Innovent Biologics said its SINTBILO (tafolecimab injection) monotherapy met the primary endpoint in the Phase 3 CREDIT-5 trial involving Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. After 12 weeks, LDL-C reductions were 65.19% with 150 mg every two weeks and 64.01% with 450 mg every four weeks, compared with reductions of 6.61% and 4.31% in the respective placebo groups; both comparisons had p-values below 0.0001. The treatment also improved non-HDL-C, vLDL-C, ApoB, ApoB/ApoA1, the TC/HDL-C ratio and Lp(a), with Lp(a) falling by nearly 50%. No severe or serious treatment-emergent adverse event occurred, no adverse event led to treatment discontinuation or interruption, and no new safety signal was identified. Innovent plans to submit a new indication application to China’s National Medical Products Administration. SINTBILO is China’s first domestically developed PCSK9 antibody therapy to be commercialized and has been included in the National Reimbursement Drug List since January 1, 2025.