诺诚健华佐来曲替尼上市申请获批

Core Viewpoint - The company announced that its self-developed next-generation TRK inhibitor, Zolacritinib (Yinoxin, ICP-723), has been approved for market by the National Medical Products Administration, marking it as China's first self-developed next-generation TRK inhibitor approved for sale [1] Group 1: Product Approval - Zolacritinib is approved for the treatment of adult and adolescent patients aged 12 and older with solid tumors carrying NTRK fusion genes [1] - This approval highlights the company's capability in developing innovative cancer therapies within the Chinese market [1] Group 2: Clinical Trial Results - In key registration clinical trials for patients with NTRK fusion-positive solid tumors, Zolacritinib demonstrated a total response rate (ORR) of 89.1% [1] - The disease control rate (DCR) was reported at 96.4% [1] - The 24-month progression-free survival (PFS) rate was 77.4%, and the overall survival (OS) rate at 24 months was 90.8% [1]