India, May 6 -- The Center for Drug Evaluation or CDE of China's National Medical Products Administration or NMPA has granted Breakthrough Therapy Designation for IBI343 as monotherapy for the treatment of claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma or GC patients who have progressed after at least 2 lines of prior systematic treatments, Innovent Biologics said in a statement.
The Breakthrough Therapy Designation for IBI343 was based on the data from an ongoing Phase 1 study (NCT05458219), in which favorable safety and tolerability and promising antitumor activity of IBI343 monotherapy in advanced GC patients were observed. The study results will be published at an upcoming medical conference later in 20...