Novartis Expands Indications for Iptacopan, Capmatinib in China

Novartis has secured Chinese approval for iptacopan in immunoglobulin A (IgA) nephropathy following positive Phase III APPLAUSE-IgAN trial results showing 38.3% proteinuria reduction versus placebo in patients with rapid disease progression risk. The oral complement factor B inhibitor previously gained approvals for paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy (C3G) in China, representing Novartis' third renal disease indication approval in 2025. The first-in-class therapy acts upstream of C5 inhibitors to control both intravascular and extravascular haemolysis with convenient twice-daily dosing. Simultaneously, Novartis received approval for MET inhibitor capmatinib in previously treated MET exon 14 skipping non-small cell lung cancer (NSCLC), expanding beyond its 2024 first-line approval. Capmatinib demonstrates high oral bioavailability and selective MET tyrosine kinase inhibition (TKI) to block downstream signalling pathways driving tumour proliferation and migration. Lung cancer remains China's leading cause of cancer mortality with 1.06 million new cases annually, where MET alterations represent key oncogenic drivers in approximately 3% to 4% of NSCLC patients.

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