Keymed Biosciences announced that its new drug candidate CMG901 (the “Claudin 18.2 antibody drug conjugates”) for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the “FDA”) recently. Previously, in March 2021, the Company received the clinical trial application approval of CMG901 from the FDA for the clinical trial in gastric cancer and gastroesophageal junction adenocarcinoma in the United States.

“The ongoing Phase 1 trial of CMG901 demonstrated promising anti-tumor activity in advanced gastric and GEJ adenocarcinoma patients,” said Joy Yan, MD, PhD, Keymed Biosciences Chief Medical Officer, “We look forward to working closely with the FDA to finish the design of the global pivotal trial in Claudin 18.2-positive advanced gastric and GEJ adenocarcinoma”.