和黃醫藥(00013.HK):他澤司他(tazemetostat)用於治療復發或難治性濾泡性淋巴瘤的中國新藥上市申請獲受理並獲納入優先審評
格隆匯7月4日丨和黃醫藥(00013.HK)發佈公吿,今日宣佈他澤司他(tazemetostat)用於治療復發或難治性濾泡性淋巴瘤成人患者的新藥上市申請已獲中國國家藥品監督管理局(“國家藥監局”)受理並予以優先審評。
他澤司他是由益普生(Ipsen)旗下公司Epizyme, Inc. (“Epizyme”)開發的全球同類首創的EZH2甲基轉移酶抑制劑,已獲美國食品藥品監督管理局(“FDA”)加速批准用於治療特定的復發/難治性濾泡性淋巴瘤患者以及特定的晚期上皮樣肉瘤患者。日本厚生勞動省亦已批准其用於治療特定的復發/難治性濾泡性淋巴瘤患者。和黃醫藥達成一項戰略合作,負責在中國內地、中國香港、中國澳門和中國台灣進行他澤司他的研究、開發、生產以及商業化。
一項在中國開展的多中心、開放標籤的II期橋接研究,以及Epizyme在中國以外地區開展的臨牀研究支持了此項中國新藥上市申請。他澤司他的臨牀急需進口藥品申請已於2022年5月獲批於海南博鰲樂城國際醫療旅遊先行區(簡稱“海南先行區”)使用,用於治療特定的上皮樣肉瘤和濾泡性淋巴瘤患者,與FDA已批准的標籤一致。他澤司他已於2023年3月在中國澳門特別行政區獲批使用,並於2024年5月在中國香港特別行政區獲批使用。
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