中國生物製藥(01177.HK)：KRAS G12C抑制劑"GARSORASIB(D-1553片)"新藥上市申請獲得受理
格隆匯1月2日丨中國生物製藥(01177.HK)宣佈，由集團聯合開發的KRAS G12C抑制劑"Garsorasib(D-1553片)"的新藥上市申請(NDA)已獲得中國國家藥品監督管理局正式受理，用於既往經一線系統治療後疾病進展或不可耐受的、並且經檢測確認存在KRASG12C突變的局部晚期或轉移性非小細胞肺癌(NSCLC)的治療。目前，國內尚無靶向KRAS G12C的藥物上市。
D-1553是國內首個自主研發並進入臨牀試驗階段的KRAS G12C抑制劑，並在美國、澳大利亞、中國、韓國等多個國家及地區開展了國際多中心臨牀試驗。2022年6月，D-1553被國家藥品監督管理局藥品審評中心(CDE)納入突破性治療品種，是首個獲得CDE突破性治療認定的國產KRAS G12C抑制劑。此次NDA受理是基於一項在中國開展的臨牀II期單臂註冊[CTR20220745]研究結果。該研究旨在評估D-1553單藥在標準治療失敗或不耐受且KRAS G12C突變的晚期NSCLC受試者中的安全性、耐受性和療效，研究結果將在後續的學術期刊╱學術會議上予以公佈。
與國際上已獲批上市的同靶點藥物相比，D-1553的療效和安全性名列前茅。早期臨牀研究結果顯示，D-1553在攜帶KRAS G12C突變的NSCLC患者中具有良好的安全性和抗腫瘤活性，客觀緩解率(ORR)為40.5%，疾病控制率(DCR)為91.9%，中位無進展生存期(mPFS)為8.2個月，mPFS高於此前獲得美國食品藥品監督管理局(FDA)批准的同靶點藥物。該早期臨牀結果入選2022年世界肺癌大會(WCLC)口頭報吿，並於2023年4月發表於Journal of Thoracic Oncology (JTO)。
KRAS突變廣泛存在於多個高致死率癌種中，其中，KRAS G12C是最常見的KRAS突變之一，約佔所有KRAS突變的44%。KRAS G12C突變在肺癌、結直腸癌、胰腺癌及膽管癌中較為常見。2016至2020年，中國主要KRAS G12C突變癌種的新發患者數量從3.8萬增長至4.3萬，預計2030年將達到5.8萬。目前，KRAS G12C突變患者的預後較差，而且對標準療法容易產生耐藥性，一旦化療或免疫治療失敗，治療選擇十分有限，存在極大的未滿足的臨牀需求。
D-1553潛在適應症空間大，在此次NDA受理的適應症之外，集團正在與益方生物科技(上海)股份有限公司("益方生物")合作推進一線NSCLC等多個實體腫瘤的臨牀試驗，預計將於未來幾年進一步拓展D-1553的適應症，有望打造出下一個比肩安羅替尼級別的重磅腫瘤產品。
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