• China’s NMPA cleared TransThera’s Yochanra for FGFR2 fusion- or rearrangement-positive advanced cholangiocarcinoma following prior systemic therapy and an FGFR inhibitor.
• Decision relied on a China Phase II study in 50 patients; ORR 28%, median PFS 6 months, median OS 20.7 months.
• Product previously received FDA fast-track and orphan-drug designations, EMA orphan-drug designation, NMPA priority review and breakthrough therapy status.

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