HK Stock Market Move | HUTCHMED (00013) rose over 3% as was approved by the National Medical Products Administration for the treatment of patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements.
Hutchison China MediTech Limited (00013) rose over 3%. As of the time of writing, it has increased by 2.66%, trading at HKD 19.65, with a transaction volume of HKD 24.3634 million.
HUTCHMED (00013) surged over 3%, and as of the time of this report, it is up 2.66%, trading at HKD 19.65, with a transaction volume of HKD 24.36 million.
In terms of news, HUTCHMED recently announced that the new drug application for Fanregratinib (HMPL-453) has received conditional approval from the National Medical Products Administration (NMPA) of China. The drug is intended for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma who have previously received systemic therapy and have fibroblast growth factor receptor (FGFR) 2 fusions or rearrangements. Fanregratinib will be marketed in China under the brand name (English trademark: ATLED).
This approval is based on supportive data from the Phase II registration cohort of a pivotal single-arm, multi-center, open-label Phase II/IIIb clinical trial conducted with in China (NCT04353375). The results were recently announced at the 2026 European Society for Medical Oncology (ESMO) Gastrointestinal Cancer Congress. The study achieved its primary endpoint, showing robust and clinically meaningful responses in previously treated patients with FGFR2 fusion/rearrangement advanced intrahepatic cholangiocarcinoma, with an objective response rate (ORR) of 42.5% (95% CI: 30.0%53.6%) as assessed by an Independent Review Committee (IRC).
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