- 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
PALO ALTO, Calif. and SUZHOU, China, Nov. 9, 2026 /PRNewswire/ -- 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."
About Hyperlipidemia
The burden of dyslipidemia in Chinese adults is still heavy. National survey data from 2020 to 2022 showed that the prevalence of dyslipidemia among Chinese adults aged ≥18 years was 38.1%. Elevated low-density lipoprotein cholesterol (LDL-C) is a pathogenic risk factor for atherosclerotic cardiovascular disease (ASCVD), and LDL-C reduction is still the primary goal of blood lipid management and ASCVD prevention and treatment.
The awareness rate, treatment rate, and control rate of dyslipidemia in China are still low; statins are still the basis for lipid-lowering therapy, and patients who do not meet the target can be treated with statin in combination with cholesterol absorption inhibitors or PCSK9 inhibitors according to the risk and treatment response. Monotherapy with a PCSK9 inhibitor is more effective in reducing LDL-C levels than cholesterol absorption inhibitors in statin-naïve or statin-intolerant populations. PCSK9 inhibitors are potent lipid-lowering agents that reduce LDL-receptor degradation and promote LDL-C clearance, some of which have been shown to reduce the risk of cardiovascular events.
About SINTBILO®
SINTBILO® (tafolecimab Injection) is a fully human IgG2 monoclonal antibody independently developed by Innovent Biologics that specifically binds to PCSK9 (proprotein convertase subtilisin/kexin type 9) molecules. It increases LDLR levels by reducing PCSK9-mediated endocytosis of the low-density lipoprotein receptor (LDLR), thereby increasing LDL-C clearance and reducing LDL-C levels.
SINTBILO® has been approved and included in the NRDL in China for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NDA review, 6 assets in Phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage.
Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the highquality outbound internationalization of China's innovative drug industry.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.
For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
