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江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理 的提示性公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-01-09 23:14
Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. has received acceptance for the drug listing application of HRS-5965 capsules from the National Medical Products Administration (NMPA) [1] - The drug HRS-5965 is intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1][2] - The clinical trial for HRS-5965 demonstrated significant improvements in hemoglobin levels, reduced need for blood transfusions, and enhanced quality of life compared to the existing treatment, eculizumab [2] Group 2 - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [3] - HRS-5965 is a complement factor B inhibitor that aims to improve hemoglobin levels in PNH patients [3] - Currently, the only approved drug for this indication is Novartis's eculizumab, which is projected to have global sales of approximately $129 million in 2024 [3] Group 3 - The company has also received clinical trial approval for several other drugs, including SHR-4394 for prostate cancer, HRS-5041 for prostate cancer, and Zemeituzumab for peripheral T-cell lymphoma [9][10][11] - SHR-4394 has a cumulative R&D investment of approximately 38.4 million yuan, while HRS-5041 has an investment of about 92.66 million yuan [9][10] - Zemeituzumab was approved in 2025 and has a cumulative R&D investment of around 216.82 million yuan, with a projected global sales of approximately $51 million in 2024 [10]
恒瑞医药:注射用SHR-4394、HRS-5041片、泽美妥司他片(SHR 2554)、瑞维鲁胺片获签发《药物临床试验批准通知书》
Zhi Tong Cai Jing· 2026-01-09 10:57
Core Insights - 恒瑞医药 has received approval from the National Medical Products Administration for clinical trials of several new drugs, including SHR-4394, HRS-5041, Zemeituzumab, and Rivolumab [1][2] Group 1: Drug Approvals and Clinical Trials - The company has been granted approval to conduct clinical trials for SHR-4394, a self-developed biopharmaceutical aimed at treating prostate cancer, with a total R&D investment of approximately 38.4 million yuan [1] - HRS-5041 is a new, efficient, and selective AR PROTAC small molecule also targeting prostate cancer, with a total R&D investment of about 92.66 million yuan [1] - Zemeituzumab is a novel oral EZH2 inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in adults, with a total R&D investment of around 217 million yuan [2] - Rivolumab is a second-generation AR inhibitor approved for treating high-burden metastatic hormone-sensitive prostate cancer, with a total R&D investment of approximately 697 million yuan [2] Group 2: Market Context and Competitors - Currently, there are no approved products in the market for SHR-4394 and HRS-5041, indicating a potential first-mover advantage for the company [1] - Zemeituzumab faces competition from Tazemetostat and Valemetostat, which are already approved in the market, with Tazemetostat projected to generate global sales of about 51 million dollars in 2024 [2] - Rivolumab competes with several second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, with projected global sales of similar products reaching approximately 11.037 billion dollars in 2024 [2]
恒瑞医药(01276):注射用SHR-4394、HRS-5041片、泽美妥司他片(SHR 2554)、瑞维鲁胺片获签发《药物临床试验批准通知书》
智通财经网· 2026-01-09 10:53
Core Insights - The company has received approval from the National Medical Products Administration for clinical trials of several new drugs, including SHR-4394, HRS-5041 tablets, Zemeituzumab tablets, and Rivolumab tablets [1][2] Group 1: SHR-4394 - SHR-4394 is a self-developed biopharmaceutical intended for the treatment of prostate cancer, with no similar products approved for sale domestically or internationally [1] - The total R&D investment for SHR-4394 has reached approximately 38.4 million yuan [1] Group 2: HRS-5041 Tablets - HRS-5041 is a new, efficient, and selective AR PROTAC small molecule aimed at treating prostate cancer, showing significant degradation effects on wild-type and most mutant AR proteins [1] - There are currently no similar products approved for sale domestically or internationally, with a total R&D investment