TRANSTHERA-B (02617.HK): Class 1 New Drug Jientai (Tiengotinib Tablets) Receives Conditional NMPA Approval for FGFR2 Fusion Advanced Cholangiocarcinoma

NewTimeSpace News: TransThera Sciences (Nanjing), Inc. (stock code: 02617) issued a voluntary announcement stating that the Company's self-developed Class 1 new drug, Jientai (tiengotinib 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 with fibroblast growth factor receptor (FGFR) 2 fusions or rearrangements who have previously received systemic therapy and FGFR inhibitor therapy. Previously, the therapy had been included by the NMPA in the priority review and breakthrough therapy designation programmes.

The announcement disclosed that the approval was based on a multicenter, open-label, single-arm, Phase II pivotal clinical trial conducted in China. The study results showed that as of 27 December 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), as assessed 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 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 to 8.3 months); and the median overall survival (mOS) was 20.7 months (95% CI: 11.8 to not reached).

In respect of the market background, the global cholangiocarcinoma drug market reached USD 2 billion in 2024 and is expected to grow to USD 3.2 billion by 2027, with approximately 25.2% of cholangiocarcinoma patients presenting FGFR alterations. According to a research paper published in Cancer Treatment Reviews in 2023, cholangiocarcinoma patients develop acquired resistance after FGFR inhibitor treatment, and FGFR-altered cholangiocarcinoma patients with resistance have long faced a situation with no available treatment options.

Jientai is an innovative multitarget small-molecule kinase inhibitor independently developed by the Company targeting FGFR, JAK, VEGFR and Aurora, exerting anti-tumour effects through precise targeting, lineage remodelling and immune activation. Jientai has currently initiated multiple clinical trials worldwide for solid tumours including cholangiocarcinoma, prostate cancer, breast cancer and liver cancer, and has received Orphan Drug Designation and Fast Track Designation from the US FDA for the treatment of cholangiocarcinoma, as well as Orphan Drug Designation from the European EMA for the treatment of biliary tract cancer.

The approval represents the first indication of Jientai approved in China. The Company is currently conducting a randomised, controlled, open-label, multicenter Phase III confirmatory clinical study in China comparing Jientai with chemotherapy for the efficacy and safety in patients with unresectable advanced or metastatic intrahepatic cholangiocarcinoma carrying FGFR2 fusions/rearrangements or mutations who have relapsed or progressed after first-line systemic therapy. The marketing of Jientai is expected to benefit cholangiocarcinoma patients who have previously received systemic therapy and FGFR inhibitors, filling the guideline gap in third-line treatment for advanced cholangiocarcinoma. The announcement also included the cautionary statement required under Rule 18A.08(3) of the Listing Rules that there is no guarantee that the Company will ultimately be able to successfully develop and market the relevant products.

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