Hengrui Pharma(600276)
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恒瑞医药:注射用瑞康曲妥珠单抗临床试验获批准
Zhi Tong Cai Jing· 2025-11-25 10:43
恒瑞医药(600276)(600276.SH)公告,公司子公司苏州盛迪亚生物医药有限公司收到国家药品监督管 理局核准签发关于注射用瑞康曲妥珠单抗的《药物临床试验批准通知书》,同意单药在HER2扩增实体 瘤患者中开展临床试验。 ...
11月25日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-25 10:16
分组1 - Weili Medical plans to distribute a cash dividend of 2 yuan per 10 shares to all shareholders, based on an undistributed profit of 704 million yuan as of September 30, 2025 [1] - Tongding Interconnect's shareholder plans to reduce their stake by up to 0.49%, equating to a maximum of 605,800 shares [1] - Caitong Securities has received approval from the China Securities Regulatory Commission to issue short-term corporate bonds with a total face value of up to 5 billion yuan [1] 分组2 - Youfu Food intends to use 70 million yuan of its own funds to invest in wealth management products with expected annual returns of up to 4.2% [3] - Keres received an administrative regulatory decision from the Guangdong Securities Regulatory Bureau for violations related to accounts receivable aging calculations and related party transactions [5] - Ouma Software's controlling shareholder has completed the transfer of state-owned equity, changing the controlling shareholder to Shandong Guotou [7] 分组3 - ST Huapeng's wholly-owned subsidiary has completed a major overhaul project and is now in production [8] - Beiqi Blue Valley has received approval from the China Securities Regulatory Commission for a stock issuance to specific investors [8] - Weijie Chuangxin received a government subsidy of 5 million yuan, accounting for 21.07% of its projected net profit for 2024 [9] 分组4 - China Resources Double Crane's subsidiary has received a drug registration certificate for a hypertension treatment drug [11] - Huafeng shares are continuing to suspend trading due to a planned change in control [13] - Kaifa Electric's shareholder plans to transfer 36.6869 million shares, representing 11.63% of the total share capital [14] 分组5 - Heng Rui Medicine has received approval for two clinical trials for innovative anti-tumor drugs [15] - Kosen Technology plans to invest 30 million USD to establish a new production base in Malaysia [17] - Sanxing Medical's subsidiary is expected to win a procurement project from the State Grid worth approximately 107 million yuan [18] 分组6 - Sitai Li's subsidiary has received a drug registration certificate for a contrast agent used in MRI [21] - Daren Tang's subsidiary has received a drug registration certificate for a pain relief gel [22] - Saike Xide has received approval for three medical device products, expanding its product range in the in vitro diagnostic field [23] 分组7 - Hasa Lian has elected a new chairman and vice chairman for its board of directors [24] - Two-sided Needle's subsidiary plans to invest 68.8522 million yuan in a production base expansion project [25] - Sunshine Nuohe plans to transfer 70% of its controlling subsidiary's equity for 2 million yuan [26] 分组8 - Hengbang shares received an administrative regulatory decision from the Shandong Securities Regulatory Bureau for failing to complete the election of independent directors [27] - Huali shares plan to sign a related transaction contract worth approximately 59.2847 million yuan [28] - Shangwei shares plan to invest 520.4 million yuan to gain a controlling stake in Sichuan Zhongfu Taihua [30] 分组9 - Zejing Pharmaceutical's ZG006 has been included in the list of breakthrough therapeutic varieties for treating advanced neuroendocrine cancer [32] - Yaopi Glass's shareholder plans to reduce their stake by up to 2.26%, equating to a maximum of 21.1469 million shares [34] - Huate Gas has initiated a major lawsuit involving a claim of 180 million yuan [36] 分组10 - Zhongchumei's controlling shareholder plans to increase their stake by between 42 million and 80 million yuan [37] - Huitong shares' shareholder plans to reduce their stake by up to 1% [38] - Miaowei Exhibition plans to apply for an initial public offering of H shares on the Hong Kong Stock Exchange [40] 分组11 - Tianqi Lithium's subsidiary has appealed to the Chilean Supreme Court regarding a partnership agreement with SQM and Codelco [42] - Naxin Micro plans to repurchase shares worth between 200 million and 400 million yuan [44] - Pingao shares have reported significant uncertainty regarding future business development and profitability [46] 分组12 - Shunyu shares have been pre-selected for a project worth 1.023 billion yuan [48] - Zhongyuan Neipei plans to acquire a 2.5% share in an aerospace industry fund for 50 million yuan [50] - Huifa Food's shareholder plans to reduce their stake by up to 3%, equating to a maximum of 727.14 million shares [53] 分组13 - Junshi Biosciences' subcutaneous PD-1 new formulation has reached its primary endpoint in a Phase III clinical trial [54] - Industrial Fulian clarified that it has not lowered its fourth-quarter profit target amid market rumors [55] - Longpan Technology's subsidiary has signed a major supply agreement for lithium iron phosphate materials, significantly increasing the supply volume [56]
恒瑞医药:子公司收到关于注射用瑞康曲妥珠单抗的《药物临床试验批准通知书》
