The collaboration with Glenmark is expected to help unlock the commercial potential of the product, and retaining rights in key markets provides opportunities for larger-scale partnerships in the future [1]
智通港股通占比异动统计|9月30日
智通财经网· 2025-09-30 00:40
Core Insights - The article highlights significant changes in the stock holdings of various companies under the Hong Kong Stock Connect program, indicating shifts in investor sentiment and potential investment opportunities. Group 1: Stock Increases - Canggang Railway (02169) saw the largest increase in stock holdings, rising by 10.72% to a total holding of 33.06% [1][2] - Goldwind Technology (02208) experienced a 1.17% increase, bringing its holding to 48.64% [1][2] - Zhongchu Innovation (03931) had a 1.02% increase, resulting in a holding of 14.69% [1][2] - The top three companies with the highest increases over the last five trading days were Dazhong Public Utilities (01635) with a 26.45% increase, Canggang Railway (02169) with a 21.07% increase, and Shankao Holdings (00412) with a 12.67% increase [1][3] Group 2: Stock Decreases - Shandong Molong (00568) recorded the largest decrease in stock holdings, dropping by 1.69% to 55.70% [1][2] - Jinli Permanent Magnet (06680) saw a decrease of 1.65%, resulting in a holding of 22.36% [1][2] - Yihua Tong (02402) experienced a 0.89% decrease, bringing its holding to 19.98% [1][2] - Over the last five trading days, the largest decreases were noted for Dongfang Electric (01072) with a 5.93% decrease, Yihua Tong (02402) with a 4.16% decrease, and Ocean Park (02255) with a 2.54% decrease [1][3] Group 3: Long-term Trends - Over the past 20 days, Dazhong Public Utilities (01635) had the highest increase of 27.37%, reaching a holding of 60.02% [4] - Canggang Railway (02169) also saw a significant increase of 21.39%, maintaining a holding of 33.06% [4] - Longfei Optical Fiber and Cable (06869) increased by 17.15%, achieving a holding of 71.17% [4]
港股公告掘金 | 来凯医药-B:I期临床MAD研究取得积极初步结果 LAE102展现出令人鼓舞的增肌减脂趋势
Zhi Tong Cai Jing· 2025-09-29 15:29
Major Events - Lai Kai Pharmaceutical-B (02105) reported positive preliminary results from Phase I clinical MAD study, with LAE102 showing encouraging trends in muscle gain and fat loss [1] - Fuhong Hanlin (02696) received FDA approval for the Phase I clinical trial application of HLX13 for first-line treatment of unresectable hepatocellular carcinoma (HCC) patients [1] - Ningmeng Media (09857) has commenced filming the urban medical emotional drama "Asking Heart 2" [1] - CRRC Corporation (01766) and its subsidiaries signed significant contracts totaling approximately 54.34 billion [1] - Heng Rui Pharmaceutical (01276) received approval to conduct clinical trials for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1] - Hema Medical (03309) entered into a tripartite global licensing and collaboration agreement with Gilead and Hanmi regarding enecuidar [1] - Jinfang Pharmaceutical-B (02595) completed the enrollment of the first patient in the Phase I/II clinical trial of the molecular glue Pan RAS(ON) inhibitor GFH276 for RAS mutant cancer patients [1] - Gao Shi Medical (02407) obtained international certification for its medical device quality management system [1] Operating Performance - Shenzhen Expressway Company (00548) reported toll revenue of 114 million for the Outer Ring project in August [1] - China National Automobile (00026) announced an annual performance with a post-tax loss attributable to shareholders of 185 million HKD, a year-on-year reduction of 29.64% [1] - OKURA HOLDINGS (01655) reported an annual profit attributable to shareholders of 1.342 billion JPY, a year-on-year decrease of 34.34% [1] - Elephant Future Group (02309) disclosed an annual performance with a loss attributable to owners of approximately 314 million HKD, a year-on-year increase of 71.77% [1] - Henghe Group (00513) reported an annual performance with a loss attributable to owners of approximately 259 million HKD, a year-on-year increase of 0.7% [1]
恒瑞医药(01276):SHR-7787 注射液、SHR-4849 注射液、贝伐珠单抗注射液、阿得贝利单抗注射液获批开展临床试验
智通财经网· 2025-09-29 10:39
