On August 19, 2024, Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma," 03692.HK) announced that the new drug application ("NDA") for a new indication of Ameile (Aumolertinib Mesilate Tablets) has been accepted by the National Medical Products Administration ("NMPA") for the treatment in patients with locally advanced, unresectable, epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 (L858R) substitute mutations, non-small cell lung cancer ("NSCLC") without progression following definitive platinum-based chemoradiotherapy. This is the fourth indication marketing application for Ameile submitted in China. This indication of Ameile was included in the NMPA's list of breakthrough therapies on August 9, 2024.

This marketing application for the new indication is based on clinical trial data from the HS-10296-304 study. It is a randomized, controlled, double-blind Phase III clinical study aimed at evaluating the efficacy and safety of Aumolertinib Mesilate compared to the placebo in treating patients with unresectable, locally advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitute mutations, who have not experienced disease progression following platinum-based chemoradiotherapy. The primary endpoint of the study is progression-free survival ("PFS") as assessed by an independent review committee. The secondary endpoints include overall survival ("OS"), time to central nervous system ("CNS") progression as assessed by an independent review committee, time to death or distant metastasis ("TTDM"), objective response rate ("ORR"), disease control rate ("DCR"), duration of response ("DoR"), and safety.

Ameile is the first innovative third-generation EGFR-TKI drug wholly developed in China. In March 2020, Ameile obtained approval for the treatment of patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy. In December 2021, Ameile obtained approval to be used as the first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitute mutation positive; and the drug's first- and second-line indications have been included in the National Reimbursement Drug List ("NRDL"). In July 2024, the NDA of Ameile for adjuvant therapy after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations was accepted by the NMPA.

Lung cancer has the highest incidence and mortality rates in China. According to statistics released by the National Cancer Center⁽¹⁾, there were 1.0606 million  new cases of lung cancer and 733,300 deaths in China in 2022, highlighting a significant unmet clinical need. Hansoh Pharma has long been dedicated to improving the treatment of lung cancer patients and continues to explore new treatment regimens for patients in China and globally.

(1) https://www.sciencedirect.com/science/article/pii/S2667005424000061