April, 2022 - Keymed Biosciences (HKEX:02162) announced that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies. This is another milestone after CMG901 received Orphan-drug Designation from the FDA.

Among all the Claudin 18.2-targeted drugs, CMG901 is the first and only one which received this FDA designation so far. This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of CMG901. The dose-escalation stage of Phase I clinical trial of CMG901 in subjects with solid tumors is about to be completed in China, and the dose-expansion stage is expected to be initiated in the second quarter of 2022.

Fast Track Designation is one of the FDA's programs to accelerate the clinical development and review of new drugs to meet the unmet medical needs of serious diseases.