Jiangsu Vcare’s Next-Generation TRK Inhibitor VC004 IND Application was accepted by the US FDA

　　At the end of September 2024, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced that the US FDA has officially accepted the Investigational New Drug (IND) application of its independently developed new-generation anti-resistant TRK inhibitor VC004. This milestone paves the way for the global commercialization strategy.

　　Earlier this year in June, the Phase I clinical data of VC004 for tumors was impressively presented at ASCO 2024. The data showed superiority to first-generation drugs targeting in treating treatment-naive patients and exhibits significant curative effects in first-gen resistant patients. Moreover, the overall safety is good in all patients. Currently, VC004 is in the patient’s follow-up and pre-New Drug Application (NDA) preparation stage in China.

　　Clinically, VC004 is for treating patients with NTRK gene fusion-positive tumors and is not limited to specific cancer types. Compared with first-generation drugs targeting the same site, VC004 not only has stronger inhibitory activity against wild-type kinases but also features a unique anti-resistance mechanism, which is expected to extend the duration of clinical benefit for patients.

　　Currently, the first-generation drugs approved in the US are unable to solve the problem of secondary resistance in treatment-naive patients. Additionally, second-generation drugs demonstrate inferior efficacy in treatment-naive patients compared to first-generation drugs. Moreover, no second-generation drugs have been approved for marketing in China, leaving unmet clinical needs. In the future, the approval and launch of VC004 are expected to offer a potential optimal treatment option for treatment-naive and resistant patients in China, the US, and even globally.