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康寧傑瑞製藥-B(09966.HK):JSKN003獲得國家藥監局突破性療法認定
格隆匯 03-18 08:04

格隆匯3月18日丨康寧傑瑞製藥-B(09966.HK)發佈公告,JSKN003獲得國家藥品監督管理局(“國家藥監局”)藥品審評中心突破性療法認定,用於治療鉑耐藥複發性上皮性卵巢癌(“PROC”)、原發性腹膜癌或輸卵管癌,且不限人表皮生長因子受體2(“HER2”)表達水平。

此次獲突破性療法認定,是基於JSKN003-101及JSKN003-102兩項臨牀研究的彙總分析結果。JSKN003-101爲一項於澳大利亞晚期╱轉移性實體瘤患者中開展的首次人體、開放性標籤和多中心的I期臨牀研究,分爲劑量遞增階段和劑量擴展階段。JSKN003-102爲一項於中國晚期實體瘤患者中開展的I期(劑量遞增及劑量擴展)及II期(隊列擴展)臨牀研究。JSKN003在該適應症的III期臨牀研究正處於入組階段,目前正在順利進行中。

JSKN003作爲新型雙特異性抗體偶聯藥物(“ADC”),利用酶催化和點擊化學反應的協同作用機制,提高血清穩定性和旁觀者殺傷效應的同時,展現出更加優異的療效。此次獲得突破性療法認定,有望加快JSKN003的臨牀開發和審評審批速度,早日使更多PROC患者獲益。

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