Pan-Cancer Potential! Jiangsu Vcare’s Anti-Resistant TRK Inhibitor VC004 Capsule advances to NDA Preparation Phase

　　In January 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced that its self-developed next-generation anti-resistant TRK inhibitor VC004 capsule has officially entered the domestic NDA preparation phase, initiating pre-NDA communications with regulatory authorities. Marking this milestone, Jiangsu Vcare has joined the top tier of domestic self-developed drugs targeting this pathway at remarkable speed.

　　VC004 is clinically indicated for the treatment of NTRK fusion-positive solid tumors. It features a "tumor-agnostic" mechanism and has demonstrated outstanding efficacy and favorable safety in Phase I/II clinical studies.

　　The Phase I data were presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024):

　　In treatment-naïve patients, the confirmed objective response rate (ORR) in the recommended Phase II dose (RP2D) expansion cohort was 73.1% [95% CI: 52.2–88.4]. Among three patients who had progressed on prior TRK-TKI therapy, two showed tumor shrinkage, with one achieving a partial response (PR, 39.6%).

　　Most patients experienced rapid onset and sustained clinical benefits, with the longest-to-date duration of response exceeding 36 months. Among six patients with baseline brain metastases, two exhibited intracranial lesion reductions of 61.8% and 25%, respectively, while two others showed complete disappearance of non-target lesions after four months of treatment.

　　Safety-wise, treatment-related adverse events (TRAEs) were predominantly Grade 1–2, with no fatal TRAEs reported. No new safety signals were observed compared to other drugs in the same class.

　　About VC004

　　VC004 is a Class 1 targeted anti-tumor drug, independently developed by Jiangsu Vcare. As a next-generation TRK inhibitor with a unique anti-resistance mechanism, it is poised to become a new treatment option for patients with NTRK fusion mutations. In China, the project is advancing with a single-arm Phase II trial as the pivotal study, while its Investigational New Drug (IND) application has been approved by the US FDA. Currently, no second-generation NTRK inhibitor matches the efficacy of first-generation drugs on NTRK-naïve patients and possesses second-generation anti-drug resistance activity, positioning VC004 as a front-runner in this category.