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德琪醫藥-B(06996.HK):國家藥監局批准塞利尼索(ATG-010)在中國上市
格隆匯 12-17 08:03

格隆匯12月17日丨德琪醫藥-B(06996.HK)發佈公吿,塞利尼索(ATG-010)(商品名:希維®),同類首款口服SINE(選擇性核輸出蛋白抑制劑)藥物,正式獲得國家藥品監督管理總局的附條件上市批准,適用於與地塞米松聯用,既往接受過治療且對至少一種蛋白酶體抑制劑,一種免疫調節劑以及一種抗CD38單抗難治的復發或難治性多發性骨髓瘤成人患者的治療。

根據披露,希維奧®的有條件批准是基於全球二期STORM試驗以及在中國進行的二期 MARCH試驗的結果,MARCH試驗評估了塞利尼索聯合地塞米松(Sd)治療82例復發╱難治性多發性骨髓瘤(RRMM)患者的療效和安全性。STORM試驗結果顯示,在預先設定的亞組,即對硼替佐米、卡非佐米、來那度胺、泊馬度胺和達雷妥尤單抗均難治的83例受試者,由獨立審查委員會(IRC)根據國際骨髓瘤工作組(IMWG)療效標準評估的總緩解率(ORR),即主要終點,達到25.3%。

MARCH 試驗顯示,Sd方案治療對來那度胺、硼替佐米以及末線治療均難治(部份患者對 CD38單克隆抗體也難治)的中國患者,療效和安全性與全球研究的數據基本一致。MARCH試驗中,IRC評估所有接受治療患者的ORR(主要終點)達到29.3%,對至少一種蛋白酶體抑制劑、一種免疫調節劑和一種CD38單克隆抗體難治的患者的反應率為25%。

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