TRANSTHERA-B (02617) opened more than 28% higher in early trading, later trimming gains to trade up 12.06% at HK$12.92, with turnover reaching HK$226 million.
The company announced last night that its self-developed Class 1 new drug, Jientai® (Tenagotinib tablets), received conditional approval from the National Medical Products Administration (NMPA) for marketing. The drug is indicated for adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have FGFR2 fusions or rearrangements and have previously received systemic therapy and FGFR inhibitor treatment.
This therapy was previously granted priority review and breakthrough therapy designation by the NMPA. It is the first innovative drug from TRANSTHERA-B to receive market approval. A pivotal Phase II clinical study showed that, as of December 27, 2025, with a median follow-up of 12 months, the objective response rate (ORR) among 50 patients with advanced cholangiocarcinoma was 28.0%, the disease control rate (DCR) was 82.0%, median progression-free survival (mPFS) was 6.0 months, and median overall survival (mOS) was 20.7 months.
Jientai® has also received "Fast Track Designation" and "Orphan Drug Designation" from the U.S. Food and Drug Administration (FDA), as well as "Orphan Drug Designation" from the European Medicines Agency (EMA) for the treatment of biliary tract cancer.
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