Innovent prepares NDA as anti-PCSK9 antibody stars in trials

Chinese biopharma firm Innovent Biologics (HKEX: 01801) has announced that its experimental anti-PCSK9 antibody, named IBI306, has come up trumps in two Phase III trials in China.

The primary endpoint was met in the CREDIT-1 study of non-familiar hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk and the CREDIT-4 trial of people with hypercholesterolemia including non-FH and heterozygous familial hypercholesterolemia (HeFH).

As of February 2022, three key registration studies of IBI306 have been completed and successfully met their goal, with the CREDIT-2 study for the treatment of Chinese HeFH patients the first to meet the primary endpoint in August 2021.