Innovent’s Sintbilo Lowers LDL-C About 65% in Phase 3 Trial

Innovent Biologics said in a November 8, 2026 announcement that its Phase 3 CREDIT-5 trial met its primary endpoint, with SINTBILO (tafolecimab) reducing low-density lipoprotein cholesterol (LDL-C) by up to 65.19% after 12 weeks as monotherapy. The company plans to submit a new-indication application to China’s National Medical Products Administration (NMPA), seeking first-line use without statins for a drug that is already commercialized and reimbursed in China.

The randomized, double-blind, placebo-controlled study enrolled 198 Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. After a four-week run-in during which lipid-lowering drugs and products were prohibited, participants received subcutaneous tafolecimab at 150 mg every two weeks or 450 mg every four weeks, or matching placebo. Overall, 131 participants received tafolecimab and 67 received placebo.

Mean baseline LDL-C was 3.7 mmol/L in the tafolecimab group and 3.8 mmol/L in the placebo group. Most participants were classified as having low cardiovascular risk: 67.9% of those receiving tafolecimab and 79.1% of those receiving placebo.

At week 12, LDL-C fell 65.19% from baseline with the 150 mg regimen, compared with 6.61% for the corresponding placebo group. The 450 mg regimen produced a 64.01% reduction, versus 4.31% with its corresponding placebo. Both comparisons had p-values below 0.0001. The company also reported a significant LDL-C decrease two weeks after the first tafolecimab dose.

Secondary Lipid Measures and Safety

The key secondary endpoints also favored both tafolecimab regimens over their corresponding placebo groups. These included attainment of LDL-C below 2.6 mmol/L or 1.8 mmol/L and reductions of at least 50% from baseline, with all between-group p-values below 0.0001. The announcement did not disclose the actual proportions of participants reaching those thresholds.

The effect extended beyond LDL-C. Innovent reported larger reductions than placebo in non-HDL-C, very-low-density lipoprotein cholesterol, apolipoprotein B and lipoprotein(a), with lipoprotein(a) reduced by nearly 50%. These are lipid-marker results; CREDIT-5 was not reported as demonstrating a reduction in cardiovascular events.

On safety, Innovent reported no severe or serious treatment-emergent adverse events during the study. No adverse event led to interruption or discontinuation of the study drug, and no new safety signal was observed relative to earlier tafolecimab studies.

Professor Yida Tang of Peking University Third Hospital, the study’s lead principal investigator, framed the findings as relevant to patients who have inadequate responses to statins, cannot tolerate them or have insufficient long-term adherence. Tang said the trial showed clinically significant LDL-C reduction “without the need for combination therapy with statins.”

Existing Approval and Commercial Context

Tafolecimab is a fully human IgG2 monoclonal antibody that binds PCSK9. By reducing PCSK9-mediated LDL-receptor endocytosis, it increases LDL-receptor levels and the clearance of LDL-C from the blood.

The proposed first-line use would differ from the drug’s existing approved role. Innovent’s August 16, 2023 approval announcement described SINTBILO as an adjunct to diet, used with statins or with statins and other lipid-lowering therapies, for adults with primary hypercholesterolemia and mixed dyslipidemia who had not reached LDL-C goals on moderate or higher statin doses.

That approval was based on the CREDIT-1, CREDIT-2 and CREDIT-4 trials. It covered doses of 150 mg every two weeks, 450 mg every four weeks and 600 mg every six weeks. CREDIT-5 evaluated only the first two regimens, without background lipid-lowering treatment.

SINTBILO was included in China’s National Reimbursement Drug List effective January 1, 2025. Innovent says it is the first domestically developed PCSK9 antibody therapy commercialized in China and has benefited more than one million patients since launch.

The regulatory submission remains a plan rather than a completed filing. Whether NMPA approves the proposed indication will determine if the CREDIT-5 results can expand SINTBILO’s role from add-on therapy for patients not at their LDL-C goals to first-line monotherapy.