On January 16, 2025, Aoyixin® (Liertinib Tablets, Investigational Code:
ASK120067), a Class 1 chemical new drug and third-generation EGFR inhibitor, was
approved for marketing by the National Medical Products Administration (NMPA).
It is indicated for the treatment of adult patients with EGFR T790M
mutation-positive locally advanced or metastatic non-small cell lung cancer
(NSCLC) who have experienced disease progression during or after prior treatment
with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
(TKI).
This drug is co-developed by the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, the Guangzhou Institutes of Biomedicine and Health of the Chinese Academy of Sciences, and Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Lung cancer is one of the malignancies with the highest incidence and mortality rates worldwide, among which NSCLC accounts for approximately 85% of all lung cancer cases. Around 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is inoperable for surgical resection. EGFR is the most common driver gene in NSCLC, with 30% to 50% of Asian NSCLC patients harboring EGFR gene mutations. EGFR-TKIs are recommended as the first-line standard treatment for this patient population, and third-generation EGFR-TKIs cover a broad spectrum of eligible patients.
Liertinib Tablets is an oral third-generation EGFR TKI with independent intellectual property rights, novel molecular entity, and potent activity. It selectively inhibits the EGFR T790M mutation. Preclinical studies have shown that it can significantly suppress the growth of lung cancer with EGFR mutations.
The main adverse reactions of liertinib are consistent with the previously reported profiles of EGFR TKIs of the same class, and the drug is well-tolerated. The approval and launch of liertinib provides a new therapeutic option for lung cancer patients.
