CSPC Pharma gets China approval for lecanemab biosimilar clinical trials

CSPC Pharmaceutical Group Limited announced that its Lecanemab Injection, a biosimilar to LEQEMBI®, has received approval from China's National Medical Products Administration to commence clinical trials. This marks the first biosimilar to lecanemab injection approved for clinical trials in the country.

The product, a recombinant anti-human β-amyloid monoclonal antibody, is a Class 3.3 therapeutic biological product intended for treating mild cognitive impairment and mild Alzheimer's disease dementia. Pre-clinical studies demonstrated high similarity to the reference drug in quality, safety, and efficacy, supporting the initiation of human trials.

The board of directors of CSPC Pharmaceutical Group Limited, as of 25 September 2025, includes Mr. CAI Dong Chen (chairman) and other executive and independent non-executive directors.