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恒瑞医药(01276): HRS-6208 胶囊、HRS-6209 胶囊、HRS-8080 片、HRS-1358 片、HRS-5041 片获批开展临床试验
智通财经网· 2025-12-19 12:08
Core Viewpoint - The company, Heng Rui Medicine, has received approval from the National Medical Products Administration for clinical trials of five new drug candidates, indicating a significant advancement in its oncology pipeline [1][2][3]. Group 1: Drug Candidates Overview - HRS-6208 is a novel, highly selective small molecule inhibitor that effectively suppresses phosphorylation activation of its target, impacting cell cycle and transcriptional activity to inhibit tumor cell proliferation. No similar products have been approved in the market, with a cumulative R&D investment of approximately 38.14 million yuan [1]. - HRS-6209 is a selective CDK4 inhibitor that induces tumor cell arrest in the G1 phase, aimed at treating advanced malignant solid tumors. It shows improved selectivity over CDK6/cyclinD3 pathways compared to existing CDK4/6 inhibitors, with a cumulative R&D investment of about 119.85 million yuan [2]. - HRS-8080 is a novel oral selective estrogen receptor degrader (SERD) designed to degrade ER and inhibit its activity, targeting ER-positive and ER-mutated breast cancer. The cumulative R&D investment for this project is around 198.70 million yuan [2]. - HRS-5041 is a new, highly selective AR PROTAC molecule intended for prostate cancer treatment, demonstrating significant degradation of wild-type and most mutant AR proteins, with a cumulative R&D investment of approximately 92.66 million yuan [3]. - HRS-1358 is a targeted estrogen receptor (ER) degrading PROTAC molecule that can overcome resistance due to target protein mutations, with a cumulative R&D investment of about 96.01 million yuan [3].
恒瑞医药(01276.HK):注射用醋酸亮丙瑞林微球获药物临床试验批准
Ge Long Hui· 2025-12-19 12:07
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its injectable Leuprolide Acetate Microspheres, targeting prostate cancer treatment [1] Drug Information - Drug Name: Injectable Leuprolide Acetate Microspheres [1] - Dosage Form: Injectable [1] - Application Matter: Clinical Trial [1] - Acceptance Number: CYHL2500159 [1] - Approval Conclusion: The clinical trial application for Injectable Leuprolide Acetate Microspheres, accepted on August 29, 2025, meets the requirements for drug registration and is approved to conduct clinical trials for prostate cancer [1]
恒瑞医药:注射用醋酸亮丙瑞林微球获批开展临床试验
Zhi Tong Cai Jing· 2025-12-19 12:04
据悉,醋酸亮丙瑞林是 GnRH 类似物,用于治疗前列腺癌。塬研产品 LEUPLIN Pro 由武田药品工业株 式会社开发,2015 年 11 月获日本 PMDA 批准上市,尚未在国内上市。本品用法用量与中国已上市的 注射用亮丙瑞林微球不同,属仿制境外已上市但境内未上市的原研药品。截至目前,注射用醋酸亮丙瑞 林微球相关项目累计研发投入约 2,468 万元。 恒瑞医药(600276)(01276)公布,近日,公司子公司上海恒瑞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醋酸亮丙瑞林微球的《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(01276):注射用醋酸亮丙瑞林微球获批开展临床试验
智通财经网· 2025-12-19 12:01
Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of injectable acetic acid leuprolide microspheres, which will be conducted shortly [1] Group 1: Product Information - Acetic acid leuprolide is a GnRH analog used for the treatment of prostate cancer [1] - The original research product LEUPLIN®Pro was developed by Takeda Pharmaceutical Company and was approved for market in Japan in November 2015, but has not yet been launched domestically [1] - The dosage and administration of the injectable acetic acid leuprolide microspheres differ from the already marketed injectable leuprolide microspheres in China, making it a generic version of an overseas product that has not been launched domestically [1] Group 2: Financial Investment - The total research and development investment for the injectable acetic acid leuprolide microspheres project has reached approximately 24.68 million yuan [1]
恒瑞医药注射用醋酸亮丙瑞林微球临床试验获批
Bei Jing Shang Bao· 2025-12-19 11:57
公告显示,醋酸亮丙瑞林是GnRH类似物,用于治疗前列腺癌。原研产品LEUPLIN Pro由武田药品工业 株式会社开发,2015年11月获日本PMDA批准上市,尚未在国内上市。本品用法用量与中国已上市的注 射用亮丙瑞林微球不同,属仿制境外已上市但境内未上市的原研药品。 北京商报讯(记者王寅浩宋雨盈)12月19日,恒瑞医药(600276)发布公告称,公司子公司上海恒瑞医药 有限公司收到国家药品监督管理局核准签发关于注射用醋酸亮丙瑞林微球的《药物临床试验批准通知 书》,同意该品开展前列腺癌的临床试验。 ...