of about 92.66 million yuan [1] Group 3: Zemeituzumab Tablets - Zemeituzumab is a new, efficient, and selective oral EZH2 inhibitor approved for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have received at least one line of systemic therapy [2] - Similar products include Tazemetostat and Valemetostat, with Tazverik's global sales projected to be approximately 51 million dollars in 2024 [2] - The total R&D investment for Zemeituzumab has reached about 217 million yuan [2] Group 4: Rivolumab Tablets - Rivolumab is a second-generation AR inhibitor with stronger AR inhibition and no agonistic effects, approved for the treatment of high-burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [2] - Competing products include Enzalutamide, Apalutamide, and Darolutamide, with global sales of similar products projected to be around 11.037 billion dollars in 2024 [2] - The total R&D investment for Rivolumab has reached approximately 697 million yuan [2]
恒瑞医药(01276.HK):注射用SHR-4394、HRS-5041片、泽美妥司他片(SHR-2554)、瑞维鲁胺片获药物临床试验批准
Ge Long Hui· 2026-01-09 10:52
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of multiple drugs, indicating progress in its oncology treatment pipeline [1] Group 1: Drug Approvals - Jiangsu Heng Rui Medicine Co., Ltd. and its subsidiaries have been granted clinical trial approval for SHR-4394, HRS-5041 tablets, Zemeituo Sita tablets (SHR-2554), and Ruvelamine tablets [1] - The approval is based on compliance with the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] Group 2: Clinical Trials - The clinical trials will focus on the safety, tolerability, and efficacy of SHR-4394 or HRS-5041 in combination with anti-tumor treatment in participants with prostate cancer [1] - The trials are categorized as multi-center and open-label Phase II studies [1]
恒瑞医药四款药物临床试验获批
Bei Jing Shang Bao· 2026-01-09 10:29
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of multiple drugs, indicating progress in its oncology pipeline [1] Group 1: Clinical Trials - The company and its subsidiaries, Chengdu Shengdi Pharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have been granted clinical trial approval for SHR-4394, HRS-5041 tablets, Zemeituosita tablets (SHR-2554), and Rivirolem tablets [1] - The specific focus of the clinical trials will be on the safety, tolerability, and efficacy of SHR-4394 or HRS-5041 in combination with anti-tumor treatment in participants with prostate cancer [1]
1月9日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-09 10:19
Group 1 - China Shipbuilding Defense expects a net profit of 940 million to 1.12 billion yuan for 2025, an increase of 149.61% to 196.88% year-on-year [1] - China First Heavy Industries has only undertaken a small number of related accessory projects and has not generated revenue from them [2] - Huanyu Electronics plans to invest 30 million yuan in a private equity fund focused on AI and emerging industries [3] Group 2 - Zhixiang Jintai's GR1803 injection has been included in the priority review list by the National Medical Products Administration [4] - JianKai Technology's shareholder plans to reduce holdings by up to 3% of the company's shares [5] - Debon Holdings will continue to suspend trading from January 12 due to significant matters being planned [6] Group 3 - South Network Technology's shareholder intends to transfer 847.05 million shares, accounting for 1.50% of the total share capital [7] - Hengrui Medicine has received approval for clinical trials of four drugs [8] - Daotong Technology expects a net profit of 900 million to 930 million yuan for 2025, a year-on-year increase of 40.42% to 45.10% [10] Group 4 - Betta Pharmaceuticals has invested 50 million yuan to acquire a 20% stake in Hangzhou Zhixing Pharmaceutical [11] - Tianyu Biology reported a 10.38% year-on-year decline in cumulative sales revenue for 2025 [12] - Lifang Pharmaceutical's subsidiary has obtained a drug registration certificate for a pain relief product [13] Group 5 - R&F Properties reported a total sales revenue of approximately 14.21 billion yuan for 2025 [14] - Wanfu Biology expects a net profit decline of 87.71% to 91.81% for 2025 [15] - Dazhi expects