再鼎醫藥-SB(09688.HK):馬吉妥昔單抗的新藥上市申請已獲中國藥監局受理
格隆匯1月6日丨再鼎醫藥-SB(09688.HK)公佈,我們於2022年1月6日(美國東部時間)向美國證券交易委員會呈交表格8-K,以宣佈中國國家藥品監督管理局已受理馬吉妥昔單抗的新藥上市申請。馬吉妥昔單抗是一種靶向作用於HER2的Fc工程改造的新型單克隆抗體。馬吉妥昔單抗新藥上市申請涉及聯合化療用於治療已經接受過兩種或兩種以上抗HER2治療方案的轉移性HER2陽性乳腺癌成人患者,其中至少一種治療方案用於治療轉移性疾病。有關我們所呈交資料的進一步詳情,請參閲隨附的表格8-K。
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