恒瑞医药SHR-2906注射液临床试验获批
Bei Jing Shang Bao· 2025-12-19 11:46
Core Viewpoint - Heng Rui Medicine's subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-2906 injection, aimed at treating overweight or obesity [1] Group 1: Product Development - SHR-2906 injection is a self-developed biological product by Heng Rui Medicine, expected to have a synergistic effect in reducing energy intake and promoting energy expenditure, thereby regulating glucose and lipid metabolism and controlling weight [1] - The product aims to improve the metabolic environment within the body, potentially demonstrating clinical efficacy in treating overweight and obesity [1]
恒瑞医药(600276.SH):获得SHR-2906注射液临床试验批准通知书
Ge Long Hui· 2025-12-19 10:25
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of SHR-2906 injection, a self-developed therapeutic biological product aimed at regulating glucose and lipid metabolism and controlling weight [1] Group 1: Product Development - SHR-2906 injection is expected to synergistically reduce energy intake and promote energy expenditure, improving the metabolic environment in the body and potentially offering clinical efficacy in treating overweight and obesity [1] - There are currently no similar drugs approved for market use domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-2906 injection project has reached approximately 17.06 million yuan [1]
恒瑞医药(600276.SH):获得关于SHR-9539注射液、HRS-3738片的临床试验批准通知书
Ge Long Hui· 2025-12-19 10:25
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of SHR-9539 injection and HRS-3738 tablets, marking a significant step in its drug development pipeline [1] Group 1: SHR-9539 Injection - SHR-9539 injection is a Class 1 therapeutic biological product that targets and kills multiple myeloma cells by activating T cells [1] - Currently, there are no similar drugs approved for market in China [1] - The cumulative R&D investment for the SHR-9539 injection project is approximately 39.93 million yuan [1] Group 2: HRS-3738 Tablets - HRS-3738 tablets are a next-generation CRBN E3 ubiquitin ligase modulator that affects the proliferation of hematological tumor cells by degrading specific substrates [1] - The drug has potential advantages in substrate degradation capability and overcoming drug resistance [1] - There are no similar drugs approved for market domestically or internationally [1] - The cumulative R&D investment for the HRS-3738 tablet project is approximately 63.63 million yuan [1]
12月19日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-19 10:19
Group 1 - Sichuan Chengyu's wholly-owned subsidiary plans to acquire 85% equity of Hubei Jingyi Company for 2.409 billion yuan, enhancing the company's control over highway projects [1] - Huadian Technology signed contracts worth approximately 815 million yuan with Huadian Technology Group for a wind power hydrogen production project [2] - Dongfang Cable and its subsidiary won projects totaling approximately 3.125 billion yuan, accounting for 34.37% of the company's audited revenue for 2024 [3] Group 2 - Heng Rui Medicine received approval for clinical trials of SHR-2906 injection, a self-developed biopharmaceutical aimed at weight control and metabolic regulation [4] - Qingdao Port plans to invest approximately 15.7 billion yuan in two terminal projects [5] - Jingu Co. received a notification to supply low-carbon wheels for two export models to a major domestic car manufacturer, with production expected in 2026 [6] Group 3 - ST Xingguang won a procurement project worth approximately 22.955 million yuan, accounting for 11.96% of the company's revenue for 2024 [7] - Xinbo Co. plans to jointly invest in an alloy materials research institute with partners, focusing on high-performance materials for various industries [8] - Tianqi Lithium's third-phase lithium concentrate expansion project has been completed and is undergoing trial production, with a total