• SINTBILO^®  (tafolecimab injection) monotherapy achieved significant reduction of LDL-C level, with > 60% mean LDL-C reduction after 12 weeks of treatment with 150 mg Q2W/450 mg Q4W
• SINTBILO^®  (tafolecimab injection) monotherapy significantly decreased non-HDL-C, vLDL-C, ApoB, and Lp(a) after 12-week treatment, comprehensively improving patients' blood lipids indicators.
• SINTBILO^®  (tafolecimab injection) showed favorable safety profiles, and no new safety signals were identified

 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announced today that its self-developed recombinant fully human anti-proprotein convertase subtilisin/kexin 9 (PCSK9) monoclonal antibody, SINTBILO^® (tafolecimab injection, R&D code: IBI306), has achieved its primary endpoint at week 12 in the multi-center, randomized, double-blind, placebo-controlled monotherapy Phase 3 clinical study (CREDIT-5) in Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. In this study, SINTBILO^®  (tafolecimab injection) monotherapy showed significant lipid-lowering efficacy with favorable safety and tolerability.

SINTBILO^® is the first domestically developed PCSK9 antibody therapy to be commercialized in China, and has been included in China's National Reimbursement Drug List, effective January 1, 2025. Since its launch, SINTBILO^® has benefited more than 1 million patients and has been recommended in multiple authoritative Chinese guidelines and expert consensus statements. The positive Phase 3 CREDIT-5 clinical trial result marks another milestone breakthrough for SINTBILO^® in the treatment of hyperlipidemia. Innovent plans to submit a New Indication Application for SINTBILO^® to China's National Medical Products Administration (NMPA) in the near future, which is expected to provide a more convenient first-line treatment option for the Chinese population with hyperlipidemia.

CREDIT-5 is a Phase 3 clinical study to evaluate the efficacy and safety of tafolecimab monotherapy in Chinese subjects with non-familial hypercholesterolemia and mixed hyperlipidemia. A total of 198 participants were randomized in a 2:1:2:1 ratio to receive subcutaneous injections of tafolecimab 150 mg Q2W, placebo Q2W, tafolecimab 450 mg Q4W, or placebo Q4W after a 4-week run-in period when any drug or product with lipid-lowering effects were prohibited. The primary endpoint was the percent change in LDL-C from baseline at week 12, and the key secondary endpoints were the proportion of participants with LDL-C <2.6 mmol/L, the proportion of participants with LDL-C <1.8 mmol/L, the proportion of participants with ≥50% reduction in LDL-C from baseline, and the mean change in LDL-C from baseline at week 12.

Among the 198 participants enrolled in this study, 131 received tafolecimab and 67 received placebo. The mean baseline LDL-C levels were 3.7 mmol/L and 3.8 mmol/L, respectively. 61.1% and 53.7% of the participants had mixed dyslipidemia at baseline, respectively, and 67.9% and 79.1% of the participants had low cardiovascular risk at baseline. Tafolecimab has demonstrated clinically significant efficacy and favorable safety in the above populations:

• Primary Endpoint Achieved: At week 12, the percent reduction in LDL-C from baseline in the tafolecimab group was significantly higher than that in the placebo group (150 mg Q2W: −65.19% vs. −6.61%; 450 mg Q4W: −64.01% vs. −4.31%, p-value < 0.0001). A significant decrease in LDL-C was observed 2 weeks after the first dose in the tafolecimab group, showing rapid and strong LDL-C lowering efficacy.
• Key secondary endpoints Achieved: At week 12, the proportions of participants with LDL-C < 2.6 mmol/L, < 1.8 mmol/L, and ≥ 50% decrease from baseline in LDL-C, as well as the decrease in LDL-C from baseline in each tafolecimab group were significantly higher than those in the corresponding placebo group, and the p values of inter-group differences were all < 0.0001.
• Benefits in multi-dimensional secondary endpoints: At week 12, the reductions in non-HDL-C, TC/HDL-C ratio, vLDL-C, ApoB, ApoB/ApoA1 ratio, and Lp(a) from baseline in each tafolecimab group were all higher than those in the corresponding placebo group, with Lp(a) reduced by nearly 50%; tafolecimab monotherapy can comprehensively improve lipid-related risk factors of arteriosclerotic cardiovascular disease (ASCVD) and is expected to reduce the cardiovascular risk of patients.
• Favorable Safety Profile: During the study, tafolecimab showed favorable safety and tolerability, no severe or serious TEAE occurred; no AE led to discontinuation or interruption of the study drug; and no new safety signal was observed compared with previous studies.

Professor Yida Tang from Peking University Third Hospital, Lead Principal Investigator of the study, stated: "For a long time, statins have been the first-line standard of care for hypercholesterolemia. However, some patients still suffer from poor efficacy of statin monotherapy or combination therapy due to statin intolerance, insufficient long-term medication compliance, etc. Therefore, there is an urgent clinical need for more non-statin monotherapy options with sufficient evidence-based evidence. This Phase 3 clinical study met the primary and secondary endpoints, confirming that for patients with non-familial hypercholesterolemia and mixed hyperlipidemia, tafolecimab monotherapy can bring clinically significant reductions in LDL-C and improve lipid-related risk factors of ASCVD, without the need for combination therapy with statins. This not only further validates the therapeutic value of PCSK9 monoclonal antibody as an independent lipid-lowering regimen, but also provides new clinical evidence for patients and clinicians who need non-statin treatment. It is expected to expand the options for individualized treatment of hyperlipidemia, help more patients achieve effective control of blood lipids, and better meet the challenges of long-term blood lipid management."

Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent, stated, "As the first innovative drug in Innovent's general biomedicine portfolio to receive regulatory approval and be included in China's NRDL, SINTBILO^® has been developed with a strong focus on addressing the unmet medical needs of patients with hyperlipidemia. This Phase 3 clinical study further demonstrated the therapeutic value of SINTBILO ^® in achieving significant lipid-lowering as monotherapy, providing robust clinical evidence for treatment of hyperlipidemia. We will continue to work closely with clinical experts to accelerate the translation of research findings into clinical practice, so that more patients can benefit from innovative therapist, contributing to improved long-term management of hyperlipidemia in China."