TRANSTHERA-B(02617): Jientai (Tian Geketin Tablets) has been approved for marketing by the National Medical Products Administration.

TRANSTHERA-B (02617) announced that its self-developed Class 1 new drug Jie'entai (Tengotinib Tablets) has received conditional approval for marketing from the National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received systemic therapy and FGFR inhibitor treatment, and have fibroblast growth factor receptor (FGFR)2 fusion or rearrangement. The therapy was previously included in the NMPAs priority review and breakthrough therapy designation. The conditional approval for Jie'entai by the NMPA is based on a multi-center, open-label, single-arm, Phase II pivotal clinical trial conducted in China. The study results indicated that as of December 27, 2025, with a median follow-up of 12 months, among 50 patients with advanced cholangiocarcinoma, all of whom had previously received at least one line of chemotherapy and one FGFR inhibitor treatment, the blinded independent central review (BICR) assessment showed: 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: 5.612.5 months). The disease control rate (DCR) was 82.0%. The median progression-free survival (mPFS) was 6.0 months (95% CI: 4.48.3 months). The median overall survival (mOS) was 20.7 months (95% CI: 11.8-).