China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval filings for its PCSK9 monoclonal antibody, ongericimab (JS002). The filings target heterozygous familial hypercholesterolemia and primary hypercholesterolemia, as well as mixed dyslipidemia in patients who are intolerant to or contraindicated for statins. The National Medical Products Administration (NMPA) has accepted these submissions for review.
The filings are supported by robust data from two randomized, double-blinded, placebo-controlled Phase III studies: JS002-005 and JS002-007, both demonstrating significant efficacy and tolerability for ongericimab.
Ongericimab has successfully completed two Phase III clinical trials focusing on primary hypercholesterolemia (including both heterozygous familial and non-familial cases) and mixed hyperlipidemia. Additionally, the drug has undergone a Phase II study for homozygous familial hypercholesterolemia and a Phase III trial specifically targeting heterozygous hypercholesterolemia. A major analysis has also been completed for a Phase III study involving patients with primary hypercholesterolemia and mixed hyperlipidemia who are statin intolerant and have moderate to low cardiovascular risk.- Flcube.com
