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恒瑞医药:子公司获批HRS-7535片Ⅲ期临床试验开展资格
Xin Lang Cai Jing· 2026-01-29 12:46
Group 1 - Approval Status: Subsidiary Shandong Shengdi Pharmaceutical received the "Drug Clinical Trial Approval Notice" for HRS-7535, approved to conduct Phase III clinical trials for the treatment of chronic kidney disease [1][2] - Drug Characteristics: A novel oral small molecule GLP-1R agonist, with no similar oral drugs available globally. Mechanism of action includes promoting insulin secretion, lowering glucagon levels, inhibiting gastric emptying, and enhancing satiety. Preclinical data shows significant improvement in chronic kidney disease symptoms in animals [1][2] - R&D Investment: Cumulative R&D investment to date is approximately 369 million yuan (unaudited) [1][2]
1月29日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-29 10:13
Earnings Forecasts - Shengyi Electronics expects a net profit of 1.431 billion to 1.513 billion yuan in 2025, an increase of 331.03% to 355.88% year-on-year [1] - Tigermed anticipates a net profit of 830 million to 1.23 billion yuan in 2025, representing a growth of 105% to 204% year-on-year [2] - Shunbo Alloy forecasts a net profit of 210 million to 270 million yuan in 2025, with an increase of 222.96% to 315.23% year-on-year [3] - Jinkong Electric expects a net profit of 155 million to 195 million yuan in 2025, reflecting a growth of 383.21% to 507.9% year-on-year [9] - Baiao Saitu anticipates a net profit of 162 million to 182 million yuan in 2025, with a year-on-year increase of 384.26% to 443.88% [18] - Panjiang Co. expects a net profit of 318 million to 380 million yuan in 2025, representing a growth of 205.30% to 264.83% year-on-year [38] Loss Forecasts - Liaoning Energy predicts a net loss of 273 million to 410 million yuan in 2025, compared to a profit of 202 million yuan in the previous year [5] - Anbotong anticipates a net loss of 114 million to 165 million yuan in 2025, with a revenue decrease of 19.65% to 27.25% [7] - Wantai Bio forecasts a net loss of 330 million to 410 million yuan in 2025, compared to a profit of 106 million yuan in the previous year [12] - Xingyun Co. expects a net loss of 155 million to 230 million yuan in 2025, compared to a loss of 82.44 million yuan in the previous year [20] - Huaxing Co. anticipates a net loss of 800 million to 1.2 billion yuan in 2025, with a reduction in loss compared to 1.67 billion yuan in the previous year [46] New Product Approvals - Hengrui Medicine received acceptance for a new indication application for its innovative drug, combining Carrelizumab and Apatinib for treating unresectable liver cancer [4] - Tianen Kang's subsidiary received a drug registration acceptance notice for Lidocaine and Prilocaine aerosol [31] - Lisheng Pharmaceutical announced that its Aminophylline tablets passed the consistency evaluation for generic drugs [40] Share Buyback Plans - Hengyuan Coal Power plans to repurchase shares with a total amount not less than 200 million yuan and not exceeding 250 million yuan [13] Contract Wins - China Communication Signal Co. won contracts totaling approximately 5.26 billion yuan for 21 important projects in the railway and urban rail transit markets [37]
恒瑞医药获得HRS-7535片临床试验批准通知书
Zhi Tong Cai Jing· 2026-01-29 09:40
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-7535, a novel oral small molecule GLP-1 receptor agonist, which shows promise in treating chronic kidney disease and obesity-related conditions [1] Group 1: Product Development - HRS-7535 is designed to activate GLP-1 receptors, promoting insulin secretion and reducing glucagon secretion while also suppressing gastric emptying [1] - The drug has shown significant improvement in preclinical models of chronic kidney disease (CKD) [1] - The total research and development investment for HRS-7535 has reached approximately 36.94 million yuan (unaudited) [1] Group 2: Market Context - There are currently no oral small molecule GLP-1 receptor agonists available in the global market [1]
恒瑞医药(01276)获得HRS-7535片临床试验批准通知书
智通财经网· 2026-01-29 09:29
Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for HRS-7535 tablets, a novel oral small molecule GLP-1 receptor agonist [1] Group 1: Product Development - HRS-7535 tablets are designed to activate human GLP-1 receptors, promoting insulin secretion from the pancreas, reducing glucagon secretion, and inhibiting gastric emptying [1] - The drug also enhances satiety and suppresses appetite through central nervous system effects, leading to a direct reduction in energy intake [1] - Preclinical data indicates that HRS-7535 can significantly improve symptoms of chronic kidney disease (CKD) in animal models [1] Group 2: Market Context - There are currently no oral small molecule GLP-1 receptor agonists available in the global market [1] - The total research and development investment for the HRS-7535 project has reached approximately 369.4 million yuan (unaudited) [1]
