Hengrui Pharma(600276)
Search documents
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 ...
泡泡玛特,逆市大涨!医药巨头,突传利好
Zhong Guo Ji Jin Bao· 2026-01-20 11:00
Group 1 - The core point of the news is that Pop Mart's stock surged over 9% due to a share buyback and positive outlook from Morgan Stanley, while the overall Hong Kong market experienced a decline [1][5][6] - Pop Mart's share price increased by 9.07%, closing at HKD 197.20 per share, with a trading volume of HKD 58.79 billion, ranking fourth among Hang Seng Index constituents [5][6] - The company repurchased 1.4 million shares on January 19 at a total cost of HKD 251 million, with plans to cancel the repurchased shares [5][6] Group 2 - Morgan Stanley's report predicts Pop Mart's net profit for 2025 to be RMB 12.6 billion, with an expected cash reserve of RMB 20 billion by the end of 2025, indicating strong financial resources for shareholder returns [6] - Heng Rui Medicine announced the approval of clinical trials for its new drug HRS-2141, aimed at treating type 2 diabetes, marking a significant step in its drug development pipeline [7][10] - The drug HRS-2141 is a fixed-dose combination formulation, with no similar drugs approved in the domestic and international markets, and the company has invested approximately RMB 5.4 million in its development so far [10][11]
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]
恒瑞医药(600276) - 恒瑞医药关于获得药物临床试验批准通知书的公告

2026-01-20 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-010 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 HRS-4642 注射液能特异性结合 KRAS G12D,抑制 MEK、ERK 蛋白的磷酸化,发挥 抗肿瘤作用。经查询,目前国内外尚无同类药物获批上市。截至目前,HRS-4642 注射液相关项目累计研发投入约 25,420 万元(未经审计)。 三、风险提示 根据我国药品注册相关的法律法规要求,药物在获得药物临床试验批准通知 书后,尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药品 从研制、临床试验报批到投产的周期长、环节多,药品研发及至上市容易受到一 些不确定性因素的影响,敬请广大投资者谨慎决策,注意防范投资风险。公司将 按国家有关规定积极推进上述研发项目,并及时对项目后续进展情况履行信息披 露义务。 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")及子公司苏州盛迪 亚生物医药有限公司、上海恒瑞医药有限公司收到国家药品监督管理 ...
恒瑞医药(600276) - 恒瑞医药关于获得药物临床试验批准通知书的公告

2026-01-20 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-009 一、药物的基本情况 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-2141 片(Ⅰ)、(Ⅱ)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: 药物名称:HRS-2141 片(Ⅰ)、(Ⅱ) 剂 型:片剂 申请事项:临床试验 受 理 号:CXHL2501153、CXHL2501154 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025 年 10 月 21 日受理的 HRS-2141 片(Ⅰ)、(Ⅱ)符合药品注册的有关要求,同 意开展 2 型糖尿病适应症的临床试验。 二、药物的其他情况 HRS-2141 片(Ⅰ)、(Ⅱ)是固定剂量复方制剂,通过药理机制互补协同 降血糖。经查询,目前国内外尚无同类药物获 ...
A股重磅!宽基ETF连续出现净赎回,有“巨无霸”份额回落至“924”行情之前,多只科创、创业板系ETF份额缩水,发生了啥?
Jin Rong Jie· 2026-01-20 08:57
Group 1 - Recent net redemptions in A-share broad-based ETFs have drawn market attention, with significant outflows recorded on January 15 and 16, totaling 687 billion and 863 billion respectively, marking the highest single-day outflows in history [1] - As of January 19, four out of six major broad-based ETFs saw their shares decline by over 10% in the last three trading days, with the largest, Huatai-PB CSI 300 ETF, dropping to 778.63 billion shares, a scale of approximately 369.2 billion, the lowest since August 2024 [1] - The ChiNext and STAR Market ETFs also experienced significant declines, with the E Fund STAR 50 ETF and E Fund ChiNext ETF seeing share reductions of 34.55% and 20.22% respectively [3] Group 2 - In contrast to the outflows from broad-based ETFs, certain commodity, cross-border, and narrow-based ETFs attracted significant inflows, with the Southern Nonferrous ETF being the only product to receive over 10 billion in net inflows, totaling 100.87 billion, driven by rising base metal prices [3] - Other ETFs such as Yongying Satellite ETF, Harvest Software ETF, and GF Media ETF also received net inflows exceeding 6 billion [3] - According to CITIC Securities, the impact of ETF redemptions on individual stocks was significant, with main board, ChiNext, and STAR Market stocks experiencing sell-offs of 946 billion, 334 billion, and 265 billion respectively during the peak outflow days [3] Group 3 - Regulatory measures have been implemented to cool down the market following rapid price increases and overheated sentiment, including raising the minimum margin requirement for margin trading from 80% to 100% [5][6] - The China Securities Regulatory Commission emphasized the need for comprehensive market monitoring and timely counter-cyclical adjustments to maintain market stability and prevent excessive volatility [6] - There are differing views on the long-term outlook for A-shares, with some analysts suggesting the potential for a slow bull market due to reforms, while others remain skeptical about escaping historical volatility patterns [7]
恒瑞医药:HRS-2141片获准开展2型糖尿病适应症的临床试验,目前国内外尚无同类药物获批上市
Mei Ri Jing Ji Xin Wen· 2026-01-20 08:56
Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HRS-2141 tablets for type 2 diabetes, marking a significant step in its drug development pipeline [1] Group 1: Drug Development - HRS-2141 is a fixed-dose combination formulation that utilizes complementary pharmacological mechanisms to lower blood sugar levels [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] Group 2: Regulatory Approval - The approval includes the issuance of a "Clinical Trial Approval Notice" for phases I and II of the drug [1] - This regulatory milestone is crucial for the advancement of the drug towards potential market entry [1]
恒瑞医药:HRS-2141片获准开展2型糖尿病适应症的临床试验
Xin Lang Cai Jing· 2026-01-20 08:52
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 company's drug development efforts [1] Group 1: Drug Development - HRS-2141 is a fixed-dose combination formulation that utilizes complementary pharmacological mechanisms to lower blood sugar levels [1] - Currently, there are no similar drugs approved for market release domestically or internationally, indicating a potential competitive advantage for the company [1] Group 2: Regulatory Approval - The approval includes a clinical trial notification for both phases I and II, allowing the company to advance its research and development process [1] - The regulatory approval is a critical milestone that may enhance investor confidence in the company's future prospects [1] Group 3: Market Considerations - The development and market introduction of the drug may face uncertainties, which necessitates cautious decision-making from investors [1]