華東醫藥(000963.SZ):生物製品1類新藥IMGN853另一中國關鍵性單臂臨牀試驗申請獲受理
格隆匯5月27日丨華東醫藥(000963.SZ)公佈,2021年5月26日,公司全資子公司杭州中美華東製藥有限公司(“中美華東”)收到國家藥品監督管理局(NMPA)核准簽發的《受理通知書》(受理號:JXSL2101035國),由中美華東和美國ImmunoGen, Inc. (“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受理。
此次獲得受理的為中國關鍵性單臂臨牀試驗,患者入選標準包括FRα高表達、先前已接受過至多3種治療方案且至少接受過一種含貝伐珠單抗的治療的鉑耐藥卵巢癌患者。
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