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BioWorld - Tuesday, February 3, 2026
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Home » Innovent scores first approval for PCSK9 inhibitor in China
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Innovent scores first approval for PCSK9 inhibitor in China

Aug. 17, 2023
By Tamra Sami
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China. The approval is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab marks Innovent's first cardiovascular drug as well as the company’s 10th approval.
BioWorld Regulatory Cardiovascular Endocrine/metabolic China NMPA

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