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科倫藥業(002422.SZ):用於RET融合或突變的晚期實體瘤治療的創新藥物KL590586膠囊獲批臨牀試驗
格隆匯 06-08 20:29

格隆匯6月8日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的創新藥物KL590586膠囊獲得國家藥品監督管理局(NMPA)臨牀試驗通知書。

審評結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021 42日受理的KL590586 膠囊符合藥品註冊的有關要求,同意本品在RET因融合或突變的晚期實體瘤中進行臨牀試驗。

KL590586膠囊是公司研發的小分子選擇性靶向RET激酶抑制劑,靶點成熟,作用機制明確,擬用於RET融合或突變的晚期實體瘤的治療是公司研發的首個泛瘤種的精準治療藥物。

RET基因融合或突變是導致多種實體腫瘤生長和增殖的關鍵驅動因子,2020年,兩款高選擇性RET抑制劑Retevmo® (LOXO-292)和GAVRETO® (BLU-667)相繼通過FDA加速批准上市,用於治療RET融合非小細胞肺癌,RET突變甲狀腺髓樣癌和RET融合其他類型甲狀腺癌。

KL590586膠囊於2018Q3立項,具有全新的化合物結構及自主知識產權,臨牀前研究表明,KL590586膠囊對RET激酶具有高選擇性,在動物模型中顯示出良好的抗腫瘤活性和安全性;與全球已上市的同類藥相比,在動物血/腦暴露量方面具有優勢,對已有報道的多種臨牀耐藥突變有效,具有治療腫瘤腦轉移和克服臨牀耐藥突變的潛力。

截至目前,公司在KL590586膠囊項目上已投入研發費用約2955萬人民幣。

公司將按照家藥品監督管理局簽發的臨牀試驗通知書的要求,組織實施KL590586膠囊的臨牀試驗

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