Jiangsu Vcare：VC004 injection approved via priority review.

The drug’s New Drug Application (NDA) was formally accepted and subsequently approved by the NMPA via priority review and conditional approval mechanisms.

VC004 is the first approved Category 1 innovative chemical drug from Jiangsu Vcare PharmaTech. It is specifically designed for patients with refractory solid tumors harboring NTRK fusion genes, with its core advantage being the significant ability to overcome resistance to traditional targeted therapies.

The drug is indicated for adults and adolescents aged 12 years and older: patients with locally advanced or metastatic solid tumors who have been tested and found to harbor NTRK fusion genes without known acquired resistance mutations, as well as those who are at high risk for surgical resection, have no satisfactory alternative therapy, or have failed prior treatment.

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