Hansoh Pharmaceutical receives NMPA approval for third indication of Ameile

Hansoh Pharmaceutical Group has received drug registration approval from the National Medical Products Administration (NMPA) for its third indication of Ameile. The Company is primarily engaged in the research, development, production, and sale of pharmaceutical products, including Ameile, Hansoh Xinfu, Mailingda, Fulaimei, and Hengmu.

Hansoh Pharmaceutical Group (Hansoh Pharma, 03692.HK) announced on [NUMBER:1] that the National Medical Products Administration of China (NMPA) has approved the third indication of its innovative drug Ameile (阿美乐®) 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. This approval marks the third indication for Ameile since its commercial launch five years ago and makes it 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 results of the POLESTAR study (HS-10296-304), a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial that evaluated the effects of Ameile as maintenance therapy in unresectable stage III NSCLC following chemoradiotherapy. The study was led by Academician Prof. Yu Jinming from Shandong Cancer Hospital as the principal investigator.

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. Furthermore, the benefit of Ameile over placebo for PFS was consistent across all predefined subgroups, indicating a comprehensive benefit profile.

In addition to the significant improvement in PFS, 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 was also lower.

The overall tolerability and manageability of Ameile in patients after chemoradiotherapy were favorable. The incidence of ≥3 grade radiation pneumonitis was 0, and the incidence of interstitial pneumonia was also 0.

With three indications approved for market authorization, Hansoh Pharma's Ameile is poised to continue its impact on the treatment of NSCLC in China.