Movement Alert|TRANSTHERA-B Rises 21.51% in Regular Trading, Core Drug Tinengotinib Receives NMPA Conditional Approval

Market Focus08-07

On August 7, TRANSTHERA-B rose 21.51% in regular trading, trading at HKD 13.98/share, with turnover of HKD 62.53 million.

On the news front, the company announced on August 6 that its independently developed Class 1 new drug Tinengotinib received conditional approval from China's National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have previously received systemic therapy and FGFR inhibitor treatment. The drug had previously been granted priority review and breakthrough therapy designation by NMPA. The approval was based on a multicenter, open-label, single-arm Phase II pivotal clinical trial conducted in China.

Additionally, the global registrational Phase III clinical trial of Tinengotinib for advanced cholangiocarcinoma completed patient enrollment in July, further clarifying its commercialization outlook. The company has also conducted intensive share buybacks since July, accumulating over HKD 7 million in repurchases, signaling management confidence in company value.

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