China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the clinical trial filing for JS010, its in-house developed CGRP monoclonal antibody drug candidate for treating migraine, has been accepted for review by the National Medical Products Administration (NMPA) in China.
About CGRP and JS010
CGRP is a neuropeptide composed of 37 amino acids, expressed in the central and peripheral nervous systems of mammals and generally divided into two subtypes: α-CGRP and β-CGRP. CGRP polypeptide levels increase during a migraine attack, which can be improved by the treatment of CGRP antagonists. Preclinical studies have shown that JS010 can bind with high-affinity to both α-and β-CGRP proteins, blocking the polypeptide’s ability to bind with the receptor. This action inhibits the intracellular cAMP signal pathway, helping to prevent the onset of migraines. Pre-clinical in vivo efficacy data show that JS010 had a significant effect in inhibiting vasodilation. Additionally, animals had good tolerance to JS010, with no significant abnormalities found during the study.
Global Landscape and Market Potential
Seven CGRP mAbs have been approved abroad, including Amgen/Novartis’s Aimovig, Teva’s Ajovy, Eli Lilly’s Emgality and Reyvow, Lundbeck’s Vyepti, Allergen’s Ubrelvy, and Biohaven’s Nurtec. However, no similar product is currently available on the market in China. The acceptance of JS010 for review by the NMPA marks a significant step forward in bringing a new treatment option for migraine to the Chinese market.-Fineline Info & Tech
