Hutchison China MediTech Announces Approval of Ayvadex® (Fanregratinib) for Treatment of FGFR2 Fusion/Rearranged Intrahepatic Cholangiocarcinoma Patients in China

Hutchison China MediTech, also known as HUTCHMED (NASDAQ/LSE: HCM; HKEX: 13), disclosed that the new drug application for Fanregratinib (HMPL-453) has received conditional approval from the China National Medical Products Administration (‘NMPA’) for the treatment of advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (‘ICC’) adult patients with FGFR2 fusion or rearrangement who have previously received systemic therapy. Fanregratinib, to be marketed in China under the trade name Ayvadex® (ATLED®), is an efficient and selective oral FGFR 1/2/3 inhibitor. In the global population of ICC patients, approximately 10-15% are identified with FGFR2 fusion or rearrangement.