Jiangsu Vcare's New-generation TRK Inhibitor VC004 Obtains IND Approval from the US FDA

　　On October 16, 2024, Jiangsu Vcare Pharmatech Co., Ltd. (referred to as "Jiangsu Vcare")'s independently developed new-generation anti-resistant TRK inhibitor VC004 achieved a significant milestone, obtaining Investigational New Drug (IND) approval from the US FDA. This fully demonstrates Jiangsu Vcare's excellent drug research and development capabilities and successful execution of the company's strategies centered on original innovation, high-quality standards, and a global layout.

　　The TRK gene fusion plays a key role in various cancers and is one of the important driving factors for cancer occurrence and development. Clinically, VC004 is primarily used to treat patients with NTRK gene fusion-positive tumors and is not limited to specific cancer types. As a new-generation TRK inhibitor, VC004 has demonstrated excellent efficacy and safety in multiple previous clinical studies in China. It is currently in the subject follow-up and pre-New Drug Application (NDA) preparation stage.

　　VC004 not only shows a higher clinical response rate compared with first-generation drugs but also exhibits significant anti-resistance to first-generation drugs. The previous clinical data were impressively presented at the 2024 American Society of Clinical Oncology (ASCO 2024) annual meeting: among patients who have not been treated with TRK TKI previously, the confirmed objective response rate (ORR) in the recommended phase 2 dose (RP2D) expansion group is 73.1% [95% CI, 52.2-88.4]; among 3 patients who have progressed after being treated with TRK-TKIs previously, the tumors of 2 patients have shrunk, and 1 patients has achieved a partial response (PR) (39.6%); for the vast majority of patients after treatment with VC004, the drug takes effect quickly and they obtain long-term survival benefits, and the longest duration of continuous remission of patients has exceeded 36 months; among 6 patients with baseline brain metastases, the intracranial lesions of 2 patients have shrunk by 61.8% and 25% respectively, and the non-target lesions of another 2 patients have disappeared after 4 months of treatment. In terms of safety, most treatment-related adverse events (TRAEs) that patients experienced are grade 1-2, and no fatal TRAEs have occurred. Compared with other drugs of the same kind, no new safety signals have been found.