Hansoh Pharma Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced the third New Drug Application (“NDA”) of the Group’s innovative drug Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) has been approved by the National Medical Products Administration of China (“NMPA”) for the treatment of patients with locally advanced, unresectable（Stage III）non-small cell lung cancer ("NSCLC") whose disease has not progressed following definitive platinum-based chemoradiotherapy whose tumors have epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 (L858R) substitute mutations. This is the third indication approved for Ameile since its commercial launch five years ago. As a result, Ameile has become the only domestically developed third-generation EGFR-TKI approved for maintenance therapy in patients with unresectable stage III NSCLC following chemoradiotherapy.
The approval was primarily based on the POLESTAR study (HS-10296-304), a randomized, double-blind,placebo controlled, multicenter phase III clinical trial to evaluate the effects of Ameile as maintenance therapy in unresectable stage III NSCLC following chemoradiotherapy. The POLESTAR study was led by Academician Prof. Yu Jinming from Shandong Cancer Hospital as the principal investigator. The results were selected for the 2024 World Conference on Lung Cancer (WCLC) "Late Breaking Abstract (LBA)" list and presented at the President's Symposium of the conference.
The study results showed that Ameile reduced the risk of disease progression by more than 80% and the median progression-free survival (mPFS) for patients treated with Ameile was 30.4 months compared with just 3.8 months for those receiving placebo. Additionally, the benefit of Ameile over placebo for PFS were consistent across all predefined subgroups, indicating a comprehensive benefit profile. Furthermore, the objective response rate (ORR) in the Ameile treatment group assessed by BICR reached 57%, with the median duration of response (DoR) extending to 16.59 months and median overall survival (OS) not yet reached. The incidence of CNS lesions and distant metastases were lower. The overall tolerability and manageability of Ameile in patients after chemoradiotherapy were favorable. In terms of adverse events (AEs), the incidence of≥3 grade radiation pneumonitis was 0, and the incidence of interstitial pneumonia was also 0.
So far, Ameile has three indications approved for market authorization, and the first two indications were listed in the 2024 version of the National Reimbursement Drug List (NRDL) in November 2024. Additionally, two new drug applications (sNDA) for additional indications have been accepted and currently under review.
Indication 1: Second-Line Treatment
Patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy
Approval Date: March 2020
Indication 2: First-Line Treatment
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
Approval Date: December 2021
NDA Accepted: Adjuvant Therapy Post-Surgery
Adjuvant therapy after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations
Acceptance Date: July 2024
NDA Accepted: Targeted and Chemotherapy Combination
In combination with pemetrexed and platinum-based chemotherapy to be used as the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations
Acceptance Date: November 2024
About Lung Cancer
Lung cancer remains the biggest cause of cancer incidence and mortality in China. According to statistics from 2022, there were approximately 1.06 million new lung cancer cases in China, accounting for 22.0% of all malignant tumors, with 740,000 cancer-related deaths, representing 28.5% of all cancer deaths[1]. Among these, non-small cell lung cancer (NSCLC) is the most common type, comprising 85% of diagnoses[2]. Patients with EGFR mutations are particularly sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), a class of targeted therapies that block specific signaling pathways promoting tumor growth[3].
About Ameile
As China's first original third-generation EGFR-TKI, Ameile (Aumolertinib Mesilate Tablets) innovatively incorporates a cyclopropyl structure with good liposolubility and stability, allowing it to better penetrate the blood-brain barrier with a low incidence of adverse reactions. Currently, Ameile has been approved for three indications: second-line treatment of patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy; 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; treatment of patients with locally advanced, unresectable（Stage III）non-small cell lung cancer ("NSCLC") whose disease has not progressed following definitive platinum-based chemoradiotherapy whose tumors have epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 (L858R) substitute mutations.
Reference
[1] Liu, Y., Chen, H., & Zhou, Q. (2020). Targeted therapies for EGFR-mutant lung cancer: Advances and challenges. Journal of Thoracic Oncology, 15(5), 743-755.
[2] Wang, X., & Li, Y. (2021). Non-small cell lung cancer: Advances in diagnosis and treatment. Chinese Medical Journal, 134(10), 1234-1242.
[3] Zhang, L., Sun, Y., & Li, Q. (2022). Lung cancer statistics in China: Incidence and mortality. Cancer Research, 82(12), 2303-2310.
