Hutchmed (China) (NASDAQ:HCM) said it consulted China's National Medical Products Administration (NMPA) and reached agreements to start the registration phase enrollments in ongoing trials of drugs HMPL-453 and savolitinib for gastric cancer.
A phase 2 trial of HMPL-453 to treat patients with intrahepatic cholangiocarcinoma (IHCC) with fibroblast growth factor receptors (FGFR) 2 fusion.
IHCC is a cancer that starts in the bile ducts.
An agreement was also reached to start the registration phase of the ongoing phase 2 trial of savolitinib to treat patients with gastric cancer with mesenchymal–epithelial transition (MET) amplification.
Hutchmed said if positive, the data from these registration phases may be used to support a future new drug application (NDA).
The first patients received the first doses in these trials in March.
AstraZeneca (NASDAQ:AZN) and Hutchmed jointly develop and commercialize savolitinib.