Workflow
HENGRUI PHARMA(01276)
icon
Search documents
恒瑞医药(01276.HK):福建盛迪医药“注射用磷罗拉匹坦帕洛诺司琼”药品上市许可申请获受理
Ge Long Hui· 2026-01-30 11:24
Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for its drug application, indicating progress in the drug approval process [1] Group 1: Drug Information - The drug in question is Phosphorapitant Palonosetron Injection (HR20013) [1] - The dosage form is an injection [1] - The acceptance number for the application is CXHS2600019 [1] - The application is currently in the listing phase [1] Group 2: Indication - The proposed indication for the drug is to prevent acute and delayed nausea and vomiting in adult patients caused by moderately emetogenic anticancer drugs [1]
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
2026-01-30 11:16
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。 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30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。 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 ...
恒瑞医药:注射用磷罗拉匹坦帕洛诺司琼的药品上市许可申请获受理
Jin Rong Jie· 2026-01-30 09:13
Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of injectable fosnetupitant palonosetron, which is intended for the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer chemotherapy in adult patients [1] Group 1 - The drug is a compound formulation that can simultaneously activate NK-1 and 5-HT3 receptors to inhibit the vomiting reflex [1] - Currently, there are no similar injectable products approved for marketing in China [1] - The total research and development investment for this project is approximately 247 million yuan [1]
恒瑞医药:注射用磷罗拉匹坦帕洛诺司琼(HR20013)的药品上市许可申请获受理
Mei Ri Jing Ji Xin Wen· 2026-01-30 09:09
Core Viewpoint - Heng Rui Medicine (600276) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the drug application of HR20013, which is intended for the prevention of acute and delayed nausea and vomiting caused by moderately emetogenic anticancer drugs in adult patients [1] Group 1 - The drug HR20013 is specifically designed to address nausea and vomiting associated with cancer treatment [1] - The acceptance of the drug application marks a significant step towards potential market entry for Heng Rui Medicine [1] - This development highlights the company's ongoing commitment to expanding its oncology product portfolio [1]
恒瑞医药(600276) - 恒瑞医药关于药品上市许可申请获受理的提示性公告
2026-01-30 09:00
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-017 申请人:福建盛迪医药有限公司 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")子公司福建盛迪医 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》,公司注射用磷罗拉匹坦帕洛诺司琼(HR20013)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:注射用磷罗拉匹坦帕洛诺司琼 剂型:注射剂 受理号:CXHS2600019 申报阶段:上市 特此公告。 江苏恒瑞医药股份有限公司董事会 拟定适应症(或功能主治):本品用于成年患者预防中度致吐性抗肿瘤药物 引起的急性和迟发性恶心和呕吐。 二、药品的临床试验情况 此次申报新适应症,是基于一项评价注射用磷罗拉匹坦帕洛诺司琼用于预防 中度致吐性抗肿瘤药物引起恶心呕吐的有效性和安全性的多中心、随机、双盲、 阳性对照的Ⅲ期临床试验(HR20 ...
恒瑞医药(600276) - H股公告-翌日披露报表
2026-01-30 09:00
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2026年1月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股(於上海證券交易所上市) | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份(不包括庫存股份)數 目 | 佔有關事件 ...
