In three Phase 3 registrational clinical trials, there were clinically meaningful and statistically significant decreases from baseline in TC, non-HDL-C, ApoB, and Lp(a) levels
China’s NMPA headquarter. (Credit: N509FZ from Wikimedia Commons)
China-based Innovent Biologics has received China’s National Medical Products Administration (NMPA) approval for SINTBILO (tafolecimab injection) to treat adult patients with primary hypercholesterolemia and mixed dyslipidemia.
SINTBILO is an lgG2 fully human monoclonal antibody that can specifically bind to PCSK9 and reduce LDL-C levels.
The PCSK9 inhibitor is the first such domestic product approved in China and is Innovent’s first drug in the cardiovascular field, as well as the firm’s 10th product in its commercial portfolio.
This approval is based on the results of three Phase 3 registrational clinical trials, including CREDIT-1, CREDIT-2, and CREDIT-4.
The approved dosing regimens include 150 mg Q2W, 450 mg Q4W, and 600 mg Q6W.
All doses were found 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 in the Phase 3 trials.
The biotechnology company said that the diverse treatment regimens will offer more customised options for cardiologists and patients.
Innovent clinical development VP Lei Qian said: “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.”
CREDIT-1, CREDIT-2 and CREDIT-4 trials are randomised, double-blind, placebo-controlled phase 3 clinical studies to assess the safety and efficacy of tafolecimab in Chinese patients.
In all 3 clinical studies, there were clinically meaningful and statistically significant decreases from baseline in TC, non-HDL-C, ApoB, and Lp(a) levels.