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.
At week 12, LDL-C fell 65.19% with 150 mg Q2W versus 6.61% with placebo. The 450 mg Q4W arm showed a 64.01% reduction versus 4.31% with placebo (p < 0.0001 for both). A significant LDL-C decrease appeared two weeks after the first dose. Mean baseline LDL-C was 3.7 mmol/L in the tafolecimab group and 3.8 mmol/L in the placebo group.
Key secondary endpoints all reach p < 0.0001 against placebo
The proportions of patients reaching LDL-C below 2.6 mmol/L, below 1.8 mmol/L and a reduction of at least 50% were significantly higher in each tafolecimab arm. Non-HDL-C, TC/HDL-C ratio, vLDL-C, ApoB and the ApoB/ApoA1 ratio also fell more than with placebo. Lp(a) dropped by nearly 50%.
In the tafolecimab group, 67.9% of participants had low cardiovascular risk at baseline, versus 79.1% in the placebo group. Mixed dyslipidemia affected 61.1% and 53.7%, respectively.
No severe adverse events recorded and no treatment discontinuations
No severe or serious treatment-emergent adverse events occurred. No adverse event led to discontinuation or interruption of the study drug, and no new safety signal appeared compared with earlier studies.
Statin-intolerant patients are the target for a first-line monotherapy label
Lead Principal Investigator Yida Tang of Peking University Third Hospital said some patients respond poorly to statins because of intolerance or weak long-term compliance. He said the results show tafolecimab works without statin combination therapy.
SINTBILO is the first domestically developed PCSK9 antibody commercialized in China. It has been on the National Reimbursement Drug List since January 1, 2025, and Innovent says it has reached more than 1 million patients. The current label covers adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, and mixed dyslipidemia.
National survey data from 2020 to 2022 put dyslipidemia prevalence among Chinese adults aged 18 and older at 38.1%. Awareness, treatment and control rates remain low, according to the company.
Lei Qian, Innovent's Chief R&D Officer for general biomedicine, said SINTBILO is the first innovative drug in that portfolio to win approval and NRDL inclusion.