Innovent's SINTBILO meets Phase 3 CREDIT-5 goal as first-line cholesterol-lowering monotherapy

What's the deal? Innovent Biologics, the Chinese biopharmaceutical company, announced on 8 November 2026 that its cholesterol-lowering drug SINTBILO (tafolecimab) met the primary endpoint in the Phase 3 CREDIT-5 study, used as first-line monotherapy (treatment on its own, without other lipid-lowering drugs) for hyperlipidaemia — abnormally high levels of fats in the blood.

What the data showed: In 198 Chinese participants with non-familial hypercholesterolaemia and mixed hyperlipidaemia, tafolecimab 150 mg every two weeks cut LDL cholesterol — the "bad" cholesterol — by 65.19% at week 12 versus a 6.61% reduction with placebo, and the 450 mg every four weeks regimen cut it by 64.01% versus 4.31% on placebo (p<0.0001 for both). The drug also improved other blood-lipid measures, including non-HDL cholesterol and apolipoprotein B, and showed a favourable safety profile with no new safety signals.

Why it matters: Tafolecimab is a fully human antibody targeting PCSK9, a protein that regulates cholesterol levels in the blood. High LDL cholesterol is a major driver of heart attack and stroke, and a convenient every-four-weeks dosing option could improve adherence versus the daily statins many patients struggle to take consistently. Innovent plans to file a new-indication application with China's drug regulator, the NMPA, in the near future. SINTBILO is already approved in China as an add-on to statins for high cholesterol.

Read more: Innovent Biologics via PR Newswire, 08 November 2026