泽美妥司他片是公司开发的新型、高效、选择性的口服EZH2抑制剂,已于2025年获批上市，用于治疗既 往接受过至少1线系统性治疗的复发或难治外周T细胞淋巴瘤(R/R PTCL)成人患者。目前国内外同类产 品有他泽司他(Tazemetostat，EZH2抑制剂)和伐美妥司他(Valemetostat，EZH1/2抑制剂)获批上市。经查 询EvaluatePharma数据库，2024年Tazverik全球销售额合计约为5100万美元。截至目前，泽美妥司他片 相关项目累计研发投入约2.17亿元。 恒瑞医药（600276）(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")及子公司成 都盛迪医药有限公司、上海恒瑞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SHR-4394、HRS-5041片、泽美妥司他片(SHR2554)、瑞维鲁胺片的《药物临床试验批准 通知书》，将于近期开展临床试验。 注射用SHR-4394是公司自主研发的一款治疗用生物制品，拟用于治疗前列腺癌。经查询，国内外尚无 同类产品获批上市。截至目前，注射用SHR-4394相关项目累计研发投入约为38 ...

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]

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]

北京商报讯（记者 王寅浩 宋雨盈）1月9日，恒瑞医药发布公告称，公司及子公司成都盛迪医药有限公 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SHR-4394、HRS-5041片、泽 美妥司他片（SHR-2554）、瑞维鲁胺片的《药物临床试验批准通知书》，将于近期开展临床试验。具 体为SHR-4394或HRS-5041联合抗肿瘤治疗在前列腺癌参与者中的安全性、耐受性及有效性的多中心、 开放Ⅱ期临床研究。 ...

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]

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]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-006 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 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"）子公司成都盛迪医 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"）下发的《受理 通知书》，公司富马酸立康可泮（HRS-5965）胶囊的药品上市许可申请获国家药 监局受理。现将相关情况公告如下： 一、药品的基本情况 药品名称：富马酸立康可泮胶囊 剂型：胶囊剂 受理号：CXHS2600014 申报阶段：上市 申请人：成都盛迪医药有限公司 拟定适应症（或功能主治）：治疗既往未接受过补体抑制剂治疗的阵发性睡 眠性血红蛋白尿症（PNH）成人患者。 二、药品的临床试验情况 此次申报上市，是基于一项在既往未接受过补体抑制剂治疗的 PNH 患者中进 行的关键研究（HRS-5965-301）。该研究是一项评估 HRS-5965 胶囊对比依库珠 单抗用于治疗既往未接受过补体抑制剂治疗的 PNH 患者的 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-005 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"）及子公司成都盛迪 医药有限公司、上海恒瑞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 SHR-4394、HRS-5041 片、泽美妥司他片 （SHR-2554）、瑞维鲁胺片的《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： 二、药物的其他情况 注射用 SHR-4394 是公司自主研发的一款治疗用生物制品，拟用于治疗前列 腺癌。经查询，国内外尚无同类产品获批上市。截至目前，注射用 SHR-4394 相 关项目累计研发投入约为 3,840 万元。 HRS-5041 片是公司开发的新型、高效、选择性的 AR PROTAC（雄激素受体- 蛋白降解靶向嵌合体）小分子，拟用于治疗前列腺癌。HRS-5041 片对野生型及 药物名称 注射用 SHR ...

人民财讯1月9日电，恒瑞医药（600276）1月9日公告，近日，子公司成都盛迪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")下发的《受理通知书》，公司富马酸立康可泮(HRS-5965)胶囊的 药品上市许可申请获国家药监局受理。 ...

人民财讯1月9日电，恒瑞医药（600276）1月9日公告，近日，公司及子公司成都盛迪医药有限公司、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SHR-4394、HRS-5041片、泽美妥司 他片(SHR-2554)、瑞维鲁胺片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...