Hansoh Pharma's Ameile (Almonertinib) Receives NMPA Acceptance for New Adjuvant Therapy Indication in EGFR-Mutant NSCLC

On July 19, the New Drug Application (NDA) for a new indication of Almonertinib Mesylate Tablets (brand name: Alkeida), a Class 1 innovative drug independently developed by Hansoh Pharma, was accepted by the National Medical Products Administration (NMPA). It is intended for adjuvant treatment in adult patients with non-small cell lung cancer (NSCLC) who have tested positive for epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations following tumor resection.

The marketing application for this indication is based on the clinical trial data from the HS-10296-302 study. This is a randomized, controlled, double-blind, Phase III, multicenter clinical study led by Professor Cheng Ying from Jilin Cancer Hospital. The study aims to evaluate the efficacy and safety of Aumolertinib Mesylate compared with placebo as adjuvant therapy for patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who are positive for epidermal growth factor receptor (EGFR) sensitizing mutations. The primary endpoint is disease-free survival (DFS) assessed by an independent review committee, and secondary endpoints include DFS assessed by investigators, 2-year, 3-year, and 5-year DFS rates, overall survival (OS), 5-year OS rate, and safety.

Cancer epidemiology data released by the National Cancer Center shows that the number of new lung cancer cases in China reached 1.06 million in 2022, of which about 40% were NSCLC patients with EGFR mutations. Although 30% of EGFR-mutated NSCLC patients can be diagnosed early and undergo surgery, disease recurrence remains common among postoperative patients. Therefore, for patients with early- to mid-stage EGFR-mutated NSCLC, there is still a significant unmet need in current clinical practice.

This is the third indication marketing application submitted by Amelie in China. Previously, Amelie had twice made history as a domestically produced third-generation EGFR-TKI: In March 2020, Amelie was approved for patients with locally advanced or metastatic NSCLC who had progressed after prior EGFR-TKI treatment and were positive for the T790M mutation, becoming the first approved domestically produced third-generation EGFR-TKI in China; In December 2021, Amelie was approved for first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, making it the first domestically produced third-generation EGFR-TKI to gain approval for a first-line indication in China. Notably, both the first-line and second-line indications have been included in the National Reimbursement Drug List (NRDL). If this new indication receives marketing approval successfully, Amelie is expected to become the first domestically produced third-generation EGFR-TKI approved for adjuvant therapy post-surgery, providing a new option for adjuvant treatment in operable EGFR-positive NSCLC patients and helping more Chinese lung cancer patients benefit.