SIHUAN PHARM(00460)

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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
作者:行情君 截至2024年年报,四环医药营业总收入19.01亿元、净利润-2.17亿元。 本文源自:金融界 8月19日,四环医药(00460)盘中下跌5.13%,截至14:26,报1.48元/股,成交9640.07万元。 四环医药控股集团有限公司是中国处方药市场的领先制药企业,主要业务为生产和销售心脑血管处方药 物,自2007年起一直是全国最大的心脑血管处方药物供应商。公司的关键经营数据包括独特的销售模 式、全国覆盖的销售网络、多元化的产品组合以及强大的研发能力。 ...
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) ...
港股异动|四环医药涨超10%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 05:37
Core Viewpoint - Four Seasons Pharmaceutical (0460.HK) experienced a significant intraday increase of over 10%, reaching a peak of 1.58 HKD, marking the highest level since February 2022 [1] Group 1: Company Developments - The company announced that its non-wholly owned subsidiary, Huisheng Biopharmaceutical Co., Ltd., has received acceptance for the market application of Semaglutide injection from the National Medical Products Administration (NMPA) for improving blood sugar control in adult patients with type 2 diabetes [1] - The clinical trial for Semaglutide injection's indication for weight loss has completed Phase III enrollment and is currently in the follow-up stage [1] Group 2: Competitive Position - Huisheng Biopharmaceutical is noted as the only biopharmaceutical company in China with a comprehensive product coverage in the diabetes and complications field, which enhances its competitive edge [1] - The company has nearly 20 approved diabetes and complications drugs in its product portfolio, and the richness of its research pipeline provides solid support for its long-term development [1]
港股异动 四环医药(00460)涨超9% 惠升生物旗下司美格鲁肽注射液上市申请获国家药监局受理
Jin Rong Jie· 2025-08-18 03:47
智通财经获悉,四环医药(00460)涨超9%,截至发稿,涨7.69%,报1.54港元,成交额1.13亿港元。 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。 据悉,糖尿病领域为惠升生物重点布局领域,本次司美格鲁肽注射液上市申请获国家药监局受理,是该 款药物研发进程中的又一重要进展,将有助于进一步提升集团和惠升生物在糖尿病治疗领域的核心竞争 力。 本文源自:智通财经网 ...
医保商保“双轨制”引爆创新药行情!港股创新药ETF(520690)单日飙2.5%,亚盛医药9%领涨
Xin Lang Cai Jing· 2025-08-18 02:55
Group 1 - The Hong Kong stock market experienced a rise and then a pullback, with the Hang Seng Index reaching a new high [1] - The National Healthcare Security Administration is publishing a list of drugs that have passed preliminary review for the "2025 National Medical Insurance Directory and Commercial Insurance Innovative Drug Directory," which will enter expert review and negotiation stages [1][2] - The Hong Kong Innovative Drug Selected ETF (520690) saw a nearly 2.5% increase, with a trading volume exceeding 20 million and a turnover rate over 5%, indicating strong market interest [1] Group 2 - The dual-track policy of basic medical insurance and commercial insurance for innovative drugs signals a payment closure model, suggesting that "true innovation is easier to scale" [2] - The performance of innovative drugs is expected to be positively impacted by the dual-track payment system and significant business development opportunities, leading to a systematic revaluation of the Chinese innovative drug sector [2] - The Hang Seng Medical ETF (513060) is benefiting from the dual advantages of technology penetration and market expansion, particularly in AI healthcare and innovative drug companies [3]