Jiangsu Vcare's Next-Generation TRK Inhibitor VC004 Project Approved for Pivotal Phase II Clinical Trial

　　Recently, the pivotal Phase II clinical study for Jiangsu Vcare Pharmaceutical Technology Co., Ltd.'s (Jiangsu Vcare) next-generation TRK inhibitor VC004 for treating NTRK fusion-positive solid tumors was approved by the NMPA. This clinical study will further evaluate the efficacy and safety of VC004 in patients with NTRK fusion mutations. Upon success, Jiangsu Vcare plans to submit an NDA in China.

　　VC004 is a next-generation TRK inhibitor independently developed by Jiangsu Vcare for the clinical treatment of solid tumors with NTRK fusion mutations. Phase I clinical data show an ORR of 80-90% in patients with NTRK fusion-positive solid tumors, with the longest DOR reaching 24 months. Efficacy data collection is ongoing. Preliminary efficacy was also observed in patients with brain metastases and those previously treated with TRK inhibitors, with over 60% of brain metastasis patients showing varying degrees of tumor shrinkage, including one case where the lesion nearly disappeared.

　　Dr. Gong Yanchun, Co-founder and CEO of Jiangsu Vcare, stated: "VC004 is a next-generation TRK inhibitor prioritized by our company. With its unique mechanism of action and the favorable safety profile and significant clinical efficacy demonstrated in early clinical studies, we believe it has the potential to be the leading drug among similar next-generation TRK inhibitors. The approval for this pivotal Phase II clinical trial signifies full recognition and positive affirmation of VC004's pre-clinical and clinical development progress. We will accelerate its subsequent clinical development process, expediting the exploration of its safety and efficacy in patients with NTRK fusion-positive solid tumors, striving to bring this resistance-overcoming TRK targeted therapy to cancer patients as soon as possible."

　　About VC004

　　VC004 is a Class I targeted agent 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, addressing the unmet clinical need for anti-resistance therapy globally. As a next-generation therapeutic, VC004 demonstrates excellent clinical efficacy and safety. Currently, no next-generation resistance-overcoming inhibitor 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.