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四环医药(00460) - 2025 - 中期业绩
2025-08-29 04:16
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 對 因 本 公 告 全部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責 任。 Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 (於百慕達註冊成立的有限公司) (股份代號:0460) 截至二零二五年六月三十日止六個月 中期業績公告 四 環 醫 藥 控 股 集 團 有 限 公 司(「四環醫藥」或「本公司」)董 事(「董 事」)會(「董事會」) 欣 然 宣 佈 本 公 司 及 其 附 屬 公 司(統 稱「本集團」)截 至 二 零 二 五 年 六 月 三 十 日 止 六 個 月(「期 內」)的 未 經 審 核 綜 合 業 績 連 同 截 至 二 零 二 四 年 六 月 三 十 日 止 六 個 月 的 比 較 數 字。該 中 期 簡 明 綜 合 財 務 資 料 已 經 由 本 公 司 的 外 部 核 數 師 安 永 會 計師事務所根據國際審計和核證準則委員會頒佈的國際審閱業 ...
四环医药(00460):轩竹生物自研创新药地罗阿克片获国家药监局上市批准
智通财经网· 2025-08-22 12:32
Core Viewpoint - The approval of the innovative ALK inhibitor, Dirocitinib (formerly known as "Dazatinib"), by the National Medical Products Administration (NMPA) in China marks a significant advancement for the company in the oncology field, particularly for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2]. Group 1: Product Approval and Significance - The product is the third class 1 innovative drug approved for the company and the second innovative oncology drug, showcasing the company's continuous progress in targeted therapies from breast cancer to lung cancer [1]. - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1]. Group 2: Clinical Breakthroughs - Dirocitinib successfully addresses clinical challenges by controlling brain metastases and ensuring safety, effectively penetrating the blood-brain barrier [2]. - The safety profile of Dirocitinib shows significant advantages, with adverse reactions primarily being mild gastrointestinal issues, which can be managed through symptomatic treatment or dose adjustments [2].
四环医药:轩竹生物自研创新药地罗阿克片获国家药监局上市批准
Zhi Tong Cai Jing· 2025-08-22 12:31
Core Viewpoint - The approval of the innovative ALK inhibitor drug, Dirocitinib (formerly known as "Dahisitinib"), by the National Medical Products Administration (NMPA) in China marks a significant advancement for the company in the oncology field, particularly for treating ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Approval and Significance - The drug Dirocitinib is the third innovative drug approved for market by the company's subsidiary, Xuan Zhu Bio-Tech, and the second innovative oncology drug, showcasing the company's continuous progress in targeted therapies from breast cancer to lung cancer [1] - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1] Group 2: Clinical Breakthroughs - Dirocitinib successfully addresses clinical challenges by controlling brain metastases and ensuring safety, effectively penetrating the blood-brain barrier and compensating for existing therapies' shortcomings in central nervous system protection [2] - The drug demonstrates significant safety advantages, with adverse reactions primarily being mild gastrointestinal issues, which can be managed through symptomatic treatment or dose adjustments, leading to improved long-term medication adherence among patients [2]
四环医药(00460.HK):轩竹生物自研创新药地罗阿克片获国家药监局上市批准
Ge Long Hui· 2025-08-22 12:22
Core Viewpoint - The approval of the innovative ALK inhibitor, Dirocitinib (formerly known as "Dahitinib"), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Xuan Bamboo Biotechnology and provides a breakthrough treatment option for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Approval and Significance - Dirocitinib is the third innovative drug approved for Xuan Bamboo Biotechnology and the second innovative oncology drug, showcasing the company's continuous advancement in targeted therapies from breast cancer to lung cancer [1] - The approval represents an important research and development milestone for Xuan Bamboo's innovative drug pipeline, contributing to the acceleration of cancer prevention and treatment goals under the "Healthy China 2030" initiative [2] Group 2: Drug Advantages - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1] - The drug effectively penetrates the blood-brain barrier, addressing existing therapies' shortcomings in central nervous system protection, while demonstrating a favorable safety profile with manageable side effects [2] Group 3: Clinical Impact - In pivotal Phase III clinical trials, Dirocitinib showed significant efficacy compared to existing first- and second-generation ALK inhibitors, particularly against resistant mutations such as G1202R and I1171N [1] - The drug's safety profile includes primarily mild gastrointestinal reactions, with reduced risks of pleural effusion and hepatotoxicity, enhancing long-term medication adherence among patients [2]
四环医药(00460) - 自愿公告-轩竹生物自研创新药地罗阿克片获国家药监局上市批准
2025-08-22 12:05
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之內容概不 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 全部或任何部份內容而產生或因倚賴該等內容而引致之任何損失承擔任何責 任。 自願公告 軒竹生物自研創新藥地羅阿克片獲國家藥監局上市批准 四 環 醫 藥 控 股 集 團 有 限 公 司(「本公司」或「四環醫藥」,連 同 其 附 屬 公 司,統 稱 為 「本集團」)董 事 會(「董事會」)欣 然 宣 佈,本 集 團 旗 下 非 全 資 附 屬 公 司 軒 竹 生 物 科 技 股 份 有 限 公 司(「軒竹生物」)自 主 研 發 的ALK抑制劑1類 創 新 藥 地 羅 阿 克 片(曾 用 名「達 希 替 尼」,XZP-3621,商 品 名:軒 菲 寧®)獲 得 中 國 國 家 藥 品 監 督 管 理 局 (NMPA)批 准 上 市,用 於 治 療 間 變 性 淋 巴 瘤 激 酶(ALK)陽性的晚期非小細胞肺癌 (NSCLC)。該產品是軒竹生物第三個獲批上市的1類 創 新 藥,同 時 也 是 軒 竹 生 物 第二個獲批上市的1類 ...
