Zheng Quan Shi Bao Wang·2026-01-09 02:05Core Viewpoint - The approval and clinical application of the new generation TRK inhibitor, Zolacotrine (Yinoxin, ICP-723), marks a significant breakthrough in China's broad-spectrum anti-cancer drug development, providing better treatment options for patients with NTRK fusion-positive solid tumors [1][3]. Group 1: Drug Development and Approval - Zolacotrine is the first domestically developed TRK inhibitor approved for clinical use in China, with prescriptions already issued in multiple hospitals [1][3]. - The drug addresses unmet clinical needs for patients with NTRK fusion-positive tumors, which are prevalent in over 26 types of solid tumors [4]. Group 2: Clinical Efficacy - Clinical studies show Zolacotrine has a total response rate (ORR) of 89.1%, with a disease control rate (DCR) of 96.4%, and a 24-month progression-free survival rate (PFS) of 77.4% [5]. - The drug demonstrates a total survival rate (OS) of 90.8%, indicating its potential to provide long-term relief for patients [5]. Group 3: Safety and Administration - Zolacotrine has a low rate of treatment-related adverse events leading to permanent discontinuation, at only 0.4%, enhancing patient compliance [7]. - The once-daily oral administration of Zolacotrine offers convenience for long-term treatment [7]. Group 4: Overcoming Resistance - Zolacotrine effectively overcomes resistance issues associated with first-generation TRK inhibitors, maintaining strong inhibitory activity against common mutations in the TRK kinase domain [9]. Group 5: CNS Penetration - The drug's unique molecular structure allows it to effectively penetrate the blood-brain barrier, achieving a 100% objective response rate in intracranial lesions, thus providing comprehensive protection for patients with brain metastases [10]. Group 6: Company Perspective - The CEO of the company expressed gratitude towards regulatory bodies, clinical experts, and partners for their support in the development and launch of Zolacotrine, emphasizing its role in improving the quality of life for cancer patients [12].