Hansoh Pharma's Novel Lung Cancer Drug Aumolertinib Approved for New Adjuvant Therapy Indication in China

Today (May 9),The official website of China's National Medical Products Administration (NMPA) has just released approval information showing that Hansoh PharmaThe new indication application for the third-generation EGFR-TKI, Aumetinib Mesylate Tablets, has been approved.According to the previous press release by Hansoh Pharma, the indications approved for this drug are:For those with epidermal growth factor receptor (EGFR) Exon 19 deletion or exon 21 (L858R) Positive substitution mutation in adult patients with non-small cell lung cancer (NSCLC) for adjuvant treatment after tumor resectionThis is also the fourth indication for Aumetinib to be approved in China.

Screenshot source: NMPA Official Website

According to a previous press release from Hansoh Pharma,AlmonertinibThis marketing application is based onHS-10296-302 StudyClinical trial data. This was a randomized, controlled, double-blind, Phase 3, multicenter clinical study designed to evaluate the efficacy of Aumolertinib Mesylate versus placebo inEGFRAdjuvant Treatment for Sensitive Mutation-Positive Stage II-IIIb Non-Small Cell Lung CancerThe efficacy and safety, with the primary endpoint being the disease-free survival (DFS) assessed by an independent review committee, and secondary endpoints including DFS assessed by investigators, 2-year, 3-year, and 5-year DFS rates, overall survival (OS), 5-year OS rate, and safety, among others.

At the 2025 AACR Annual Meeting, data from the ARTS study (HS-10296-302 study) was presented in an oral report at a symposium. The data confirmed the efficacy for completely resected stage Ⅱ-ⅢB patients carryingEGFRNSCLC patients with mutations receiving Ametinib tablets as adjuvant therapy, where applicable,Can significantly improve patients' disease-free survival (DFS).

Specifically, a total of 214 Chinese patients completed randomization (107 in the Aumolertinib group and 107 in the placebo group). The baseline characteristics were balanced between the two groups (Aumolertinib group/Placebo group): females 55%/57%, stage II 45%/45%, stage III 55%/53%, exon 19 deletion 48%/51%.L858RMutation 52%/49%. The median follow-up time assessed by BICR was 27.6 months. The median DFS in the Aumolertinib group was not reached, while in the placebo group it was 19.4 months.The DFS results assessed by the researchers were consistent with the BICR assessment, with a 2-year DFS rate of 90.2% in the amethopterin group, significantly better than the 44.4% in the placebo group.

In addition to the aforementioned approved indications, the fifth marketing application for Aumetinib is currently under review, namelyIn combination with pemetrexed and platinum-based chemotherapy drugs, it is suitable for patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) First-line treatment for adult patients with locally advanced or metastatic NSCLC harboring substitution mutations. The marketing application for this indication was accepted by the CDE in November 2024.

References:

[1] Drug Approval Certificate Delivery Information on May 9, 2025. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250509152738101.html

[2] Hansoh Pharma's Ameile® Lung Cancer Adjuvant Treatment Indication Marketing Application Successfully Accepted. Retrieved July 19, 2024, from https://mp.weixin.qq.com/s/1C7x4HKQ_KBUQPgFhCgY5w

[3] AACR 2025 Preview | Hansoh Pharma's Almonertinib Two Phase III Studies Selected for Oral Presentation, Showcasing China's R&D Strength Again. Retrieved Mar 26，2025, From https://mp.weixin.qq.com/s/O2CTFCsyqpQk9W4qOpO7ag

[4] AACR 2025 Oral Presentation | Hansoh Pharma's Ameile® Phase III Data for Adjuvant Treatment of Non-Small Cell Lung Cancer Post-Surgery Globally Released for the First Time, with 2-Year Disease-Free Survival Rate Reaching 90.2%. Retrieved Apr 29，2025, From https://mp.weixin.qq.com/s/wU6T-E9ERXFMglDKU80aYQ