Hansoh Pharma Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced the fifth New Drug Application (“NDA”) of the Group’s innovative drug Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) has been accepted by the National Medical Products Administration of China (“NMPA”). The indication is that Ameile in combination with pemetrexed and platinum-based chemotherapy is used as the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) whose tumors have epidermal growth factor receptor (“EGFR”) exon 19 deletions or exon 21 (L858R) mutations.
This marketing application is based on a phase III registered clinical trial called AENEAS2. Based on blinded independent central review, data from AENEAS2 phase III demonstrate a statistically significant risk reduction over 50% in disease progression or death in patients with the combination of AMEILE and chemotherapy in comparison to AMEILE monotherapy. The median progression-free survival of AMEILE and chemotherapy combination has been extended to over 2 years. Safety results were consistent with the established profiles of each medicine that observed in previously reported studies. No new safety signals were identified.
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 third 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. In August 2024, the fourth NDA of Ameile 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.
Lung cancer has the highest incidence and mortality rates in China, 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 them. With the further expansion of indications for the treatment of lung cancer by Ameile, Hansen Pharma is expected to provide more treatment options for lung cancer patients in China.
About the AENEAS2 Trial
AENEAS2 is a randomized, open-label, multi-center, Phase III trial in the first line treatment of 624 patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with AMEILE ® (aumolertinib 110 mg) once daily oral tablets in combination with chemotherapy (pemetrexed 5 00mg/m2plus cisplatin 75mg/m2 or carboplatin (AUC5)) every three weeks for four cycles, followed by AMEILE with pemetrexed maintenance every three weeks.
About Lung cancer
Lung cancer remains the leading cause of both cancer incidence and mortality in China. According to statistics from 2022, approximately 1.06 million new lung cancer cases were reported in China, accounting for 22.0% of all malignancies, with 740,000 cancer-related deaths, representing 28.5% of all cancer fatalities. 1 Among these cases, non-small cell lung cancer (NSCLC) is the most prevalent type, constituting 85% of all diagnoses.2 Patients with EGFR mutations are particularly responsive to EGFR-TKIs, a class of targeted therapies that block specific signaling pathways that promote tumor growth.3
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. https://doi.org/10.1016/j.jtho.2020.01.008
2.Wang, X., & Li, Y. (2021). Non-small cell lung cancer: Advances in diagnosis and treatment. Chinese Medical Journal, 134(10), 1234-1242. https://doi.org/10.1097/CM9.0000000000001511
3.Zhang, L., Sun, Y., & Li, Q. (2022). Lung cancer statistics in China: Incidence and mortality. Cancer Research, 82(12), 2303-2310. https://doi.org/10.1158/0008-5472.CAN-22-0453
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