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技术赋能、全球化驱动,美迪西三季度业绩稳中有进、加速回暖
Cai Fu Zai Xian· 2025-11-03 10:39
Core Insights - Shanghai Medicilon Biopharma Co., Ltd. reported a revenue of 843 million yuan for the first three quarters of 2025, marking a year-on-year increase of 5.14% [1] - The company achieved a net profit of -29.68 million yuan for the same period, a significant reduction in losses by 76.93% compared to the previous year [1] - Medicilon's cash flow from operating activities turned positive, reaching 42.48 million yuan, reflecting a 161.79% year-on-year increase [1] Financial Performance - Revenue for Q3 2025 was 303 million yuan, showing a year-on-year growth of 7.94% and a quarter-on-quarter increase of 10.70% [1] - The net profit for Q3 was -16.79 million yuan, indicating a 71.28% improvement in loss reduction compared to the same quarter last year [1] Innovation and R&D - Medicilon's innovation platform, which integrates AI-driven services, is crucial for enhancing efficiency and attracting client orders [2] - The AI drug discovery platform has successfully assisted multiple innovative drugs in entering clinical trials [2] - The company holds a total of 47 patents, with 7 new patents granted in the first half of 2025, demonstrating its commitment to high investment and efficient R&D [2] Global Expansion - The proportion of overseas revenue increased to 46.54% in the first three quarters of 2025 [3] - Medicilon's Boston laboratories are fully operational, providing services that meet both Chinese and U.S. regulatory standards [3] - The company has successfully passed inspections from major international regulatory bodies, enhancing its global research capabilities [3] Strategic Collaborations - Medicilon has deepened its collaboration with leading domestic pharmaceutical companies, enhancing its capabilities in cutting-edge technology areas [4] - The company has supported several partners in obtaining regulatory approvals for innovative drugs, showcasing its comprehensive technical service capabilities [5] Industry Outlook - The global CRO market is projected to reach $106.45 billion by 2026 and $147.73 billion by 2030, with a compound annual growth rate of approximately 6.6% [5] - The Chinese government has introduced policies to support the CRO industry, providing long-term growth momentum [5]
11月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-03 10:18
Group 1 - Karen Co., Ltd. signed a device procurement contract worth 198 million yuan with BOE Technology Group's subsidiary [1] - Pingzhi Information's subsidiary signed a procurement framework agreement with China Telecom totaling approximately 74 million yuan [1] - Huaxin Environmental Protection obtained a loan commitment of 72 million yuan from China Minsheng Bank for stock repurchase [2] Group 2 - Sichuan Gold obtained a mining license for the Suoluo Gold Mine area [3] - *ST Huifeng's subsidiary, Kofit Company, is undergoing bankruptcy liquidation [4] - Blue Arrow Electronics decided to terminate and exit a joint investment project due to market changes [6] Group 3 - Junhe Materials is planning to issue H-shares and list on the Hong Kong Stock Exchange [7] - Longping High-Tech reported a 2.41% year-on-year decline in total revenue for the period from October 1, 2024, to September 30, 2025 [8] - Hongsheng Huayuan's subsidiary is a candidate for a 584 million yuan project with the State Grid [10] Group 4 - Weisheng Information won multiple projects in the power and public utility sectors, totaling 89.94 million yuan [12] - Heng Rui Pharmaceutical received approval for a clinical trial of a combination therapy for prostate cancer [13] - Saito Bio's subsidiary received approval for the listing of a raw material drug [15] Group 5 - Aikang Pharmaceutical's application for a new drug was accepted by the National Medical Products Administration [16] - Chengfa Environment was selected as a supplier for a waste-to-energy project in Indonesia [16] - Dalian Electric Porcelain's subsidiary is a candidate for a 59 million yuan project with the State Grid [17] Group 6 - Denghai Seed reported a 20.01% year-on-year decline in revenue for the 2024-2025 business year [18] - Tongda Co., Ltd. is a candidate for a 133 million yuan project with the State Grid [20] - Hanma Technology's electric heavy-duty truck sales increased by 325.7% year-on-year in October [21] Group 7 - Cap Bio received a patent for a microfluidic chip for live cell sorting [21] - Renfu Pharmaceutical's subsidiary received approval for a clinical trial of a drug for postherpetic neuralgia [22] - Daon Co., Ltd. received approval for a share issuance to acquire 100% of Daon Titanium Industry [22] Group 8 - Han Jian Heshan signed a procurement contract for reinforced concrete drainage pipes worth 207 million yuan [23] - Haisike's innovative drug HSK39297 received approval for clinical trials [25] - Tongguang Cable is a candidate for a 138 million yuan project with the State Grid [27] Group 9 - Jiuqiang Bio received medical device registration certificates for two new products [29] - Visionox is planning a change of control and has suspended trading [30] - Shenyu Co., Ltd. received approval for a convertible bond issuance [31] Group 10 - Metro Design's asset restructuring has resumed review by the Shenzhen Stock Exchange [33] - BAIC Blue Valley's private placement application was approved by the Shanghai Stock Exchange [34] - Seris set the H-share issuance price at 131.50 HKD per share, with listing on November 5 [35]
