On July 19, 2024, Hansoh Pharma's New Drug Application (NDA) for Ameile (almonertinib mesylate tablets), an independently-developed class 1 new drug, was accepted by the National Medical Products Administration (NMPA) for adjuvant treatment of mutation-positive non-small cell lung cancer (NSCLC) in adult patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution after tumor resection.

The marketing authorization application for this indication is based on research data from the HS-10296-302 clinical trial. The study was a randomized, controlled, double-blind, Phase III, multicenter clinical study led by Professor Cheng Ying of Jilin Provincial Cancer Hospital to evaluate the efficacy and safety of almonertinib mesylate tablets versus placebo for the adjuvant treatment of epidermal growth factor receptor (EGFR) mutation-positive stage II-IIIB NSCLC. The primary endpoint of the study was progression-free survival (PFS), as assessed by an independent review committee, and secondary endpoints included investigator-assessed DFS, two-, three-, and five-year DFS rates, overall survival (OS), five-year OS rate, and safety.

According to data on cancer epidemiology released by the National Cancer Center, China's new cases of lung cancer in 2022 reached 1.06 million, of which about 40% were NSCLC patients with EGFR mutations. Although 30% of NSCLC patients with EGFR mutations can be diagnosed at an early stage and receive surgery, disease recurrence is common in the postoperative patient population. Therefore, a substantial unmet clinical need still exists for patients with early to mid-stage NSCLC with EGFR mutations.

This is the third indication where Ameile has been submitted for marketing in China. As China's third-generation EGFR-TKI, Ameile has made history twice previously: In March 2020, Ameile was approved for use in patients with T790M mutation-positive locally advanced or metastatic NSCLC which had progressed after previous EGFR-TKI therapy, making it the first domestically developed third-generation EGFR-TKI approved for marketing; and in December 2021, Ameile was approved as the first-line treatment for adult patients with locally advanced or metastatic mutation-positive NSCLC with positive EGFR exon 19 deletion or exon 21 (L858R) substitution, becoming the first domestically developed third-generation EGFR-TKI approved for first-line treatment. It is worth mentioning that the drug's first- and second-line indications have been included in the National Reimbursement Drug List (NRDL). If the marketing application for this new indication is approved, Ameile will become the first domestic third-generation EGFR-TKI approved for post-operative adjuvant treatment, providing a new option for operable EGFR-positive NSCLC patients which more Chinese lung cancer patients can benefit from.