Hansoh Pharma Submits NDA for Fourth Indication of Aumolertinib in Unresectable Locally Advanced NSCLC

On August 19, Hansoh Pharma announced its self-developed Class 1 new drugAlmonertinib Mesylate TabletsNew indication marketing application accepted by China's National Medical Products Administration (NMPA) 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 TreatmentThis is the fourth indication marketing application submitted for Aumetinib Tablets in China.In this indication, Aumetinib tablets were just recently (August 9) included in the list of breakthrough therapies by the Center for Drug Evaluation (CDE) of the NMPA.

As a third-generation EGFR-TKI,Almonertinib TabletsWere approved in China in 2020 and 2021 respectively, for second-line treatment of patients with disease progression after prior EGFR-TKI therapy, andT790MPatients with mutation-positive locally advanced or metastatic NSCLC, and first-line treatment haveEGFRExon 19 deletion or exon 21 (L858R) Positive for substitution mutations in adult patients with locally advanced or metastatic NSCLC.In addition,Almonertinib TabletsThe third indication for marketing authorization was recently accepted by the CDE forWith EGFR exon 19 deletion or exon 21 (L858R) Positive substitution mutation in adult patients with NSCLCAdjuvant Therapy After Tumor Resection。

According to the introduction in the news release by Hansoh Pharma, this application for marketing authorization is based on the clinical trial data from the HS-10296-304 study. This is a randomized, controlled, double-blind phase 3 clinical study designed to evaluate the efficacy of Aumolertinib Mesylate compared to placebo in patients with unresectable locally advanced disease who have not experienced disease progression after platinum-based radical chemoradiotherapy.EGFRExon 19 deletion or exon 21 (L858R) in NSCLC patients with substitution mutations, the primary endpoint is 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.

References:

[1] Hansoh Pharma's Ameile® Fourth Indication Marketing Application Accepted. Retrieved Aug 19, 2024, from https://mp.weixin.qq.com/s/1J94-mtsKXFj8LuTnYC8sQ