Hansoh Pharma's Lung Cancer Drug Aumolertinib Granted New Indication for Unresectable Locally Advanced NSCLC
Hansoh Pharma
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▎WuXi AppTec Content Team Report
Today (March 10), the official website of China's National Medical Products Administration (NMPA) announced that Hansoh PharmaThe new indication for the third-generation EGFR-TKI, Aumetinib Mesylate Tablets, has been approved for marketing. According to publicly available data, the indication approved this time is:Used forUnresectable locally advanced epidermal growth factor receptor (EGFR) Exon 19 deletion or exon 21 (L858R) Substitution Mutation in Non-Small Cell Lung Cancer (NSCLC) Patients Treatment. In this indication, Aumetinib tablets have previously been included in the breakthrough therapy category and priority review by the Center for Drug Evaluation (CDE) of the NMPA.
Screenshot source:NMPA Official Website
As a third-generation EGFR-TKI,Almonertinib TabletsWere approved in China in 2020 and 2021, respectively, for use inSecond-line treatment for patients who have previously progressed after EGFR-TKI treatment, andT790MPatients with mutation-positive locally advanced or metastatic NSCLC, andFirst-line treatment hasEGFRExon 19 deletion or exon 21 (L858R) Adult patients with locally advanced or metastatic NSCLC who are positive for substitution mutations。
According to the previous press release from Hansoh Pharma, the marketing application for the approved indication is based onHS-10296-304 StudyClinical trial data. This is a randomized, controlled, double-blind Phase 3 clinical study designed to evaluate the efficacy of Aumetinib Mesylate versus placebo forUnresectable locally advanced disease without progression after platinum-based radical chemoradiotherapyEGFRExon 19 deletion or exon 21 (L858R) Substitution Mutation in NSCLCThe efficacy and safety of patient treatment, with the primary endpoint being progression-free survival (PFS) assessed by an independent review committee; secondary endpoints include overall survival (OS), time to central nervous system (CNS) progression, time to death or distant metastasis (TTDM), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and safety, among others, as evaluated by the independent review committee.
References:
[1] March 10, 2025 Drug Approval Certificate Delivery Information. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250310135234153.html
[2] Hansoh Pharma's Ameile® Fourth Indication Marketing Application Accepted. Retrieved Aug 19, 2024, from https://mp.weixin.qq.com/s/1J94-mtsKXFj8LuTnYC8sQ
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