Transthera-B (02617) has announced that its independently developed Class 1 new drug, Je'ente® (Tinengotinib Tablets), has received conditional marketing approval from the National Medical Products Administration (NMPA).

The drug is indicated for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received systemic therapy and FGFR inhibitor treatment, and whose tumors harbor fibroblast growth factor receptor (FGFR)2 fusions or rearrangements.

Prior to this approval, the therapy was granted Priority Review and Breakthrough Therapy designation by the NMPA.

This conditional approval of Je'ente® is based on a pivotal, multicenter, open-label, single-arm, Phase II clinical trial conducted in China. As of December 27, 2025, with a median follow-up of 12 months, the study evaluated 50 patients with advanced cholangiocarcinoma, all of whom had received at least one prior line of chemotherapy and one FGFR inhibitor.

According to assessments by Blinded Independent Central Review (BICR): the objective response rate (ORR) was 28.0%, with 14 patients achieving confirmed partial responses; the median duration of response (DoR) was 8.5 months (95% CI: 5.6~12.5 months). The disease control rate (DCR) was 82.0%. The median progression-free survival (mPFS) was 6.0 months (95% CI: 4.4~8.3 months). The median overall survival (mOS) was 20.7 months (95% CI: 11.8~-).