By Fineline Cube China-based Innovent Biologics Inc. (HKG: 1801) has announced that a New Drug Application (NDA) filing for its recombinant fully human anti-PCSK-9 monoclonal antibody (mAb) IBI306 has been accepted for review by the National Medical Products Administration (NMPA). The application covers the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial forms) and mixed dyslipidemia.
Mechanism of Action
IBI306 is an IgG2 monoclonal antibody designed to specifically bind to PCSK-9 and reduce low-density lipoprotein cholesterol (LDL-C) levels by inhibiting PCSK-9-mediated low-density lipoprotein receptor (LDL-R) endocytosis. This mechanism enhances the clearance of LDL-C from the bloodstream.
Clinical Trial Results
The NDA filing is supported by data from three Phase III clinical studies (CREDIT-1, CREDIT-2, and CREDIT-4). These trials demonstrated that IBI306 reduced LDL-C levels by approximately 57-65% compared to a placebo, with sustained long-term therapeutic effects. Additionally, the drug significantly lowered levels of total cholesterol (TC), non-high-density lipoprotein cholesterol (Non-HDL-C), apolipoprotein B (ApoB), and lipoprotein a (Lp(a)). IBI306 has shown a high lipid-lowering efficacy and can be administered at long intervals (once every six weeks), with a favorable safety profile.
Market Landscape
Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab) are currently marketed PCSK-9 inhibitors, while Novartis’s long-acting PCSK-9 small molecule siRNA therapy Inclisiran awaits regulatory decisions in the US and Europe. In China, Innovent Biologics and Akeso are developing Tafolecimab and Ebronucimab, respectively. The global market for PCSK-9 inhibitors was valued at USD 1.24 billion in 2020.-Fineline Info & Tech