Palo Alto, California, USA, and Suzhou, China, November 9, 2026
Innovent Biologics has announced positive results from its Phase 3 CREDIT-5 clinical study, demonstrating significant cholesterol-lowering efficacy with SINTBILO® (tafolecimab injection) as a first-line monotherapy for adults with hyperlipidemia. The investigational treatment achieved the study’s primary endpoint at Week 12, showing substantial reductions in low-density lipoprotein cholesterol (LDL-C) among participants with non-familial hypercholesterolemia and mixed hyperlipidemia. The study evaluated tafolecimab, a recombinant fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), an important protein involved in cholesterol regulation. Results demonstrated more than 60% mean LDL-C reduction after 12 weeks of treatment with both evaluated dosing schedules. The findings also showed improvements in several additional lipid parameters, including non-high-density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), apolipoprotein B (ApoB) and lipoprotein(a) [Lp(a)]. The company reported favorable safety and tolerability, with no new safety signals identified. These findings represent an important milestone in Innovent’s cardiovascular and metabolic disease development program and support further investigation of tafolecimab as a potential treatment option for patients requiring effective cholesterol management.
Tafolecimab Demonstrates More Than 60% LDL-C Reduction
The CREDIT-5 Phase 3 clinical trial was a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of tafolecimab monotherapy in Chinese adults with non-familial hypercholesterolemia and mixed hyperlipidemia. A total of 198 participants were randomized into treatment and placebo groups. Among them, 131 received tafolecimab and 67 received placebo. Participants were assigned to receive either 150 mg every two weeks (Q2W) or 450 mg every four weeks (Q4W), with corresponding placebo regimens. The primary endpoint measured the percentage change in LDL-C from baseline at Week 12. The results showed that the 150 mg Q2W regimen achieved a 65.19% reduction in LDL-C, compared with a 6.61% reduction in its placebo group. Similarly, the 450 mg Q4W regimen demonstrated a 64.01% reduction, compared with a 4.31% reduction in the corresponding placebo group. Both treatment comparisons were highly statistically significant, with p-values below 0.0001. Researchers also observed significant LDL-C reductions as early as two weeks after the first administration. These findings demonstrate the potential of tafolecimab to deliver substantial cholesterol reductions through two different dosing schedules.
Improvements Across Multiple Cardiovascular Risk Markers
In addition to meeting its primary endpoint, the study achieved its key secondary endpoints. A significantly higher proportion of participants receiving tafolecimab reached LDL-C levels below 2.6 mmol/L and 1.8 mmol/L, while more participants achieved at least a 50% reduction from baseline compared with placebo. The treatment also demonstrated improvements in several additional lipid-related measurements associated with atherosclerotic cardiovascular disease (ASCVD). These included reductions in non-HDL-C, total cholesterol-to-HDL-C ratio, VLDL-C, ApoB and the ApoB/ApoA1 ratio. Notably, lipoprotein(a) levels decreased by nearly 50% following 12 weeks of treatment. Lp(a) is an inherited lipoprotein associated with increased cardiovascular risk, making its reduction an important finding for further clinical investigation. Tafolecimab works by binding to PCSK9, preventing PCSK9-mediated degradation of low-density lipoprotein receptors (LDLR) on liver cells. This mechanism increases the availability of LDL receptors, allowing the liver to remove more LDL cholesterol from the bloodstream. The findings suggest that tafolecimab monotherapy may offer a valuable non-statin treatment approach for selected patients who require additional cholesterol-lowering options.
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Innovent Plans Regulatory Expansion for SINTBILO
The CREDIT-5 findings further strengthen the clinical development and commercial potential of SINTBILO® (tafolecimab). The treatment is already approved in China for adults with primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia. It is also included in China’s National Reimbursement Drug List, effective January 1, 2025. Following the positive Phase 3 results, Innovent plans to submit a New Indication Application to China’s National Medical Products Administration (NMPA) to expand the treatment’s approved use. The company aims to provide an additional monotherapy option for patients who may not achieve adequate cholesterol control with existing approaches or who have difficulties tolerating statins. According to Innovent, the latest clinical findings reinforce its commitment to developing innovative therapies for cardiovascular and metabolic diseases. However, longer-term studies will be important to determine whether the observed improvements in lipid biomarkers translate into reductions in cardiovascular events. Overall, the CREDIT-5 results represent a significant clinical development milestone for tafolecimab, supporting its potential role in expanding treatment options for hyperlipidemia and improving long-term cholesterol management.
Source: Innovent Biologics press release
