Core Viewpoint - Innovent Biologics and Jiangsu Aosaikang Pharmaceutical have received approval from China's National Medical Products Administration for limertinib, a new treatment for adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) [1][4][5] Group 1: Product Approval and Clinical Efficacy - Limertinib is the 14th product in Innovent's commercial portfolio, enhancing its TKI franchise and providing a precision therapy option for lung cancer patients [1][5] - A Phase 2b pivotal study involving 301 patients showed limertinib's overall response rate (ORR) at 68.8% and a disease control rate (DCR) of 92.4%, with a median progression-free survival (PFS) of 11.0 months [2][4] - The drug also met its primary endpoint in a Phase 3 trial comparing it to gefitinib for first-line treatment of NSCLC with EGFR mutations [3][8] Group 2: Future Prospects and Strategic Collaborations - A second NDA for limertinib is under review for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations [3][7] - The collaboration between Innovent and ASK Pharm aims to bring limertinib to market, with expectations of benefiting more patients in the near future [5][9] - ASK Pharm is also developing ASKC202, a new c-Met inhibitor, in combination with limertinib to address third-generation EGFR-TKI resistance [5][12] Group 3: Industry Context and Market Potential - Lung cancer is one of the deadliest cancers globally, with NSCLC accounting for approximately 85% of cases, and EGFR mutations are prevalent in 30% to 50% of Asian NSCLC patients [6][10] - EGFR-TKIs are the recommended first-line treatment for this patient group, indicating a significant market opportunity for limertinib [6][10]
Innovent and ASK Pharm Jointly Announce NMPA Approval of Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer