库莫西利胶囊(赛坦欣®)
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中国生物制药(01177) - 自愿公告 - 「库莫西利胶囊」获批上市
2025-12-12 08:53
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,概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 (於開曼群島註冊成立之有限公司) 網站:www.sinobiopharm.com (股份編號:1177) 自願公告 「庫莫西利膠囊」獲批上市 中國生物製藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董事會」)宣佈,本集團自 主研發的國家1類創新藥庫莫西利膠囊 (商品名:賽坦欣®) 已獲得中國國家藥品監督管理局 (NMPA) 的上市批准,用於與氟維司群聯合治療既往接受內分泌治療後出現疾病進展的激素受體 (HR) 陽性、 人表皮生長因子受體2 (HER2) 陰性的局部晚期或轉移性乳腺癌患者。 參考文獻: 承董事會命 庫莫西利是全球首創的同時靶向CDK2/4/6的三重抑制劑,對CDK2、CDK4、CDK6激酶有不同程度 的抑制效果,且對CDK4激酶有較強的選擇性抑制能力。基於其獨特的作用機制,庫莫西利不僅有助 於延緩臨床中CDK4/6抑制劑的耐藥問題,還可以減輕骨髓抑制風險[1]。 在關鍵I ...
金城医药实控人收到行政处罚决定书;新诺威递交H股上市申请
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-12 00:10
Group 1: Industry Developments - Jiangsu Province has officially released its 15th Five-Year Plan, emphasizing the enhancement of industries such as biomedicine, new generation information technology, and high-end equipment, aiming to cultivate strategic emerging industry clusters with international competitiveness [1] - The global first CDK2/4/6 inhibitor, Kimosir, developed by China National Pharmaceutical Group's subsidiary, has been approved for marketing, marking a significant advancement in targeted therapy for breast cancer in China [1] - The innovative drug, Simoziran, developed by Shanghai Pharmaceuticals, has been approved for the treatment of primary hypertension, representing a new addition to the hypertension treatment market [2] Group 2: Company Announcements - Health元 has received a drug registration certificate for its innovative anti-influenza drug, Marpacisavir, which is effective for treating influenza A and B in adolescents and adults, showcasing significant advantages in efficacy and safety [3] - Baijun Medical's subsidiary has received approval for its collagen implant product, the first of its kind in China for improving facial smoothness, highlighting the company's innovation in the collagen field [4] - Innovent Biologics has announced the approval of its next-generation TRK inhibitor, Zoltritinib, for treating adult and adolescent patients with NTRK fusion gene solid tumors, marking a milestone in China's oncology market [5] Group 3: Market Movements - Saili Medical has reported a reduction in shareholding by Shanghai Anze Private Equity Fund to 5.00%, indicating a strategic shift in investment [6][7] - Newnow has submitted an application for H-share listing on the Hong Kong Stock Exchange, reflecting the trend of innovative pharmaceutical companies seeking dual listings [8] - Yunding New Medicine has entered into strategic cooperation with Haishen Biopharmaceuticals, enhancing its commercialization capabilities in the cardiovascular field through service and licensing agreements [9]