TRANSTHERA-B (02617): The new drug application for Tenofovir Alafenamide Fumarate Tablets has been accepted by the National Medical Products Administration.
China's Drug Administration (-B) announced that the new drug application for the drug Tengoti niacin tablets has been accepted by the China National Medical Products Administration Drug Evaluation Center. It is intended for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic treatment and FGFR inhibitor therapy. Prior to this, the indication for Tengoti niacin tablets had been approved for inclusion in the priority review list and breakthrough therapy list.
TRANSTHERA-B(02617) announced that the new drug application for the drug Encozotinib tablets has been accepted by the China National Medical Products Administration Drug Evaluation Center. It is intended for the treatment of adult patients with advanced, metastatic, or unresectable biliary tract cancer who have previously received at least one systemic treatment and FGFR inhibitor therapy. Previously, this indication for Encozotinib tablets has been approved for inclusion in the priority review list and breakthrough therapy list.
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