Zheng Quan Ri Bao· 2025-11-25 09:38
(文章来源:证券日报) 证券日报网讯 11月25日晚间,恒瑞医药发布公告称,近日,公司子公司苏州盛迪亚生物医药有限公司 收到国家药品监督管理局核准签发关于注射用瑞康曲妥珠单抗的《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:公司收到关于HRS-8364片的《药物临床试验批准通知书》
Zheng Quan Ri Bao· 2025-11-25 09:38
(文章来源:证券日报) 证券日报网讯 11月25日晚间,恒瑞医药发布公告称,近日,公司收到国家药品监督管理局核准签发关 于HRS-8364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:获得注射用瑞康曲妥珠单抗临床试验批准通知书
Ge Long Hui· 2025-11-25 09:25
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection Rituximab, indicating a significant step in the development of this new drug [1] Company Summary - The drug, injection Rituximab, targets HER2-expressing tumor cells, inducing apoptosis through a mechanism that involves the release of a highly permeable toxin [1] - The total research and development investment for injection Rituximab has reached approximately 141.4 million yuan [1] Industry Summary - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have also been approved for sale in China [1] - The global sales of similar products are projected to reach approximately 6.557 billion USD by 2024 [1] - The approval process for drugs in China requires clinical trials to be conducted and reviewed by the National Medical Products Administration before they can be marketed [2]
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
2025-11-25 09:15
受 理 号:CXSL2500754 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9月1日受理的注射用瑞康曲妥珠单抗临床试验申请符合药品注册的有关要求, 同意本品单药在 HER2 扩增实体瘤患者中开展临床试验。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-188 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")子公司苏州盛迪亚 生物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 发关于注射用瑞康曲妥珠单抗的《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: 一、药品的基本情况 药品名称:注射用瑞康曲妥珠单抗 剂 型:注射剂 申请事项:临床试验 二、药品的已获批适应症情况 公司注射用瑞康曲妥珠单抗已于 2025 年 5 月在国内获批上市,适用于治疗 存在 HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除 ...
资讯日报:中美元首进行上月会晤以来的首次通话-20251125
Guoxin Securities Hongkong· 2025-11-25 09:13
Market Overview - The Hong Kong stock market showed a significant recovery on November 24, with all three major indices ending a streak of declines[9] - Large tech stocks performed strongly, with Kuaishou rising over 7%, and NetEase and Bilibili increasing over 5%[9] - The Hang Seng Tech Index closed at 5,546, up 2.78% for the day and 24.11% year-to-date[3] Sector Performance - Innovative pharmaceuticals and outsourcing concepts saw notable gains, with companies like Innovent Biologics rising over 6%[9] - Military stocks also performed well, with China Shipbuilding Defense up over 13%[9] - Oil stocks were weak, with China National Offshore Oil Corporation and China Oilfield Services both declining over 1%[9] U.S. Market Insights - On the same day, U.S. markets saw all three major indices close higher, driven by increased bets on a Federal Reserve rate cut[9] - The "Magnificent Seven" tech stocks, including Google and Nvidia, all rose, with Google gaining over 6%[9] - The S&P 500 index is projected to achieve double-digit annual growth according to HSBC strategists[14] Economic Indicators - The Federal Reserve is expected to cut rates in December, with market predictions showing a 70% probability[14] - The U.S. economy's third-quarter GDP report has been delayed due to a government shutdown, affecting economic analysis[14] Investment Trends - The Nasdaq Golden Dragon China Index rose by 2.82%, indicating a positive trend for Chinese concept stocks[13] - Significant inflows into semiconductor stocks were noted, with companies like Broadcom surging 11%[13]
恒瑞医药(600276.SH):注射用瑞康曲妥珠单抗临床试验获批准
智通财经网· 2025-11-25 09:09
Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection drug Rukang Qutuzumab in patients with HER2-positive solid tumors [1] Group 1 - The approval allows for the clinical trial of Rukang Qutuzumab as a monotherapy [1] - The focus of the trial is on patients with HER2 amplification in solid tumors [1]
恒瑞医药(600276.SH):获得注射用瑞康曲妥珠单抗临床试验批准通知书
Ge Long Hui A P P· 2025-11-25 09:09
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection Rituximab, indicating a significant step in the development of this new drug [1] Company Summary - The drug, injection Rituximab, targets HER2-expressing tumor cells, inducing apoptosis through a mechanism that involves the release of a highly permeable toxin [1] - The total research and development investment for injection Rituximab has reached approximately 141.4 million yuan [1] Industry Summary - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which are available domestically [1] - The global sales of similar products are projected to reach approximately 6.557 billion USD by 2024 [1] - Other competitors in the domestic market include Rongchang Biopharmaceutical's Vidi-situzumab, approved in 2021, and Kelun-Botai's Bodu-trastuzumab, expected to be approved in 2025 [1]
恒瑞医药(600276.SH):获得HRS-8364片的临床试验批准通知书
Ge Long Hui A P P· 2025-11-25 09:09
HRS-8364 片是公司自主研发的创新型抗肿瘤药物,拟用于治疗晚期实体瘤。经查询,目前国内外尚无 同类药物获批上市。截至目前,HRS-8364 片相关项目累计研发投入约2165万元。 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。 格隆汇11月25日丨恒瑞医药(600276.SH)公布,近日,公司收到国家药监局核准签发关于HRS-8364片的 《药物临床试验批准通知书》,将于近期开展临床试验。药物名称:HRS-8364 片,受理号: CXHL2500944、CXHL2500945。 ...