華東醫藥(000963.SZ)：生物製品1類新藥IMGN853臨牀試驗申請獲批
格隆匯 3 月 31日丨華東醫藥(000963.SZ)公佈，2021年3月30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《藥物臨牀試驗批准通知書》( 通知書編號：2021LP00412 )，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)”臨牀試驗申請獲得批准，包括一項國際多中心III期研究和一項評價中國成人患者中的安全性、耐受性和藥代動力學的I期研究。
適應症/功能主治：葉酸受體α高表達的鉑類耐藥的晚期高級別上皮性卵巢癌、原發性腹膜癌或輸卵管癌患者。
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(詳見公司2020-042號公吿)。
MIRV是一種抗體偶聯藥物(ADC)，包含FRα(葉酸受體)結合抗體、可裂解的連接子和美登木素生物鹼DM4，後者是一種強效的微管蛋白靶向劑。該產品是全球首個針對FRα陽性卵巢癌的ADC在研藥物，用於治療葉酸受體高表達的鉑類耐藥卵巢癌，屬於全球首創產品(First-in-class)，MIRV與FRα結合後，FRα可將MIRV轉移到細胞內部，從而其攜帶的細胞毒性分子DM4便可抑制癌細胞的有絲分裂，達到治療癌症的效果。美國IMGN853-0401(臨牀I期)及IMGN853-0403(臨牀III期)研究均一致得出FRα高表達卵巢癌更能從MIRV治療中獲益。
IMGN853目前還在開發多個聯合療法，包括與貝伐珠單抗、卡鉑等，可以進一步提高卵巢癌的響應率。Immuno Gen預計2021年下半年在美國遞交IMGN853的上市申請。IMGN853臨牀試驗申請已於2021年1月18日受理，有關詳情請見公司於2021年1月20日發佈的《關於公司藥品臨牀試驗申請獲得受理通知書的公吿》(公吿編號：2021-004)。
根據我國藥品註冊相關的法律法規要求，藥物在獲得臨牀試驗批準通知書後，尚需開展臨牀試驗並經國家藥品監督管理局審評、審批通過後方可生產上市。
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