On June 5, 2026 Vcare Pharmatech reported NTRK gene fusions have been identified as oncogenic drivers in adult and pediatric patients with pan-solid tumors. A fusion gene is typically formed by the combination of an NTRK gene containing a kinase domain and its fusion partner gene. To date, more than 229 fusion partner genes have been discovered, giving rise to 358 unique fusion-tumor pairings. Patients harboring such fusions generally have a poor prognosis. For advanced solid tumor patients who do not receive targeted therapy, the median overall survival ranges from 10.2 to 12.7 months, and these patients are also at a higher risk of brain metastasis. Meanwhile, the loss of the extracellular domain in NTRK fusions renders antibody-based therapies ineffective. Currently, treatment primarily relies on small-molecule TRK inhibitors that target the kinase domain.
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In terms of tumor type distribution, NTRK fusions are characterized by rare mutations with broad tumor spectrum distribution. On one hand, the incidence of NTRK fusions reaches up to 90% in rare malignancies such as secretory breast carcinoma and infantile fibrosarcoma, and ranges from 5% to 25% in papillary thyroid carcinoma and Spitzoid melanoma. On the other hand, real-world data from approximately 295,000 solid tumor patients worldwide indicate that NTRK fusion-positive cases account for a larger absolute number of patients among common cancer types. Collectively, NTRK fusion-positive patients with non-small cell lung cancer, breast cancer, soft tissue sarcoma and colorectal cancer make up nearly 50% of all affected cases, representing the key population requiring close clinical attention. In addition, the prevalence of NTRK fusions is higher in East Asian populations, with an overall incidence of approximately 0.4% among Chinese patients. It is estimated that more than 15,000 new cases of NTRK fusion-positive solid tumors are diagnosed in China each year.4-5
Breaking News: Domestic Next-Generation Tumor-Agnostic Targeted Drug Eratrectinib Approved
On June 4, the official website of the NMPA announced that Vcare PharmaTech’s Class 1 new drug, Eratrectinib, has been approved for marketing in China. It is indicated for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions.
Efficacy Breakthrough: Eratrectinib Delivers Comprehensive Clinical Benefits
Eratrectinib is a next-generation TRK inhibitor independently developed by Jiangsu Vcare PharmaTech Co.,Ltd.. In pivotal registration clinical trials for patients with NTRK fusion-positive solid tumors, this pan-tumor anticancer agent has demonstrated outstanding efficacy and safety.
Registration study results showed an ORR of 68.5% and a DCR of 85.2%. Among patients followed up for more than 6 months, the ORR reached 89.7% and the DCR was 100%, with a mOS of 40.7 months.6
In terms of long-term clinical benefits, Eratrectinib also achieved impressive results in PFS and DOR. The 2-year PFS rate stood at 75.7% and the 2-year DOR rate hit 85.5%, fully proving that the drug can deliver sustained disease control and long-term remission for patients.
Furthermore, for patients with baseline brain metastases, the ORR was as high as 87.5%. For patients previously treated with TRK-TKIs, the ORR reached 47.4%, reflecting robust therapeutic efficacy across these patient groups.
New Hope for Patients with NTRK Fusion Resistance
As a next-generation TRK inhibitor independently developed in China, Eratrectinib delivers durable and deep tumor remission, with potent brain penetration and a favorable overall safety profile. Different from the linear structure of first-generation TRK inhibitors, Eratrectinib features a cyclic molecular structure. Structural optimization reduces off-target risks and effectively prevents the emergence of drug-resistant mutations, endowing the agent with the anti-resistance mechanisms characteristic of second-generation TRK inhibitors.
(Press release, Jiangsu Vcare PharmaTech, JUN 5, 2026, View Source [SID1234666468])