SINTBILO is approved in China to treat adult patients with primary hypercholesterolemia and mixed dyslipidemia. Credit: Naeblys / Shutterstock.com.

Innovent Biologics has secured approval from China’s National Medical Products Administration (NMPA) for SINTBILO (tafolecimab injection, anti-PCSK9 monoclonal antibody) to treat adult patients with primary hypercholesterolemia and mixed dyslipidemia.

SINTBILO can be used to treat primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

It is an lgG2 fully human monoclonal antibody which can attach to PCSK9 and reduce LDL-C levels by preventing PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis.

Approved dosing regimens include 150mg Q2W, 450mg Q4W, and 600mg Q6W.

These regimens have been proven effective in lowering levels of LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), lipoprotein A (Lp(a)) and apolipoprotein B (ApoB).

Approval from the NMPA is based on results from Phase III CREDIT-1, CREDIT-2 and CREDIT-4 registrational studies.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Innovent clinical development vice-president Dr Lei Qian stated: “As the first PCSK9 antibody with proprietary intellectual property rights in China, the clinical development of tafolecimab condensed the efforts of many domestic experts and 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 area.”

SINTBILO is the first drug from the company to enter the cardiovascular field.

Cardiovascular diseases are on the rise in China, with atherosclerotic cardiovascular disease responsible for over 40% of deaths among Chinese residents.