Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) and pharmaceutical company Jiangsu Aosaikang Pharmaceutical Co Ltd (ASK Pharm) (SZ:002755) announced on Thursday that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC).

Limertinib is the 14th product in Innovent's commercial portfolio and represents an addition to its TKI franchise, offering an innovative precision therapy option to lung cancer patients.

A Phase 2b pivotal study evaluating 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC demonstrated limertinib's efficacy and safety profile. Independent review committee (IRC) assessment showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%. The median progression-free survival (PFS) reached 11.0 months, with a median duration of response (DoR) of 11.1 months. For patients with assessable central nervous system (CNS) lesions, the CNS best-ORR was 65.9% with a median PFS of 10.6 months. The safety profile aligned with other EGFR-targeting agents in its class.

Additionally, limertinib met the primary endpoint in a Phase 3 clinical trial comparing it to gefitinib for first-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations. A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review.