Aumolertinib Gains Fifth Indication in China: New First-Line Combination Therapy with Chemotherapy for EGFR-Mutant NSCLC

Jan 12, 2026 20:01 CST Updated 20:01

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Recently, Hansoh Pharma announced that its self-developed Ameitinib Mesylate Tablets have officially received the approval of the fifth indication from the China National Medical Products Administration (NMPA) —In combination with pemetrexed and platinum-based chemotherapy drugs for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.。

This approval not only marks the further expansion of Aumolertinib in the EGFR-mutated NSCLC treatment field but also brings a more promising "targeted therapy + chemotherapy" combination treatment option for patients in China.

China's Self-Developed Third-Generation EGFR-TKI Continues to Lead in Precision Treatment

Almonertinib Mesylate Tablets are the first domestically developed third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) in China, which was launched for the first time in March 2020. With good liposolubility and molecular stability, the drug can penetrate the blood-brain barrier more effectively, showing unique advantages in controlling intracranial lesions.

As a third-generation EGFR-TKI, Aumolertinib can efficiently and specifically inhibit the following three key types of mutations:

EGFR Exon 19 Deletion
Exon 21 L858R substitution mutation
T790M Resistance Mutation

By blocking the EGFR signaling pathway, it effectively inhibits the proliferation and metastasis of tumor cells. The newly added combination treatment regimen is based on its potent targeted action and the synergistic mechanism with chemotherapy drugs, further enhancing the depth and durability of treatment for EGFR-sensitive mutant NSCLC.

Comprehensive Coverage of Five Major Indications, More Patients Benefit from Medical Insurance

To date, Aumetinib has been approved for five indications, covering several key clinical scenarios from first-line treatment of advanced stages to postoperative adjuvant and maintenance therapy:

Previously treated with EGFR-TKI and progressed with T790M mutation-positive locally advanced or metastatic NSCLC;
First-line monotherapy for locally advanced or metastatic NSCLC with EGFR sensitizing mutations;
Maintenance treatment for unresectable locally advanced EGFR-sensitive mutant NSCLC without progression after platinum-based radical chemoradiotherapy;
Adjuvant treatment for stage Ⅱ–ⅢB EGFR-sensitive mutant NSCLC after surgery (with or without adjuvant chemotherapy);
Latest Approval: Combination of Pemetrexed + Platinum-based Chemotherapy for First-line Treatment of EGFR Mutation-positive Advanced NSCLC.

Notably, the first four indications have been included in the national medical insurance catalog, significantly reducing the financial burden on patients and improving the accessibility of innovative drugs.

AENEAS 2 Study: Combination Regimen Significantly Extends Progression-Free Survival

The approval of this new indication is based on the pivotal Phase III clinical study——AENEAS 2. The study was specifically designed for Chinese patients with EGFR-sensitive mutant NSCLC. The results were重磅 released in an oral plenary session at the 2025 American Association for Cancer Research (AACR) Annual Meeting, drawing widespread attention.

Research data shows:

Median Progression-Free Survival (PFS) Reached 28.9 Months, significantly superior to the single-agent arm of amivantamib;
53% reduction in risk of disease progression or death(Hazard Ratio HR=0.47);
Objective Response Rate (ORR) as high as 93.2%, far exceeding the level of single-drug treatment.

These data fully demonstrate that the combination strategy of "Almonertinib + chemotherapy" can not only shrink tumors more quickly but also control disease progression more durably, allowing patients to gain a longer period of high-quality survival.

Good safety profile, no new risks identified.

In the AENEAS 2 study, the overall safety of Aumolertinib combined with chemotherapy was controllable.No new safety signals were observed.. This provides a solid safety guarantee for clinicians when formulating individualized treatment plans.

Conclusion: Precise Combination, Towards Better Survival

With the approval of the fifth indication, Aumetinib Mesylate Tablets have become an important therapeutic weapon for the comprehensive management of EGFR-mutant NSCLC throughout the entire course of the disease. The approval of this "targeted therapy + chemotherapy" combination not only expands treatment options for patients in China but also highlights the rising strength of China's indigenous innovative drugs in the global landscape of precision lung cancer treatment.

In the future, with the accumulation of more real-world data and the deepening of clinical applications, Aumetinib is expected to continue rewriting the treatment standards for EGFR-mutated NSCLC, helping more patients achieve both long-term survival and improved quality of life.

Reference Source:

1. NMPA Official Website

2.Pharmaceutical Company Official Website

Disclaimer: This article aims to promote communication and exchange in pharmaceutical academia and is intended for healthcare professionals only. MedSci Medicine does not recommend any drugs and/or indications. The drug information involved in this article is for reference only and cannot replace professional medical guidance in any way, nor should it be regarded as diagnostic or therapeutic advice. If you want to know specific disease diagnosis and treatment information, please follow the advice or guidance of hospital doctors.