从信达生物、恒瑞医药和百济神州,看Biopharma的估值区间
Xin Lang Cai Jing· 2026-01-30 08:57
Group 1 - The article discusses the transition of biotech companies to biopharma, emphasizing that biopharma companies have sales revenues sufficient to cover operational and future R&D costs [1][17][18] - It highlights the valuation differences between biotech and biopharma, noting that the value of a single pipeline at a 20% net margin is approximately equal to its peak sales, while post-acquisition by MNCs, the market value can reach 2-3 times [1][18] - The analysis includes companies like Innovent Biologics, Hengrui Medicine, and BeiGene to observe the relationship between biopharma's market value, revenue scale, and R&D capabilities [1][18] Group 2 - Innovent Biologics has transitioned from biotech to biopharma, requiring sales revenue to cover management, sales, and R&D expenses, with a minimum revenue target of 6 billion RMB [2][18] - The projected revenues for Innovent Biologics from 2022 to 2024 are 45.56 billion, 62.06 billion, and 94.22 billion RMB, respectively, with a net profit expected to turn positive by 2025 [3][19] - The company’s market value fluctuated between 429.12 billion and 875.89 billion RMB during this transition period [4][20] Group 3 - Hengrui Medicine is identified as a mature biopharma leader, with revenue and net profit figures for 2022 to 2025 showing consistent growth [5][21] - The revenue for Hengrui Medicine is projected to be 212.75 billion, 225.2 billion, and 279.85 billion RMB for 2022, 2023, and 2024, respectively, with a net profit of 39.06 billion RMB in 2022 [6][22] - The market value of Hengrui Medicine is expected to range from 2,286.46 billion to 4,723.01 billion RMB by 2025, reflecting its strong operational performance [7][22] Group 4 - BeiGene is characterized as an aggressive biopharma, with R&D expenses consistently exceeding 10 billion RMB, necessitating a revenue of at least 541.18 billion RMB to normalize its profit statement [8][23] - The projected revenues for BeiGene from 2022 to 2025 are 95.664 billion, 174.23 billion, and 272.14 billion RMB, with a peak market value of 3,535.05 billion HKD in 2025 [9][24] - Despite higher revenues, BeiGene's market value remains lower than Hengrui Medicine due to its abnormal profit statement [8][24] Group 5 - The article also discusses the valuation of Kangfang Biologics, which is projected to have a revenue of 64 billion RMB to normalize its profit statement, with a reasonable market value estimated between 640 billion and 1,024 billion HKD [10][25] - The revenue for Kangfang Biologics is expected to be 14.12 billion RMB in the first half of 2025, reflecting a growth of 33.67% [11][26] - The market value fluctuation for Kangfang Biologics in 2025 is anticipated to be between 454.17 billion and 1,504.50 billion RMB, indicating expectations of reaching breakeven as a biopharma [12][27] Group 6 - The article concludes that for companies transitioning from biotech to biopharma, a revenue range of 60-100 billion RMB and a market value of 500-1,000 billion RMB are significant benchmarks [28] - Initial assessments suggest that Innovent Biologics may be undervalued, while Kangfang Biologics' market value reflects expectations of overseas clinical approvals [28] - BeiGene's revenue surpasses that of Hengrui Medicine, yet its market value remains lower due to profit statement anomalies, indicating the need for further detailed research [28]
恒瑞医药:子公司注射用磷罗拉匹坦帕洛诺司琼新适应症上市许可申请获国家药监局受理
Hua Er Jie Jian Wen· 2026-01-30 08:56
恒瑞医药公告要点解读 核心事项 子公司福建盛迪医药的注射用磷罗拉匹坦帕洛诺司琼(HR20013)新适应症上市许可申请获国家药监局 受理(受理号:CXHS2600019)。 产品情况 新适应症:预防中度致吐性抗肿瘤药物引起的急性和迟发性恶心呕吐 已获批适应症:2025年5月已获批用于预防高致吐性化疗导致的恶心呕吐 市场地位:国内暂无同类注射剂获批上市,仅有口服胶囊制剂 临床数据 III期临床试验(96家中心,706例受试者)显示:延迟期和总体期完全缓解率均显著优于对照组,安全 性良好。 研发投入 累计研发投入约2.47亿元(未经审计)。 风险提示 药品上市存在不确定性,需关注后续审批进展。 ...
恒瑞医药(01276.HK)1月30日耗资1996万元回购34.31万股A股
Ge Long Hui· 2026-01-30 08:47
格隆汇1月30日丨恒瑞医药(01276.HK)发布公告,2026年1月30日耗资人民币1996万元回购34.31万股A 股,回购价格每股58.12-58.21元。 ...
恒瑞医药1月30日斥资1995.99万元回购34.31万股A股
Zhi Tong Cai Jing· 2026-01-30 08:23
恒瑞医药(600276)(01276)发布公告,于2026年1月30日,该公司斥资人民币1995.99万元回购34.31万 股A股股份,每股回购价人民币58.12-58.21元。 ...