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恒瑞医药子公司HRS-7535片获得药物临床试验批准通知书
智通财经网· 2026-01-12 10:19
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-7535 tablets, which will be conducted soon. The drug is intended for the treatment of hypertension combined with overweight or obesity [2] Group 1: Product Development - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist that activates human GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [2] - The drug also enhances satiety and suppresses appetite through central mechanisms, directly reducing energy intake, making it suitable for treating type 2 diabetes (T2DM) and weight loss [2] - There are currently no oral small molecule GLP-1 receptor agonists available on the global market [2] Group 2: Financial Investment - The cumulative research and development investment for the HRS-7535 project has reached approximately 36.94 million yuan [2]
恒瑞医药子公司注射用SHR-1826纳入突破性治疗品种名单
Zhi Tong Cai Jing· 2026-01-12 10:19
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the National Medical Products Administration's list of breakthrough therapies, targeting a specific type of lung cancer [1] Group 1 - The indication for SHR-1826 is for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer that has c-Met overexpression (2-3+, ≥50%) and has failed at least one line of systemic therapy [1]
恒瑞医药HRS-7535片临床试验获批
Bei Jing Shang Bao· 2026-01-12 10:17
Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will commence shortly [1] Group 1: Product Information - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist designed to treat type 2 diabetes (T2DM) and aid in weight loss [1] - The mechanism of HRS-7535 includes activating GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [1] - Additionally, HRS-7535 influences the central nervous system to enhance satiety and suppress appetite, leading to a direct reduction in energy intake [1]
恒瑞医药(600276.SH)子公司HRS-7535片获得药物临床试验批准通知书
智通财经网· 2026-01-12 10:12
Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will be conducted soon. The indication for this product is intended for the treatment of hypertension combined with overweight or obesity [1] Group 1 - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist that promotes insulin secretion from the pancreas and reduces glucagon secretion while inhibiting gastric emptying through the activation of human GLP-1R [1] - The drug also enhances satiety and suppresses appetite through central mechanisms, directly reducing energy intake, making it suitable for the treatment of type 2 diabetes (T2DM) and weight loss [1] - There are currently no oral small molecule GLP-1 receptor agonists available in the global market [1] Group 2 - The cumulative research and development investment for HRS-7535 tablets has reached approximately 369.4 million yuan [1]
恒瑞医药(600276.SH)子公司注射用SHR-1826纳入突破性治疗品种名单
智通财经网· 2026-01-12 10:12
Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapies by the National Medical Products Administration's Drug Evaluation Center [1] Group 1 - The indication for SHR-1826 is proposed for monotherapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have failed at least one line of systemic therapy and have c-Met overexpression (2-3+, ≥50%) [1]
恒瑞医药注射用SHR-1826纳入突破性治疗品种名单
Bei Jing Shang Bao· 2026-01-12 10:11
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the National Medical Products Administration's list of breakthrough therapies, targeting a specific type of lung cancer [1] Group 1 - The indication for SHR-1826 is for monotherapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have previously failed at least one line of systemic therapy [1] - The targeted patient population has c-Met overexpression (2-3+, ≥50%) [1]
恒瑞医药(600276) - 恒瑞医药关于药物纳入突破性治疗品种名单的公告
2026-01-12 09:30
受理号:CXSL2300466 证券代码:600276 证券简称:恒瑞医药 公告编号:临2026-008 江苏恒瑞医药股份有限公司 关于药物纳入突破性治疗品种名单的公告 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")子公司苏州盛迪亚生 物医药有限公司的注射用SHR-1826被国家药品监督管理局药品审评中心(以下简 称"药审中心")纳入突破性治疗品种名单。现将相关情况公告如下: 一、药物的基本情况 药物名称:注射用SHR-1826 药物类型:治疗用生物制品 注册分类:1类 申请日期:2025年12月1日 拟定适应症(或功能主治):单药治疗既往接受过至少一线系统性治疗失败 的c-Met过表达(2-3+,≥50%)驱动基因阴性局部晚期或转移性非鳞状非小细胞 肺癌。 理由及依据:经审核,本申请符合《药品注册管理办法》和《国家药监局关 于发布<突破性治疗药物审评工作程序(试行)>等三个文件的公告》(2020年 第82号)有关要求,同意纳入突破性治疗药物程序。 二、药物的其他相关情况 肺 ...
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
2026-01-12 09:30
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-007 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。 二、药物的其他情况 HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动 剂,既可以通过激活人的 GLP-1R,促进胰腺的胰岛素分泌和降低胰高血糖素分 泌并抑制胃排空,还可以通过影响中枢增强饱腹感和抑制食欲,直接减少能量的 摄入等机制用于治疗 2 型糖尿病(T2DM)和减重。全球范围内尚无口服小分子 GLP-1R 激动剂上市。截至目前,HRS-7535 片相关项目累计研发投入约 36,940 万元。 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 ...
扎推港股IPO,一场阳谋
虎嗅APP· 2026-01-12 09:23
Group 1 - The core viewpoint of the article highlights a surge in IPO activity on the Hong Kong Stock Exchange (HKEX) at the beginning of 2026, driven by a wave of hard-tech companies seeking funding amidst cash flow challenges [2][4]. - Notable IPOs include companies like Wallen Technology, which saw a first-day surge of 94.59%, and several others in the AI and biotech sectors listing within a short timeframe [2][3]. - The article discusses the financial pressures faced by these companies, with significant losses reported in 2025, such as Wallen's loss of 1.6 billion and Zhipu's loss of 2.36 billion, highlighting the urgent need for capital [8][6]. Group 2 - The article explains that the relatively lower listing requirements on HKEX compared to other exchanges, such as the STAR Market and the ChiNext, make it an attractive option for startups [10][11]. - The presence of foreign investment and the ability to navigate complex ownership structures, such as VIE, further incentivize companies to choose HKEX for their IPOs [13][12]. - The article also notes that the HKEX is becoming a strategic battleground in the US-China tech and capital competition, with a significant portion of global dollar liquidity being redirected to Hong Kong [23][24]. Group 3 - The liquidity premium in the biotech sector is emphasized, as HKEX allows companies without commercial revenue to list, which is more favorable compared to A-share requirements [15][22]. - The article illustrates how foreign funds view business development (BD) differently, focusing on the potential for overseas licensing deals rather than just domestic sales, which influences valuation positively [21][20]. - The influx of quality assets and growth potential in HKEX is expected to enhance liquidity and attract more international capital, suggesting a bullish outlook for the Hong Kong market in 2026 [29][28].
恒瑞医药:HRS-7535片获得药物临床试验批准通知书
Ge Long Hui· 2026-01-12 09:17
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-7535 tablets, a new oral small molecule GLP-1 receptor agonist aimed at treating type 2 diabetes and weight loss [1]. Company Summary - The subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. of Heng Rui Medicine is set to initiate clinical trials for HRS-7535 tablets shortly [1]. - HRS-7535 functions by activating GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [1]. - The drug also enhances satiety and suppresses appetite through central mechanisms, leading to a direct reduction in energy intake [1]. Industry Summary - The development of GLP-1 receptor agonists is significant in the treatment landscape for type 2 diabetes (T2DM) and obesity, addressing both metabolic control and weight management [1].