The Center for Drug Evaluation (CDE) has indicated on its website that China-based Keymed Biosciences Inc. (2162.HK) has received tacit approval for its pipeline candidate drug CM383 to proceed to clinical studies. The monoclonal antibody (mAb) is intended for the treatment of Alzheimer’s disease (AD).
CM383 targets amyloid-beta (Aβ), a protein associated with the development of AD, and will be evaluated in a Phase I single dosage escalation study focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects. This development follows the recent marketing approval of Leqembi (lecanemab), another amyloid-beta targeting drug by Japan-based Eisai, which received its approval in China in January this year.- Flcube.com
