Core Viewpoint - The company, Innovent Biologics, has received approval from the National Medical Products Administration (NMPA) for its self-developed next-generation TRK inhibitor, Zolbetuximab (ICP-723), making it the first domestically developed next-generation TRK inhibitor approved for marketing in China [1] Group 1 - The new drug is indicated for the treatment of adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] - In key registration clinical trials for patients with NTRK fusion-positive solid tumors, Zolbetuximab demonstrated excellent efficacy and safety as a broad-spectrum anti-cancer drug [1] Group 2 - The registration clinical study results showed an overall response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4% [1] - The 24-month progression-free survival (PFS) rate was 77.4%, and the 24-month overall survival (OS) rate was 90.8% [1]
诺诚健华(688428.SH):佐来曲替尼(ICP-723)在中国上市申请获批准