榮昌生物(09995.HK):國家藥監局授予RC148突破性治療藥物認定用於治療非小細胞肺癌(NSCLC)
格隆匯8月19日丨榮昌生物(09995.HK)發佈公吿,公司原研的新型雙特異性抗體RC148被中國國家藥品監督管理局藥品審評中心(CDE)正式納入突破性治療藥物品種,針對適應症為:RC148聯合多西他賽治療經PD-1/PD-L1抑制劑和含鉑化療(聯合或序貫)治療失敗的驅動基因陰性局部晚期或轉移性非小細胞肺癌(NSCLC)。
此次被CDE納入突破性治療藥物品種,基於RC148一項在中國開展的多中心、開放性I/II期臨牀研究(RC148-C001)。該臨牀研究包括探索RC148聯合多西他賽治療既往經PD-1/PD-L1抑制劑和含鉑化療(聯合或續貫)治療失敗的NSCLC的療效和安全性,主要終點為客觀緩解率(ORR)等。研究結果顯示,在經PD-1/PD-L1抑制劑和含鉑化療(聯合或續貫)治療失敗的晚期NSCLC患者中,RC148聯合多西他賽展現出相比同類藥物或者標準治療更加優異的療效,且聯合治療安全性可控,耐受良好,有望為該人羣提供新的治療選擇。
突破性治療藥物是指用於防治嚴重危及生命或者嚴重影響生存質量的疾病,且尚無有效防治手段,或者與現有治療手段相比有足夠證據表明具有明顯臨牀優勢的創新藥或改良型藥物。對納入突破性治療藥物的創新藥,CDE將優先配置資源,新藥上市時間將大大縮短。本次被納入突破性治療品種認定,彰顯了RC148巨大的臨牀價值和開發潛力,將有助於加速RC148的臨牀開發進程,更快惠及廣大患者。
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