華東醫藥(000963.SZ)全資子公司獲得藥物臨牀試驗批准通知書
格隆匯8月1日丨華東醫藥(000963.SZ)發佈公吿,2021年7月29日,公司全資子公司杭州中美華東製藥有限公司(以下簡稱“中美華東”)收到國家藥品監督管理局(NMPA)核准簽發的《藥物臨牀試驗批准通知書》(通知書編號:2021LP01159 ),由中美華東和美國ImmunoGen, Inc. (以下簡稱“ImmunoGen”)申報的生物製品1類新藥IMGN853 (Mirvetuximab Soravtansine)另一中國關鍵性單臂臨牀試驗申請獲得批准。
根據披露,2020年10月20日,中美華東與美國ImmunoGen, Inc.達成獨家臨牀開發及商業化協議。中美華東將向ImmunoGen支付4000萬美元首付款和最高可達2.65億美元的里程碑付款,以及約定比例的銷售額提成費,獲得ImmunoGen美國臨牀III期在研產品Mirvetuximab Soravtansine(簡稱“MIRV”,新型抗體偶聯藥物ADC,用於治療卵巢癌)在大中華區的獨家臨牀開發及商業化權益。
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