速递|国产+1!四环医药惠升生物司美格鲁肽申报上市
GLP1减重宝典· 2025-08-20 03:07
Core Viewpoint - The article discusses the recent developments in the GLP-1 drug market, particularly focusing on the approval and clinical trials of semaglutide for weight loss and diabetes management by Four Rings Pharmaceutical and its subsidiary Huisheng Biotech [2][4]. Company Overview - Four Rings Pharmaceutical is a comprehensive pharmaceutical company involved in research, production, sales, and medical aesthetics, evolving through four stages to establish a dual-engine model of "pharmaceuticals + medical aesthetics" [6]. - The company has a history of significant growth, with a compound annual growth rate (CAGR) that has outpaced the industry from 2001 to 2010, and has expanded its operations through acquisitions and upgrades [6]. - As of now, Four Rings has over 600 research personnel and more than 120 new drugs in development, with over 300 patents granted [7]. Product Development - Semaglutide, a new long-acting GLP-1 receptor agonist, has shown dual effects in lowering blood sugar and controlling weight by promoting insulin secretion and suppressing appetite [4]. - The "weight loss version" of semaglutide has completed its Phase III clinical trial enrollment and is now in the follow-up stage [2]. - The core component patent for semaglutide in China will expire in March 2026, with seven companies having their related applications accepted, focusing primarily on Type 2 diabetes treatments [5]. Market Competition - Novo Nordisk has been an early player in this market, with its diabetes injection product, Ozempic, approved in April 2021, followed by oral and weight loss versions in 2024 [5]. - The competitive landscape includes various companies pursuing different registration classifications and technical routes for semaglutide-related products [5].
四环医药(00460.HK)拟8月29日举行董事会会议批准中期业绩
Ge Long Hui· 2025-08-19 09:07
格隆汇8月19日丨四环医药(00460.HK)宣布,本公司将于2025年8月29日(星期五)举行董事会会议,藉 以(其中包括)批准本公司及其附属公司截至2025年6月30日止六个月的中期业绩及其发布,并讨论及 通过(如适用)派发中期股息。 ...
四环医药(00460) - 董事会会议通知
2025-08-19 08:51
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 對 因 本 公 告 全部或任何部份內容而產生或因依賴該等內容而引致的任何損失承擔任何責 任。 Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 (於百慕達註冊成立的有限公司) (股份代號:0460) 董事會會議通知 四 環 醫 藥 控 股 集 團 有 限 公 司(「本公司」)董 事 會(「董事會」)謹 此 宣 佈,本 公 司 將 於 二 零 二 五 年 八 月 二 十 九 日(星 期 五)舉 行 董 事 會 會 議,藉 以(其 中 包 括)批 准 本 公 司 及 其 附 屬 公 司 截 至 二 零 二 五 年 六 月 三 十 日 止 六 個 月 之 中 期 業 績 及 其 發 佈, 並 討 論 及 通 過(如 適 用)派 發 中 期 股 息。 承董事會命 四環醫藥控股集團有限公司 主席兼執行董事 車馮升醫生 香 港,二 零 二 五 年 八 月 十 九 日 於 本 公 告 日 期,本 ...
四环医药(00460)下跌5.13%,报1.48元/股
Jin Rong Jie· 2025-08-19 06:45
Core Viewpoint - The stock price of Sihuan Pharmaceutical (00460) has decreased by 5.13% as of August 19, with a trading price of 1.48 CNY per share and a transaction volume of 96.40 million CNY [1]. Group 1: Company Overview - Sihuan Pharmaceutical Holdings Group Co., Ltd. is a leading pharmaceutical company in China's prescription drug market, primarily engaged in the production and sales of cardiovascular prescription drugs [1]. - Since 2007, the company has been the largest supplier of cardiovascular prescription drugs in the country [1]. - Key operational data includes a unique sales model, a nationwide sales network, a diversified product portfolio, and strong research and development capabilities [1]. Group 2: Financial Performance - As of the 2024 annual report, Sihuan Pharmaceutical reported total revenue of 1.901 billion CNY and a net profit of -217 million CNY [2].
四环医药涨超10%最高触及1.58港元,股价创近三年半新高!附属公司司美格鲁肽注射液上市申请获药监局受理
Ge Long Hui· 2025-08-18 06:06
消息面上,四环医药公布,集团旗下非全资附属公司惠升生物制药股份有限公司开发的司美格鲁肽注射 液上市申请获得国家药品监督管理局(NMPA)受理,用于改善成人2型糖尿病患者的血糖控制。此外,司 美格鲁肽注射液用于减重的适应症已完成III期临床入组,处于随访阶段。 【免责声明】本文仅代表作者本人观点,与和讯网无关。和讯网站对文中陈述、观点判断保持中立,不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考,并请自行承担全部责任。邮箱: news_center@staff.hexun.com 格隆汇8月18日|四环医药(0460.HK)盘中一度涨超10%,最高触及1.58港元,创2022年2月以来新高。 (责任编辑:宋政 HN002) 据悉,作为国内唯一在糖尿病及并发症领域实现全产品覆盖的生物医药企业,惠升生物的产品矩阵已形 成显著竞争力。除司美格鲁肽的几个在研管线外,公司已有近20款糖尿病及并发症药物获批上市,研发 管线的丰富性为其长期发展提供了坚实支撑。(格隆汇) ...