By Fineline Cube 
China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Aoyixin (limertinib). The drug is now approved for use in first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations.
Approval Based on Phase III Study Results
The approval is supported by positive results from a randomized, double-blinded, positive-controlled Phase III study. The data demonstrated that limertinib significantly prolonged median progression-free survival (PFS) compared to gefitinib, with a PFS of 20.7 months versus 9.7 months. This represents a 56% risk reduction in disease progression or death.
Drug Background and Commercialization
Limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), was initially approved in China in January this year for treating locally advanced or metastatic EGFR T790M-mutated NSCLC. Innovent Biologics licensed the drug from Jiangsu Aosaikang Pharmaceutical Co. Ltd. (SHE: 002755) for commercialization in China through a deal concluded in October last year.-Fineline Info & Tech