China Approves Limertinib for Advanced Lung Cancer

China's National Medical Products Administration (NMPA) has approved limertinib, developed by Innovent Biologics and ASK Pharm, for treating adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). The approval is based on promising results from a pivotal phase 2b trial involving 301 patients, which showed an overall response rate of 68.8% and a disease control rate of 92.4%. Limertinib offers new hope for patients who have progressed after previous treatments with EGFR tyrosine kinase inhibitors (TKIs). In addition to this approval, Innovent is also pursuing further indications for the drug and has obtained Breakthrough Therapy Designation for another oncology treatment. The approval highlights Innovent's commitment to advancing oncology therapies in China and expanding its portfolio of innovative treatments. Limertinib is seen as a significant addition to Innovent's offerings, which now includes 14 products targeted at treating various cancers.