2023-04-04 06:06:01 ET
- 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.
For further details see:
Hutchmed starts registration phase for cancer trials after talks with Chinese regulator