On 4 July, China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) accepted the new drug application (NDA) for VC004, a next-generation TRK inhibitor developed by domestic company Vcare PharmaTech. Targeting NTRK fusion-positive solid tumours in adults and adolescents (≥12 years), VC004 is designed for patients with locally advanced/metastatic disease or those who failed prior therapies.

Compared to first-generation TRK inhibitors like Roche's entrectinib (currently the only approved TRK inhibitor in China), VC004 demonstrates superior efficacy and addresses acquired resistance mutations. Phase II trial data showed higher objective response rates (ORR) in both treatment-naive and pretreated patients, with improved safety (lower ≥Grade 3 treatment-related adverse events [TRAEs]). An Investigational New Drug (IND) application has also been approved in the US, positioning VC004 as a potential global leader in its class.