恒瑞医药(01276.HK):瑞维鲁胺片获得药物临床试验批准通知书
Ge Long Hui· 2025-11-03 10:12
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of Rivoceranib tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Group 1: Product Development - Rivoceranib tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] Group 2: Market Context - Rivoceranib tablets are entering a competitive market with other second-generation AR inhibitors such as Enzalutamide, Apalutamide, and Darolutamide already available [1] - According to EvaluatePharma, the global sales for similar products are projected to reach approximately $11.037 billion in 2024 [1] Group 3: Investment and R&D - The cumulative R&D investment for Rivoceranib tablets has reached approximately 693.09 million yuan [1]
恒瑞医药(01276):HRS-5965 胶囊拟纳入优先审评程序
智通财经网· 2025-11-03 10:10
Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical's HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration [1] Group 1: Product Information - HRS-5965 capsules are a complement factor B inhibitor designed to suppress complement-mediated hemolytic reactions and improve hemoglobin levels [1] - The target indication is Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare acquired hemolytic disease characterized by the lack of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] Group 2: Market Context - PNH has been included in the national list of rare diseases due to its low incidence/prevalence [1] - Currently, the only drug approved for this indication is Novartis' Iptacopan (Fabhalta®), which is projected to have a global sales revenue of approximately $129 million in 2024 according to EvaluatePharma [1] Group 3: R&D Investment - The cumulative R&D investment for the HRS-5965 project has reached approximately 209.94 million yuan [1]
恒瑞医药(01276):瑞维鲁胺片获准开展临床试验
智通财经网· 2025-11-03 10:09
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Rivolumab tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Company Summary - Rivolumab tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] - Cumulative R&D investment in Rivolumab tablets has reached approximately 693 million yuan [1] Industry Summary - The global sales of similar second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, are projected to total approximately 11.037 billion USD in 2024 [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
2025-11-03 10:03
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。 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) 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。 中國上海 2025年11月3日 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 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。 受 理 号:CXHL2500815 审批结论:根据《中华人民共和国药品管 ...
恒瑞医药(01276.HK):子公司HRS-5965胶囊拟纳入优先审评程序
Ge Long Hui· 2025-11-03 09:59
剂型:胶囊剂 格隆汇11月3日丨恒瑞医药(01276.HK)公告,近日,江苏恒瑞医药股份有限公司子公司成都盛迪医药有 限公司的 HRS-5965 胶囊被国家药品监督管理局药品审评中心(以下简称"药审中心")拟纳入优先审评品 种公示名单,公示期 7 日。现将相关情况公告如下: 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成人患者。 一、药物的基本情况药物名称:HRS-5965 胶囊 申请人:成都盛迪医药有限公司 拟优先审评理由:经审核,申请符合《药品注册管理办法》和《国家药监局关于发布<突破性治疗药物 审评工作程序(试行)>等三个文件的公告》(2020年第 82 号)有关要求,同意按优先审评范围"(一)临床急 需的短缺药品、防治重大传染病和罕见病等疾病的创新药和改良型新药"纳入优先审评审批程序。 ...
恒瑞医药(01276) - 海外监管公告 - 关於回购公司A股股份的进展公告
2025-11-03 09:59
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。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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 2025年11月3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。 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) 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。 江苏瑞医药股份有限公司(以下简称"公司")于 2025 年 8 月 20 ...
恒瑞医药(01276) - 海外监管公告 - 关於药物拟纳入优先审评程序的公告
2025-11-03 09:53
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。 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。 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) 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 2025年11月3日 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-16 ...
恒瑞医药瑞维鲁胺片临床试验获批
Bei Jing Shang Bao· 2025-11-03 09:33
北京商报讯(记者 王寅浩 宋雨盈)11月3日,恒瑞医药发布公告称,公司近日收到国家药品监督管理局 核准签发关于瑞维鲁胺片的《药物临床试验批准通知书》,同意该品开展联合注射用HS-20093用于前 列腺癌的临床试验。 公告显示,瑞维鲁胺片是第二代AR抑制剂,相较于第一代AR抑制剂,具有更强的AR抑制作用,且无 激动作用。恒瑞医药瑞维鲁胺片已于2022年获批上市,用于治疗高瘤负荷的转移性激素敏感性前列腺癌 (mHSPC)患者。 ...