Breakthrough for Next-Generation TRK Inhibitor: Jiangsu Vcare's New Anti-tumor Drug, Eratrectinib (VC004) Capsules, Receives NDA Acceptance

　　Recently, the NDA for Eratrectinib (VC004) capsules, a next-generation anti-resistance TRK inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) has been officially accepted by China's NMPA. Previously granted priority review designation, the drug holds promise as a new treatment option for patients with advanced solid tumors.

　　Eratrectinib capsules, a Class 1 small-molecule targeted anti-tumor innovative drug developed by Jiangsu Vcare, effectively addresses the critical challenge of drug resistance in current cancer therapies. The drug is intended for adult and adolescent (12 years and older) solid tumor who meets the following criteria: harboring a NTRK fusion gene; diagnosed with locally advanced or metastatic disease, or where surgical resection may cause severe complications; and lacking satisfactory alternative treatment options or having experienced failure of prior therapy.

　　In the field of oncology, NTRK fusion genes are recognized as a "high-value target" due to their "tumor-agnostic" nature. They occur across dozens of adult and pediatric tumor types, including soft tissue sarcoma, lung cancer, colorectal cancer, breast cancer, and thyroid cancer. Although first-generation TRK inhibitors are available globally, patients universally face the challenge of acquired resistance following long-term treatment. Eratrectinib capsules, leveraging a unique resistance-overcoming mechanism, have demonstrated significant inhibitory activity against both wild-type and mutant TRK kinases in“in vitrokinase assays”, positioning it as a potential key solution for patients with resistance .

　　Eratrectinib capsules have exhibited outstanding efficacy and a favorable safety profile in Phase I/II clinical studies. Data from its Phase I trial were presented at the 2024 ASCO Annual Meeting. Existing data robustly validates the drug's significant efficacy not only in treatment-naïve patients but also its pronounced advantages for patients with resistance and those with refractory brain metastases. Eratrectinib capsules are now at the forefront of China's next-generation anti-resistance TRK inhibitors and are expected to address a current clinical gap. Concurrently, the drug is being developed for the global market, with an IND application already approved by the U.S. FDA.

　　Given the distinct clinical advantages over existing treatments in terms of safety, efficacy, and accessibility, Eratrectinib capsules were included in the Priority Review list by the NMPA in May 2025. Under current policies, during the NDA stage, Eratrectinib qualifies for the Priority Review procedure. This entails prioritized scheduling for registration inspection, registration testing, and review of the proposed INN, significantly expediting the drug's path to market.

　　About Eratrectinib

　　Eratrectinib (VC004) is a Class I small molecule targeted anti-tumor innovative drug independently developed by Jiangsu Vcare. As a next-generation TRK inhibitor, it has demonstrated superior efficacy compared to first-generation drugs targeting the same mechanism in clinical settings and addresses the issue of acquired resistance associated with first-generation drugs. It holds promise for delivering longer survival benefits and improved quality of life for patients. Currently, all first-generation drugs targeting this mechanism in the Chinese market are imported and have not yet received full marketing approval; furthermore, no second-generation drugs targeting this mechanism have been approved in China. This highlights the significant unmet clinical need. Eratrectinib possesses the following differentiated advantages:

　　1. Unique Second-Generation Anti-Resistance Mechanism: Based on in vitro kinase assay results, Eratrectinib not only exhibits comparable inhibitory activity against wild-type TRK to first-generation drugs in the same class but also demonstrates activity against first-generation drug resistance mechanisms. Its inhibitory potency against TRK mutant kinases reaches the nM level.

　　2. Significant Efficacy in Both Treatment-Naïve and Pre-Treated Patients: Based on results from the single-arm, pivotal Phase II clinical study, Eratrectinib demonstrated a higher clinical ORR than first-generation drugs. It also achieved favorable therapeutic outcomes in TRK TKIs pre-treated patients, further validating the differentiated advantages identified during the drug discovery phase in clinical studies.

　　3. Improved Clinical Safety Profile: The incidence of Grade ≥3 TRAEs was significantly lower compared to other drugs targeting the same mechanism, with no fatal TRAEs reported.

　　Eratrectinib is advancing in China through a single-arm Phase II trial as its pivotal clinical study, with an NDA submission imminent. Its IND application in the United States has already been approved, positioning it as a potential globally leading next-generation TRK inhibitor.

　　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 demonstrated remarkable efficacy in clinical practice, holding immense potential in the field of oncology. In China, NTRK gene fusion mutations are observed in prevalent cancer types such as lung cancer, colorectal cancer, breast cancer, and thyroid cancer, as well as in certain rare cancers, including secretory breast carcinoma and salivary gland secretory carcinoma.

　　Nat Rev Clin Oncol. 2018 Dec;15(12):731-747.