君實生物(01877.HK):EGFR exon 20插入等非常見突變抑制劑JS111獲得藥物臨牀試驗批准通知書
格隆匯4月26日丨君實生物(01877.HK)發佈公吿,公司與微境生物醫藥科技(上海)有限公司共同投資的蘇州君境生物醫藥科技有限公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,EGFR非常見突變抑制劑AP-L1898膠囊(項目代號JS111)的臨牀試驗申請獲得批准。
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年2月20日受理的AP-L1898膠囊符合藥品註冊的有關要求,同意開展晚期非小細胞肺癌的臨牀試驗。
JS111是一種有效抑制EGFR(表皮生長因子受體)非常見突變的靶向小分子抑制劑。EGFR非常見突變佔所有EGFR突變的比例約為10%,包括EGFR exon 20插入、T790M原發點突變和複合突變以及以G719X為代表的位於外顯子18-21之間的其他點突變和序列重複突變。現有的EGFR-TKI、化療和免疫療法對於攜帶EGFR exon 20插入等EGFR非常見突變的非小細胞肺癌患者臨牀獲益有限,患者具有迫切的臨牀治療需求。臨牀前數據顯示,JS111保持了抑制T790M等EGFR常見變異的活性和對野生型EGFR的選擇性,但同時克服了第三代EGFR抑制劑對exon 20插入等EGFR非常見突變的不敏感。JS111的開發有望給攜帶EGFR exon20插入突變等EGFR非常見突變的腫瘤患者帶來新的治療方式。公司擁有JS111在全球範圍內的獨家生產權、委託生產權及銷售權。
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