恒瑞医药(01276.HK):子公司“HRS-7535 片”获药物临床试验批准
Ge Long Hui· 2026-01-29 09:28
Core Viewpoint - Heng Rui Medicine's subsidiary, Shandong Shengdi Pharmaceutical, has received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will be used to treat chronic kidney disease [1]. Group 1: Drug Information - Drug Name: HRS-7535 tablets [1] - Dosage Form: Tablet [1] - Application Matter: Clinical trial [1] - Acceptance Numbers: CXHL2501214, CXHL2501215, CXHL2501216 [1] Group 2: Approval Details - Approval Conclusion: HRS-7535 tablets meet the requirements for drug registration and are allowed to proceed with Phase III clinical trials [1] - Application Indication: Intended for the treatment of chronic kidney disease [1] - Acceptance Date: November 5, 2025 [1]
恒瑞医药(01276)创新药注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片新适应症的上市许可申请获受理
Zhi Tong Cai Jing· 2026-01-29 09:28
Core Viewpoint - Heng Rui Medicine (01276) has received a notice from the National Medical Products Administration regarding the acceptance of its application for the marketing license of the innovative drug injection of Camrelizumab combined with Apatinib for a new indication [1] Group 1: Clinical Trial Details - The application for the new indication is based on a randomized, controlled, open-label, multicenter Phase III clinical trial (SHR-1210-III-336 study) evaluating the efficacy and safety of Camrelizumab and Apatinib combined with TACE compared to TACE alone in patients with unresectable hepatocellular carcinoma [1] - The study was led by Academician Fan Jia and Professor Qin Shukui from Zhongshan Hospital, Fudan University, with participation from 34 centers nationwide, enrolling a total of 423 patients [1] Group 2: Study Outcomes - The primary efficacy endpoint was progression-free survival (PFS) assessed by a blinded independent radiological review committee (BIRC); secondary endpoints included overall survival (OS), investigator-assessed PFS, BIRC and investigator-assessed objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) [1] - Interim analysis results indicated that the PFS assessed by BIRC showed a significant clinical improvement in the Camrelizumab combined with Apatinib and TACE group compared to the TACE alone treatment, with a trend observed for OS benefit [1] - This combination therapy is expected to become a new clinical treatment option for patients with unresectable hepatocellular carcinoma [1]
恒瑞医药(01276.HK):创新药注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片新适应症的上市许可申请获受理
Ge Long Hui· 2026-01-29 09:20
Core Viewpoint - Heng Rui Medicine (01276.HK) has received a notice from the National Medical Products Administration regarding the acceptance of its new indication application for the innovative drug injection of Carrelizumab combined with Apatinib Mesylate tablets [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., have successfully submitted a listing application for a new indication [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
2026-01-29 09:18
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) 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。 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 2026年1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。 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 ...
恒瑞医药(01276) - 海外监管公告 - 关於药品上市许可申请获受理的提示性公告
2026-01-29 09:15
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) 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。 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 2026年1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。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-01 ...
化学制药板块1月29日跌0.01%,亚虹医药领跌,主力资金净流出7.28亿元
| 代码 | 名称 | 主力净流入(元) | 主力净占比 游资净流入(元) | | 游资净占比 散户净流入(元) | | 散户净占比 | | --- | --- | --- | --- | --- | --- | --- | --- | | 600276 恒瑞医药 | | 3.33 Z | 5.10% | -2.89 Z | -4.43% | -4421.19万 | -0.68% | | 000963 华东医药 | | 1.15 Z | 16.50% | -7275.41万 | -10.40% | -4271.00万 | -6.10% | | 000813 德展健康 | | 1.02亿 | 50.51% | -6009.16万 | -29.70% | -4212.39万 | -20.82% | | 300436 | 广生堂 | 1.01亿 | 5.29% | -2204.37万 | -1.16% | -7860.17万 | -4.13% | | 688382 益方生物 | | 3813.99万 | 13.10% | -337.73万 | -1.16% | -3476.26万 | -11.94% | | 600 ...