Pharmaceutical Jieankang-B (02617): Jientai® (tengotinib tablets) approved for marketing by the State Drug Administration

^{According to the Zhitong Finance App, Yaojiekang-B (02617) announced that the new drug Gentel® (tengotinib tablets) independently developed by the company has obtained conditional approval from the National Drug Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or inoperable cholangiocarcinoma who have received systemic treatment and FGFR inhibitor treatment in the past and have fibroblast growth factor receptor (FGFR) 2 fusion or rearrangement.} Previously, the treatment was included by NMPA as a priority review and a breakthrough treatment category.

Gentec ^® was conditionally approved for listing by the NMPA, based on a multi-center, open, single-arm, phase II key clinical trial conducted in China. The study results showed that as of December 27, 2025, the median follow-up time was 12 months. Among 50 patients with advanced cholangiocarcinoma, all patients had previously received at least first-line chemotherapy and an FGFR inhibitor. According to the Blind Independent Center Review (BICR) assessment, the objective response rate (ORR) was 28.0%, of which 14 patients achieved confirmed partial remission; the median duration of remission (DoR) was 8.5 months (95% CI: 5.6 to 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~-).