China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its JS010, an in-house developed CGRP-targeted monoclonal antibody (mAb) drug candidate for the treatment of migraines.
CGRP and Its Role in Migraines
CGRP is a neuropeptide composed of 37 amino acids, expressed in the central and peripheral nervous systems of mammals. It is generally divided into two subtypes: α-CGRP and β-CGRP. CGRP polypeptide levels increase during a migraine attack, and this can be mitigated by the treatment of CGRP antagonists.
Mechanism of Action and Preclinical Results
Preclinical studies have shown that JS010 can bind with high affinity to both α- and β-CGRP proteins, blocking their ability to bind with the receptor. This action inhibits the intracellular cAMP signal pathway, helping to prevent the onset of migraines. In vivo efficacy data indicate that JS010 had a significant effect in inhibiting vasodilation. Additionally, animals demonstrated good tolerance to JS010, with no significant abnormalities observed during the study.
Global Context and Market Potential
While eight CGRP mAbs have been approved abroad, none are currently available in China. The approval of JS010 for clinical trials marks a significant step towards addressing this gap and providing a potential new treatment option for migraine patients in the country.-Fineline Info & Tech
