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Drug Approval · English Editorial Summary

China approves a home-grown NTRK inhibitor for tumours of any origin — and the harder problem is finding the patients

On 4 June 2026, China approved anretinib, the country's own next-generation TRK inhibitor, for adults and teenagers with NTRK fusion-positive solid tumours of any type. In the registration trial it shrank 68.5% of first-treated tumours. The remaining bottleneck, its lead investigator says, is that only about 1% of eligible patients in China are ever tested.

Original report: 4 June 2026English summary: 15 June 2026Source: Medlive (medlive.cn) physician platformEdited by Wellward China
Cancer Hospital Chinese Academy of Medical SciencesBeijingCancer & TumorsNTRK fusionDrug approvalTargeted therapyPrecision medicine
Source and editorial note: This is an original English summary based on Medlive's Chinese-language expert discussion on NTRK fusion diagnosis and treatment (approval: 4 June 2026), published 4 June 2026. It is not a full translation or an independent clinical assessment. The original source is the authority for the underlying report.
The development

A pill that works across tumour types — if you can find who needs it

NTRK gene fusions were the first "tumour-agnostic" cancer target: whatever organ the cancer arises in, if the fusion is present, drugs that block the resulting TRK protein can shrink it dramatically. The fusions are rare — 0.03% to 0.7% of most adult cancers, though up to about 90% in a few rare tumour types — and until now Chinese patients depended on imported drugs.

On 4 June 2026, China's drug regulator approved anretinib (brand name Vimaituo), a next-generation TRK inhibitor developed by Jiangsu Vcare Pharma, for adults and children aged 12 and over with NTRK fusion-positive solid tumours of any origin — the country's first home-grown drug of this class, and the third next-generation TRK inhibitor in the world. The registration trials were led nationally by Professor Shi Yuankai of the Cancer Hospital, Chinese Academy of Medical Sciences, one of China's most experienced principal investigators, under whose leadership more than twenty new drugs have reached approval.

What the trials showed

Anretinib was designed with a ring-shaped molecule intended to avoid the "solvent-front" mutations that make tumours resistant to first-generation TRK inhibitors, and to penetrate the brain.

Key results (single-arm phase 2, 54 patients, 13 tumour types)

Among first-treated patients, 68.5% had objective tumour shrinkage, with median overall survival reaching 40.7 months and 75.7% of patients progression-free at two years. Among patients whose cancer had already become resistant to earlier TRK inhibitors — a group with no other options — 47.4% still responded. In patients with brain metastases at baseline, 87.5% responded. Most side effects were grade 1–2.

Evidence status: single-arm, conditionally approved

These are single-arm phase 2 results, and the approval is conditional, as is standard for rare-target drugs. Studies in children aged 2–12 are ongoing, a phase 3 is under way, and the drug passed formal review for China's national reimbursement list in July 2026. How these numbers compare head-to-head with imported alternatives remains to be established.

The bottleneck is diagnosis, not the drug

The striking figure in the expert discussion that followed the approval was this: only about 1.3% of Chinese solid-tumour patients are ever tested for NTRK fusions. Patients with the fusion who go untested never reach the drug at all — and untreated, their median survival is under a year. The clinicians' main proposals were standardised rare-target testing pathways, better sample handling, and cheaper tests.

Relevance to international patients

Tumour-agnostic targeted therapy is a growing reason patients seek molecular tumour boards abroad; a second-generation inhibitor developed and priced in China adds a treatment option to ask about where NTRK fusion is confirmed. This summary belongs to the Cancer & Tumors health area and is not medical advice for any individual.