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石藥集團(01093.HK):鹽酸米託蒽醌脂質體注射液療效數據令人驚喜
格隆匯 12-18 20:09

格隆匯12月18日丨石藥集團(01093.HK)公佈,由集團自主研發的鹽酸米託蒽醌脂質體注射液(HE071)用於治療復發/難治外周T細胞淋巴瘤(PTCL)和結外NK/T細胞淋巴瘤(ENKTCL)的有效性和安全性的臨牀研究數據摘要,於2020年美國血液學會(ASH)年會以口頭彙報方式呈列。該研究為鹽酸米託蒽醌脂質體注射液單藥治療(20mg/m2,每4周給藥1次,最多6個週期(n=108))的關鍵性、單臂、多中心II期臨牀研究。

臨牀研究數據顯示(截至2020年5月19日):其安全性較高,不良事件以血液學不良反應為主;入組的108例患者經IRC確認後的客觀緩解率(ORR)、完全緩解(CR)率 及 疾 病 控 制 率(DCR)分 別 為40.7%(44/108)、20.4%(22/108)及69.4%(75/108)。 在98例效果可評估的患者中經IRC確認後的ORR、CR率及DCR分別為44.9%(44/98)、22.4%(22/98)及76.5%(75/98);生存方面的優勢更加明顯;NKTCL亞型(n=21)患者的療效數據令人驚喜,經IRC確認後的ORR及DCR分別為 52.4%及76.2%。

據悉,鹽酸米託蒽醌脂質體注射液為集團自主研發的2類新藥,目前國內外暫無同劑型的產品上市或在研。集團已基於一項關鍵性註冊II期研究於中國遞交上市申請,2020年9月獲得受理並進入優先審評通道。

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