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石藥集團(01093.HK):JSKN003於中國獲突破性治療認定
格隆匯 03-18 08:06

格隆匯3月18日丨石藥集團(01093.HK)發佈公吿,公司附屬公司上海津曼特生物科技有限公司與江蘇康寧傑瑞生物製藥有限公司合作開發的JSKN003(一種靶向HER2雙表位的抗體偶聯藥物)獲中國國家藥品監督管理局授予突破性治療認定,擬定適應症為單藥用於鉑耐藥複發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌全人羣患者的治療(“該適應症”)。

卵巢癌年發病率位居中國女性生殖系統腫瘤第3位,病死率則位於女性生殖道惡性腫瘤之首,約70%的患者就診時已處於晚期。腫瘤細胞減滅術聯合術後含鉑化療是當前的主要治療手段,然而幾乎所有患者最終發展為對鉑類耐藥。對於鉑耐藥患者,非鉑類單藥化療為國內外指南推薦的主要治療方案,但療效十分有限,客觀緩解率(ORR)低,中位無進展生存期(PFS)和總生存期短,存在着巨大的尚未滿足的臨牀需求。JSKN003在該適應症的臨牀研究已初步顯示出療效突破,其安全性良好,與現有治療手段相比具有明顯臨牀優勢。

該適應症的III期臨牀試驗目前處於入組階段,現正順利進行中。JSKN003亦正在中國開展用於治療乳腺癌、胃癌、結直腸癌、膽道癌等實體瘤的多項II期及III期臨牀研究。JSKN003獲授予突破性治療認定,將有助於進一步加快其研發和審評速度,使其有望成為首個針對鉑耐藥卵巢癌全人羣患者的抗HER2治療藥物。

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