貝達藥業(300558.SZ):酒石酸泰瑞西利膠囊獲批上市
格隆匯7月2日丨貝達藥業(300558.SZ)公佈,今日,國家藥品監督管理局官方網站公示,國家藥監局批準貝達藥業股份有限公司申報的酒石酸泰瑞西利膠囊(BPI-16350,商品名:康美納®,以下簡稱“泰瑞西利”)上市。
泰瑞西利是由公司自主研發的全新的、擁有完全自主知識產權的新分子實體化合物,針對的靶點爲細胞週期蛋白依賴性激酶4/6(CDK4/6)。CDK4/6是調節細胞週期的關鍵因子,能夠觸發細胞週期從生長期(G1期)向DNA複製期(S期)轉變,泰瑞西利能特異性地和CDK4/6結合而抑制其激酶活性,抑制癌細胞增殖、轉移等相關的信號傳導,將細胞週期阻滯於G1期,從而起到抑制腫瘤細胞增殖的作用。本次獲批的適應症是聯合氟維司羣,適用於既往接受內分泌治療後進展的HR+/HER2-的局部晚期或轉移性成年乳腺癌患者。
截至本公告披露日,國內共有七款治療HR+/HER2-乳腺癌的CDK4/6抑制劑獲批,即輝瑞公司的哌柏西利、諾華公司的瑞波西利、禮來公司的阿貝西利、恆瑞醫藥的達爾西利、山東軒竹的吡洛西利、嘉和的來羅西利以及奧鴻藥業的伏維西利。泰瑞西利屬於“境內外均未上市的創新藥”,其註冊分類爲化學藥品1類。
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