Core Insights - 恒瑞医药's subsidiaries have received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: SHR-7787 and SHR-4849 - SHR-7787 is a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs approved in China to date. The total R&D investment for SHR-7787 is approximately 48.93 million yuan [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with no similar drugs approved in China or abroad. The total R&D investment for SHR-4849 is approximately 69.67 million yuan [1] Group 2: Bevacizumab and Adebali Monoclonal Antibody - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was approved in the U.S. in 2004 and has generated global sales of approximately 5.655 billion USD in 2024. The total R&D investment for Bevacizumab by the company is approximately 348.89 million yuan [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer. The total R&D investment for Adebali is approximately 939.08 million yuan, with similar products generating combined global sales of approximately 9.648 billion USD in 2024 [2]
恒瑞医药(01276.HK)子公司获SHR-7787注射液、SHR-4849注射液、贝伐珠单抗注射液、阿得贝利单抗注射液的药物临床试验批准通知书
Ge Long Hui· 2025-09-29 10:39
Core Viewpoint - Recently, Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiaries have received approval from the National Medical Products Administration for clinical trials of several injection drugs, indicating progress in their oncology drug development pipeline [1]. Group 1: Clinical Trial Approvals - Hengrui Medicine's subsidiaries, including Suzhou Sediya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have received clinical trial approval notices for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1]. - The approved drugs will undergo clinical trials, with SHR-7787 injection being tested in a multicenter, open-label Phase II study in patients with malignant solid tumors [1]. Group 2: Regulatory Compliance - The approved drugs were reviewed and found to meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China, allowing for the commencement of clinical trials [1]. - The approval date for the drugs was noted as July 17, 2025, indicating a timeline for the regulatory process [1].
恒瑞医药(01276)子公司获国家药监局核准签发HRS-2129片的《药物临床试验批准通知书》
智通财经网· 2025-09-29 10:33
HRS-2129 片拟用于治疗急慢性疼痛。经查询,目前国内尚无同靶点药物获批上市。截至目前,HRS- 2129片相关项目累计研发投入约为1.12亿元。 智通财经APP讯,恒瑞医药(01276)发布公告,近日,公司子公司山东盛迪医药有限公司、上海恒瑞医药 有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于HRS-2129片的《药物临床试验 批准通知书》,将于近期开展临床试验。 ...
恒瑞医药(01276.HK)子公司获HRS-2129片的药物临床试验批准通知书
Ge Long Hui· 2025-09-29 10:32
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-2129 tablets, which are intended for the treatment of diabetic peripheral neuropathic pain and osteoarthritis pain in adults [1] Group 1: Drug Information - Drug Name: HRS-2129 tablets [1] - Dosage Form: Tablet [1] - Clinical Trial Acceptance Numbers: CXHL2500661, CXHL2500662, CXHL2500663, CXHL2500664 [1] - Approval Conclusion: The drug meets the requirements for drug registration and is approved for clinical trials [1] Group 2: Market Context - HRS-2129 tablets are aimed at treating acute and chronic pain [1] - Currently, there are no approved drugs targeting the same mechanism in the domestic market [1] - Cumulative R&D investment for HRS-2129 tablets is approximately 112 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
2025-09-29 10:24
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。 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。 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9月29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。 ᵜޜਨ㪓һՊ৺ޘփ㪓һ؍䇱ᵜޜᇩнᆈ൘ԫօ㲊ۇٴ䇠䖭ǃ䈟ሬᙗ䱸䘠 ᡆ㘵䟽 ...
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
2025-09-29 10:19
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) (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。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-154 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司(以下简称"公司")子公司山东盛迪医 药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局(以下简称"国家 药监局")核准签发关于 HRS-2129 片的《药物临床试验批准通知书》,将于近 期开展临床试验。现将相关情况公告如下: 根據中華人民共和國的 ...
恒瑞医药(01276)9月29日耗资约7370.23万元回购108万股A股
智通财经网· 2025-09-29 08:54
智通财经APP讯,恒瑞医药(01276)公布,2025年9月29日耗资约7370.23万元回购108万股A股股份。 ...