China's First Independently Developed NTRK Inhibitor Eratrectinib (VELMARTO®) Receives Approval to Initiate Pivotal Clinical Trial in Pretreated Drug-Resistant Patients

　　Recently, Jiangsu Vcare PharmaTech Co.,Ltd. (Vcare PharmaTech) announced that the pivotal clinical trial of its self-developed Class 1 innovative drug VELMARTO® (generic name: Eratrectinib, research code: VC004) for patients with NTRK fusion-positive solid tumors who failed prior therapies has received official approval. This trial marks the first pivotal clinical study conducted by a China-originated NTRK innovative drug targeting pretreated patients with fusion-positive solid tumors. It signals that VELMARTO® has stepped into a systematic clinical research phase for treating drug-resistant solid tumors, further enriching the evidence-based medical data portfolio of the agent and delivering more robust treatment options for domestic patients with recurrent and drug-resistant NTRK fusion-driven solid tumors.

　　As a next-generation TRK inhibitor independently developed in China, VELMARTO® obtained conditional marketing approval from the NMPAin June 2026. It is indicated for adult and adolescent patients aged 12 years and older with locally advanced or metastatic solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions, representing a tissue-agnostic targeted innovative therapy with broad-spectrum anti-tumor activity.

　　NTRK gene fusion acts as a key driver mutation in a wide range of solid malignancies, identified in more than 45 tumor types. Currently, a subset of patients with NTRK fusion-positive solid tumors develop drug resistance and disease progression after treatment with first-generation TRK inhibitors, resulting in limited therapeutic alternatives and poor clinical prognoses. This constitutes a substantial unmet medical need. The approval of this pivotal trial for pretreated populations directly addresses the critical clinical challenge of drug resistance management.

　　The newly approved pivotal trial of VELMARTO® for pretreated patients serves as a core clinical program to expand indication coverage and tackle drug resistance post-marketing. The study will be carried out across 26 clinical research centers nationwide in China, enrolling patients with locally advanced or metastatic NTRK fusion-positive solid tumors who experienced treatment failure on prior first-generation TRK inhibitors. It will systematically evaluate the efficacy, safety and tolerability of Eratrectinib in pretreated, drug-resistant populations, with a primary focus on overcoming clinical drug resistance.

　　Through structural optimization, Eratrectinib demonstrates stronger target binding affinity and superior inhibitory activity against resistance mutations compared with conventional TRK inhibitors. It also boasts remarkable safety profiles: a lower incidence of Grade ≥3 TRAEswith no fatal adverse reactions reported. The agent effectively balances anti-tumor efficacy and treatment safety, making it suitable for long-term administration in pretreated patients.

　　In earlier registrational clinical studies, 19 pretreated patients were enrolled. Clinical data revealed an ORRof 47.4% among patients previously exposed to TRK-TKIs, fully validating the outstanding therapeutic value of Eratrectinib for pretreated and drug-resistant patients with NTRK fusion-positive solid tumors. As China’s first pivotal clinical trial specifically designed for this patient population, the approved program will further generate clinical data of VELMARTO® in pretreated, drug-resistant cohorts and strengthen its therapeutic evidence chain for relevant indications. It is expected to provide Chinese patients with recurrent, drug-resistant NTRK fusion-positive solid tumors with a higher-quality, safer domestic innovative therapeutic option and substantially lower the access barrier to precision targeted therapy for domestic patients.

　　Vcare PharmaTech will efficiently advance the progress of this pivotal clinical trial with rigorous quality control, accelerate exploration of the drug’s clinical value in niche populations including drug-resistant patients and pediatric oncology patients, and continuously optimize its product clinical pipeline. Meanwhile, the Company will remain focused on major chronic disease areas such as oncology, cardiovascular and cerebrovascular diseases, as well as inflammatory and autoimmune disorders. Adhering to original innovation, Vcare PharmaTech will develop more high-quality, accessible domestic innovative medicines to benefit a broad spectrum of patients.