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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].
恒瑞医药:药物注射用SHR-1826纳入突破性治疗品种名单
Ge Long Hui· 2026-01-12 09:16
格隆汇1月12日丨恒瑞医药(600276.SH)公布,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(称"药审中心")纳入突破性治疗品种名单。 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。 ...
恒瑞医药(600276.SH):HRS-7535片获得药物临床试验批准通知书
Ge Long Hui A P P· 2026-01-12 09:11
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]. Group 1: Product Development - The clinical trial approval for HRS-7535 tablets will allow the company to initiate trials in the near future [1]. - HRS-7535 functions by activating GLP-1 receptors, which promotes insulin secretion from the pancreas, reduces glucagon secretion, and inhibits gastric emptying [1]. - The drug also enhances satiety and suppresses appetite through central mechanisms, leading to reduced energy intake [1]. Group 2: Market Implications - The introduction of HRS-7535 could provide a new treatment option for type 2 diabetes (T2DM) patients, addressing both glycemic control and weight management [1].
恒瑞医药(600276.SH):药物注射用SHR-1826纳入突破性治疗品种名单
Ge Long Hui A P P· 2026-01-12 09:11
格隆汇1月12日丨恒瑞医药(600276.SH)公布,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(称"药审中心")纳入突破性治疗品种名单。 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。 ...
恒瑞医药:子公司HRS - 7535片获药物临床试验批准
Xin Lang Cai Jing· 2026-01-12 09:06
恒瑞医药公告称,子公司山东盛迪医药收到国家药监局关于HRS - 7535片的《药物临床试验批准通知 书》,将于近期开展临床试验。该药物拟用于高血压合并超重或肥胖治疗,是新型口服小分子胰高血糖 素样肽 - 1受体激动剂,全球尚无同类口服药上市。截至目前,相关项目累计研发投入约3.69亿元。药 品研发到上市周期长、环节多,存在不确定性,公司将推进项目并披露进展。 ...
恒瑞医药:注射用SHR-1826纳入突破性治疗品种名单
Xin Lang Cai Jing· 2026-01-12 09:06
Group 1 - The core point of the article is that Heng Rui Medicine's injectable SHR-1826 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] Group 2 - The announcement was made by Heng Rui Medicine, specifically through its subsidiary Suzhou Sediya Biopharmaceutical Co., Ltd [1]
恒瑞医药:注射用SHR-1826被纳入突破性治疗品种名单
Mei Ri Jing Ji Xin Wen· 2026-01-12 09:06
Core Viewpoint - Heng Rui Medicine's 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 (NMPA) [1] Company Summary - Heng Rui Medicine (600276.SH) announced the inclusion of its injectable SHR-1826 in the breakthrough therapy list by the NMPA [1]
化学制药板块1月12日涨0.15%,向日葵领涨,主力资金净流出16.64亿元
| 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 300111 | 向日葵 | 7.29 | 11.98% | 167.84万 | | 11.97亿 | | 000766 | 通化金马 | 27.87 | 9.98% | 46.86万 | | 12.97亿 | | 002940 | 昂利康 | 38.66 | 7.87% | 25.79万 | | 9.79亿 | | 300401 | 化园生物 | 17.36 | 5.60% | - 54.32万 | | 2666 | | 920367 | 新赣江 | 23.50 | 5.48% | 5.45万 | | 1.26亿 | | 688176 | 亚虹医药 | 12.60 | 5.09% | 19.90万 | | 2.45亿 | | 301281 | 科源制药 | 30.83 | 5.08% | 4.03万 | | 1.22亿 | | 000908 | *ST景峰 | 8.19 | 5.00% | 3.17万 | | 2599.61万 | ...