Innovent Biologics Inc (HKEX:01801), a China-based biopharmaceutical company that develops, manufactures and commercialises medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announced on Friday that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR exon 19 deletions or exon 21 L858R mutations.

Innovent and ASK Pharm entered into a commercial collaboration agreement for limertinib in Mainland China in 2024.

This new indication was supported by positive results from a randomised, double-blind, positive-controlled Phase 3 clinical trial. A total of 337 treatment-naïve patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC were enrolled and randomised 1:1 to receive either limertinib or gefitinib. The primary endpoint was progression-free survival (PFS), as assessed by an independent review committee (IRC).

According to the company, the data showed that limertinib significantly prolonged median PFS compared to gefitinib. Limertinib's safety profile was consistent with that of known EGFR-targeted therapies. Full data and analysis from this pivotal Phase 3 study will be published in academic journals.