Innovent's Tafolecimab Cuts LDL-C 65% in Phase 3 Monotherapy Trial
Suzhou – November 08, 2026 -- Innovent Biologics (HKEX: 01801) said its PCSK9 antibody SINTBILO (tafolecimab) cut LDL-C by 65.19% at week 12 as monotherapy in the Phase 3 CREDIT-5 study, meeting the primary endpoint. The company plans to file a new-indication application with China's National Medical Products Administration (NMPA) "in the near future".
CREDIT-5 trial shows placebo-adjusted LDL-C drops above 58 points in both dosing regimens
The multi-center, randomized, double-blind, placebo-controlled study enrolled 198 Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. Of these, 131 received tafolecimab and 67 received placebo. Patients were randomized 2:1:2:1 to tafolecimab 150 mg every two weeks (Q2W), placebo Q2W, tafolecimab 450 mg every four weeks (Q4W) or placebo Q4W, after a 4-week run-in during which lipid-lowering products were prohibited.