Jiangsu Vcare's Next-Generation TRK Inhibitor VC004 Enters Pivotal Phase II Trial

　　Recently, the initiation of the pivotal Phase II trial for Jiangsu Vcare Pharmaceutical Technology Co., Ltd.'s (Jiangsu Vcare) next-generation TRK inhibitor VC004 project was announced at its first center, the Cancer Hospital Chinese Academy of Medical Sciences. Subsequent recruitment will take place across nearly 30 clinical centers nationwide. This pivotal single-arm Phase II trial, based on positive results from the previous Ib phase and a design agreed upon with the NMPA, will continue enrolling the target patient population at the RP2D level to collect safety and efficacy data for VC004.

　　About VC004

　　VC004 is a Class I targeted anti-tumor innovative drug independently developed by Jiangsu Vcare. As a next-generation TRK inhibitor, it is expected to provide a treatment option for patients with NTRK fusion mutations while addressing the unmet clinical need for overcoming resistance to first-generation inhibitors. As a next-generation therapeutic, VC004 demonstrates excellent clinical efficacy and safety. Currently, no next-generation resistance-overcoming drugs are marketed globally. VC004 has the potential to become a leading next-generation TRK inhibitor worldwide.

　　About NTRK Fusion-Positive Solid Tumors

　　NTRK gene fusions have been identified as oncogenic drivers in both adult and pediatric patients with a wide range of solid tumors. The NTRK genes (NTRK1, NTRK2, and NTRK3) encode the TRKA, TRKB, and TRKC receptors of the TRK family. These fusions act as drivers in multiple cancers and are found across numerous solid tumor types. Currently, NTRK fusion inhibitors show remarkable efficacy in the clinical practice, holding immense potential in the field of oncology. In China, NTRK gene fusion mutations are found in prevalent cancer types such as lung cancer, colorectal cancer, breast cancer, and thyroid cancer, especially high prevalence in certain rare cancers, including secretory breast carcinoma and salivary gland secretory carcinoma.