The prevalence of cardiovascular diseases is continuously increasing in China, among which atherosclerotic cardiovascular disease (ASCVD) is the leading cause contributing more than 40% of deaths in Chinese residents. Dyslipidemia is one of the most common and dangerous risk factors of ASCVD. In particular, elevated low-density lipoprotein cholesterol (LDL-C) is the major risk factor driving the occurrence and progression of ASCVD. SINTBILO^® (tafolecimab injection), as the first domestic fully human anti-PCSK9 monoclonal antibody approved in China, provides significantly and sustained LDL-C reduction, bringing a new treatment option for cholesterol management in China.

This approval is based on the results of three Phase 3 registrational clinical trials (CREDIT-1, CREDIT-2, and CREDIT-4). The approved dosing regimens include 150 mg Q2W, 450 mg Q4W, and 600 mg Q6W, all of which are effective in reducing LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein a（Lp(a)） levels as observed in the Phase 3 registrational clinical trials. The diverse treatment regimens will provide more individualized choices for cardiologists and patients.

Prof. Junbo Ge, Zhongshan Hospital Affiliated to Fudan University, stated, "Despite decades of efforts from Chinese cardiologists, we have not seen the turning point of decline in cardiovascular events yet. We urgently need more effective therapies to manage various cardiovascular risks, reduce the incidence and relieve the burden of cardiovascular diseases in China. LDL-C is a primary causal risk of cardiovascular disease death while the current clinical management can hardly reach guideline-recommended LDL-C targets in Chinese patients; PCSK9 inhibitors will play an important role in blood lipids management. I am glad to see the first innovative domestic PCSK9 inhibitor tafolecimab is approved in Chinese market, and hope that Innovent can bring more innovative medicines to the cardiovascular disease area in the future."

Prof. Yong Huo, Peking University First Hospital, stated,"PCSK9 inhibitors are a new class of cholesterol-lowering agents that potently lower LDL-C levels with a good safety profile. Tafolecimab has demonstrated strong lipid-lowering efficacy and favorable safety in multiple Phase 3 registrational trials. Moreover, compared with imported PCSK9 monoclonal antibodies on the market, tafolecimab could be dosed in longer interval. I hope tafolecimab will provide a more accessible and high-quality lipid-lowering treatment option for the broad patients with hypercholesterolemia and mixed dyslipidemia."

Professor Yujie Zhou, Beijing Anzhen Hospital Affiliated to Capital Medical University, stated, "Patients with familial hypercholesterolemia are characterized by early onset age and high cardiovascular risk, which are of great harm to them. Patients are unable to adequately lower their LDL-C level even with combination therapy of moderate-to-high-dose statins and ezetimibe, highlighting the need for alternative strong and safe lipid-lowering agents. CREDIT-2 is the first randomized, double-blind, placebo-controlled large-scale clinical study in Chinese patients with heterozygous familial hypercholesterolemia, and the results fully validate the efficacy and safety of tafolecimab. I am pleased to see that tafolecimab is approved in China based on the results of this study and other Phase 3 registration trials, and its clinical application will certainly benefit Chinese patients with heterozygous familial hypercholesterolemia."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated," Tafolecimab has the advantage of a longer dosing interval compared with other PCSK9 monoclonal antibody agents and a significant decrease in Lp(a). As the first PCSK9 antibody with proprietary intellectual property rights in China, the clinical development of tafolecimab condensed the efforts of many domestic experts, demonstrated the recognition from the regulatory authorities, and the strength and capabilities of Innovent in the field of cardiovascular diseases. The approval of tafolecimab marks a meaningful milestone for Innovent's strategic position in the cardiovascular and metabolism (CVM) area. Innovent will uphold the mission of 'to develop high-quality biopharmaceuticals that are affordable to ordinary people ', and will bring more innovative medicines for patients with chronic diseases."