Xuanzhu Biopharma, a subsidiary of China's Sihuan Pharmaceutical, has secured Chinese approval for its next-generation ALK inhibitor XZP-3621 in treatment-naive ALK-positive non-small cell lung cancer (NSCLC). The oral therapy demonstrated superior response rates and safety compared to existing ALK inhibitors in clinical trials, with additional activity against resistance mutations and effective blood-brain barrier (BBB) penetration for treating brain metastases.

XZP-3621's approval addresses a growing Chinese ALK inhibitor market projected to reach RMB 7 billion by 2030, serving approximately 3% to 7% of NSCLC patients with ALK rearrangements. The drug's improved safety profile and activity against common resistance mutations position it as a preferred first-line option for this patient population, where five-year survival rates exceed 60% with targeted therapies.

PharmCube's NextBiopharm® database lists 12 ALK-targeting drugs approved in China, developed by 18 companies. Click here to request a free trial for NextBiopharm®.