China greenlight for Innovent and ASK Pharm’s limertinib

China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), from Innovent Biologics (HK: 01801) and Aosaikang Pharmaceuticals (ASK Pharm, SZ: 002755).

Limertinib is the 14th product in Innovent's commercial portfolio and represents a cutting-edge addition to its strong TKI franchise, offering an innovative precision therapy option to lung cancer patients. In October last year, Innovent signed a deal with ASK Pharma for the commercialization of the drug in mainland China.

The companies noted that the Phase IIb pivotal study supporting the application evaluated 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC and demonstrated limertinib's robust 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 (N=99), 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.