a negative net profit for 2025 [16] Group 6 - Dongzhu Ecology is negotiating to terminate the acquisition of control over a satellite communication company [17] - Baotai has received a milestone payment of 10 million USD from Hikma Pharmaceuticals [18] - Huace Navigation expects a net profit of 670 million to 690 million yuan for 2025, a year-on-year increase of 14.84% to 18.27% [19] Group 7 - Shenzhen Gas reported a net profit decline of 3.45% for 2025 [20] - Baogang Co. plans to adjust the price of rare earth concentrate for Q1 2026 to 26,834 yuan per ton [21] - Jiuding Investment expects to report a loss for 2025 [22] Group 8 - Shanghai Pharmaceuticals has received a drug registration certificate for a treatment for myasthenia gravis [23] - Hualan Biological plans to acquire a 35% stake in Guangfeng Capsule [24] - Ruina Intelligent plans to invest 169.9 million yuan in a new R&D production base for heat pumps [25] Group 9 - Wantong Development expects to report a loss for 2025 [26] - Xianghe Industrial has completed the purchase of a 5% stake in Hezhixiang Technology [27] - Guangkang Biochemical received a warning letter from the Guangdong Securities Regulatory Commission [28] Group 10 - Xiaoming Co. reported a 37.07% year-on-year decline in chicken product sales revenue for December 2025 [29] - Luokai Co. won a procurement project from State Grid Fujian Power worth approximately 48.2 million yuan [30] - Minhe Co. reported a 65.22% year-on-year increase in the sales of commodity chick seedlings for December 2025 [31] Group 11 - Zhenghai Biological has obtained a registration certificate for calcium silicate bio-ceramic materials [32] - Three Gorges Energy reported a 5.99% year-on-year increase in cumulative total power generation for 2025 [33] - Huisheng Biological expects a net profit of 235 million to 271 million yuan for 2025 [34] Group 12 - Maihe Co. announced the release of the detention measures against its chairman [35] - Wandong's Alzheimer's project has been included in a national major special project for innovative drug development [36] - Kangxin New Materials plans to transfer forest land assets with a book value of 1.203 billion yuan [37] Group 13 - Greenland Holdings expects a net loss of 16 billion to 19 billion yuan for 2025 [39] - Zhongxin Fluorine Materials has obtained a pesticide production license [40]
恒瑞医药:公司及子公司获批4个前列腺癌药物临床试验开展Ⅱ期研究
Hua Er Jie Jian Wen· 2026-01-09 09:42
Core Viewpoint - The company has received approval from the National Medical Products Administration for four drug clinical trials, focusing on prostate cancer-related multi-center, open-label Phase II clinical research [1] Drug Approval Summary - **SHR-4394 Injection**: - Indication: Prostate cancer - Cumulative R&D investment: 38.4 million yuan - No similar products approved domestically or internationally [1] - **HRS-5041 Tablets**: - A novel AR PROTAC small molecule for prostate cancer - Cumulative R&D investment: 92.66 million yuan - Potential to overcome drug resistance; no similar products available [1] - **Zemiglozole Tablets**: - EZH2 inhibitor, approved for market in 2025 - Cumulative R&D investment: 216.82 million yuan - Similar products expected to generate approximately 51 million USD in global sales by 2024 [1] - **Rivolumab Tablets**: - Second-generation AR inhibitor, approved in 2022 - Cumulative R&D investment: 696.72 million yuan - Similar products projected to achieve around 11.037 billion USD in global sales by 2024 [1]
恒瑞医药:四款药品获得药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2026-01-09 09:11
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of multiple drugs, indicating progress in its research and development pipeline [1]. Group 1 - The company announced on January 9 that it, along with its subsidiaries Chengdu Shengdi Pharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., has received clinical trial approval for SHR-4394, HRS-5041 tablets, SHR-2554 (Zemiglo), and Revlimid tablets [1]. - The clinical trials for these drugs are set to commence shortly, reflecting the company's ongoing commitment to expanding its product offerings and enhancing its market position [1].
