By Fineline Cube China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced the submission of two market filings for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia to the National Medical Products Administration (NMPA).
Phase III and II Clinical Studies Support Filings
Ongericimab is currently in a Phase III clinical study for heterozygous familial hypercholesterolemia, having successfully concluded a Phase III study in primary hypercholesterolemia and mixed hyperlipidemia, as well as a Phase II study in homozygous familial hypercholesterolemia. The market filings are supported by data from two randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies and one single-arm, open-label Phase II clinical study.
Competition in the PCSK9 mAb Market
Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab) are already marketed PCSK9 mAbs in China. Junshi Biosciences is poised to become the first domestic firm to develop a PCSK9 mAb in the country, although it faces competition from other domestic candidates such as Innovent Bio’s IBI306 and Akeso Bio’s AK102, which are also under development.-Fineline Info & Tech