On March 10, 2025,Hansoh Pharma 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.
About Hansoh Pharma
Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. To date, Hansoh Pharma has launched 7 innovative drugs to form a diverse commercial portfolio. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June 2019 (stock code: 03692.HK). For more information, please visitwww.hspharm.com.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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References
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Post time: Mar-14-2025