capacity of 2.14 million tons per year [9] Group 4 - Changfei Fiber reported that new fiber optic products related to data centers represent a small proportion of total demand [10] - Dongfang Bio's subsidiaries obtained multiple medical device registration certificates, including various testing kits [11] - Xiugang Co. plans to use up to 500 million yuan of idle fundraising for cash management in safe, liquid investment products [12] Group 5 - Jifeng Co. received a project designation for passenger car seat assemblies from a European luxury brand, with a total lifecycle value of approximately 9.8 billion yuan [13] - CanSino initiated Phase I clinical trials for a combined vaccine, completing the first subject enrollment [14] - Dayu Water-saving's subsidiary pre-won a drainage project worth 140 million yuan and another project worth 1 billion yuan [15] Group 6 - Yutong Pharmaceutical's subsidiary received clinical trial approval for YKYY032 injection for treating hyperlipoproteinemia [17] - Diweier announced the departure of a core technical personnel, impacting its technical leadership [18] - Weilang Co.'s controlling shareholder received regulatory measures from the Shandong Securities Regulatory Bureau for failing to fulfill a commitment [19] Group 7 - Xiehe Electronics invested 5 million yuan in a private equity fund focusing on hard technology sectors [20] - Phoenix Optical received a government subsidy of 4.7053 million yuan, representing 35% of its projected net profit for 2024 [21] - China State Construction reported a 0.9% year-on-year increase in new contracts signed in the first 11 months of 2025, totaling 4.0408 trillion yuan [22] Group 8 - Nanguang Energy's pumped storage power station units 1 and 2 have entered trial operation, with units 3 and 4 expected to follow by year-end [23] - Jindalai plans to invest 280 million yuan to acquire a 34% stake in Yunnan Jici Medical Technology [24] - Geer Software terminated its planned acquisition of a majority stake in Weipin Zhiyuan due to failure to reach agreement on key terms [25] Group 9 - Ningbo Fubang completed the absorption merger of its wholly-owned subsidiary, inheriting all assets and liabilities [26] - Zhongyuan Neipei signed a strategic cooperation framework agreement with Ningbo Puzhi Company for humanoid robot-related business [28] - Gongyuan Co. announced a business integration and relocation of its production lines in the East China region [29] Group 10 - Chlor-alkali Chemical's subsidiary plans to invest 2.975 billion yuan in a comprehensive utilization project for waste salt [30] - Kain Technology announced the departure of a core technical personnel, impacting its research capabilities [31] - ST Renfu received approval for clinical trials of a new drug for idiopathic pulmonary fibrosis [32] Group 11 - Sanbo Brain Science's established brain science fund has completed registration with the Asset Management Association of China [33] - Tongyou Technology plans to apply for a 70 million yuan credit line from Beijing Bank, using its property as collateral [34] - Bai Ao Intelligent signed a significant equipment sales contract worth approximately 27.5021 million yuan [35] Group 12 - ST Xinyan received all restructuring investment funds totaling 2.239 billion yuan, entering the execution phase of its restructuring plan [36] - Dalu Real Estate's subsidiary decided to terminate a planned acquisition of a 60% stake in Beijing Chengzhu Real Estate [38] - Huiyu Pharmaceutical's products received marketing approval in Italy and Norway [39]
恒瑞医药(600276.SH):获得关于注射用醋酸亮丙瑞林微球的临床试验批准通知书
Ge Long Hui A P P· 2025-12-19 09:40
醋酸亮丙瑞林是GnRH类似物,用于治疗前列腺癌。原研产品LEUPLIN®Pro由武田药品工业株式会社开 发,2015年11月获日本PMDA批准上市,尚未在国内上市。本品用法用量与中国已上市的注射用亮丙瑞林 微球不同,属仿制境外已上市但境内未上市的原研药品。截至目前,注射用醋酸亮丙瑞林微球相关项目累 计研发投入约2468万元。 格隆汇12月19日丨恒瑞医药(600276.SH)公布,近日,公司子公司上海恒瑞医药有限公司收到国家药监局核 准签发关于注射用醋酸亮丙瑞林微球的《药物临床试验批准通知书》,将于近期开展临床试验。 ...