医保影像云,索引上传已过亿;诺诚健华前三季度亏损6441万元
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-14 00:09
Policy Developments - The National Medical Insurance Administration announced that as of November 12, 2025, 24 provinces and regions in China have completed the deployment of the medical imaging cloud software, with 140 million indexed data uploaded to the national center [2] Drug and Device Approvals - Changchun High-tech's subsidiary received FDA approval for the clinical trial of GenSci143, a dual-specific antibody drug targeting B7-H3 and PSMA for treating advanced solid tumors [4] - Zai Lab announced that its ZG006 injection, in combination with etoposide and cisplatin, received clinical trial approval for advanced neuroendocrine carcinoma [5] - Heng Rui Medicine received approval for the clinical trial of Rivegromab tablets for prostate cancer [6] - Haisco announced that its HSK39297 tablets for age-related macular degeneration received clinical trial approval, showing promising preclinical results [7] Capital Market Activities - Kintor Pharmaceutical reported the repurchase of approximately 3.31 million shares since October 2025, with plans to repurchase up to 25.46 million shares over the next 50 trading days [9] - Changlian Co. signed an agreement to establish a joint venture with Shanghai Waigaoqiao Biopharmaceutical, contributing 30 million yuan for a 60% stake [10] Financial Reports - In the third quarter report, Nocera Biopharma reported a net loss of 64.41 million yuan for the first three quarters of 2025, despite a revenue increase of 59.85% to 1.115 billion yuan, driven by sales of its core product [12] Industry Events - The first China-Africa Joint Medical Center was established in Guinea, aiming to enhance healthcare collaboration and address cardiovascular diseases in West Africa [14] Shareholder Actions - Renhe Pharmaceutical's controlling shareholder plans to reduce its stake by up to 0.21% through public trading or block transactions [16]
港股公告掘金 | 京东集团-SW(09618)发布第三季度业绩,总收入2990.59亿元 同比增加14.85%
Zhi Tong Cai Jing· 2025-11-13 15:14
Major Events - Shanghai Industrial Holdings (00363) plans to sell 49% stake in Shanghai Shanshi Medical Beauty Hospital for 73.598 million yuan [1] - Hengrui Medicine (01276) received approval for clinical trial of Rivoceranib tablets [1] - CanSino Biologics (06185) initiated Phase I clinical trial of inhaled tuberculosis vaccine in Indonesia, completing the enrollment of the first subject [1] - Zhonghui Biotech-B (02627) started Phase I clinical trials for quadrivalent and trivalent influenza virus subunit vaccines [1] - Zhiyun Health (09955) signed a service cooperation agreement with JD Health (06618) to expand online sales and service channels for Livermore tablets and other P2M pipeline products [1] - China Resources Land (01109) plans to place shares of China Resources Mixc Lifestyle (01209) to diversify shareholder structure [1] - Shoucheng Holdings (00697) announced investment in Star Motion Era by Beijing Robotics Fund [1] Financial Performance - Tencent Holdings (00700) reported third-quarter revenue and profit growth, with non-IFRS profit attributable to shareholders reaching 70.551 billion yuan [1] - JD Group-SW (09618) reported third-quarter total revenue of 299.059 billion yuan, a year-on-year increase of 14.85% [1] - JD Logistics (02618) reported third-quarter revenue of 55.084 billion yuan, a year-on-year growth of 24.1% [1] - JD Health (06618) reported third-quarter operating profit of 1.243 billion yuan, a year-on-year increase of 125.3% [1] - SMIC (00981) reported third-quarter profit attributable to shareholders of approximately 192 million USD, a quarter-on-quarter increase of 44.7% and a year-on-year increase of 28.9% [1] - Bilibili-W (09626) reported a net profit of 469 million yuan in the third quarter, turning profitable year-on-year, with all core user metrics reaching historical highs [1] - China Pacific Insurance (02601) reported original insurance premium income of 241.322 billion yuan for the first ten months, a year-on-year increase of 9.9% [1]