By Fineline Cube 
China-based Innovent Biologics Inc. (HKG: 1801) announced that it has received market approval from the drug regulatory authorities in Macau for its Xinbiyue (tafolecimab). This marks the first approval of a domestically developed proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody (mAb) in Macau, offering a new treatment option for patients with hypercholesterolemia and mixed dyslipidemia in the region.
Indications and Mechanism
The approval covers the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia in adult patients. The primary goal is to reduce levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (ApoB).
Product Advantages
Tafolecimab is the only domestically developed PCSK9 mAb currently included in China’s National Reimbursement Drug List (NRDL). It demonstrates superior efficacy due to its high affinity and can be stored at room temperature for up to 30 days, significantly improving convenience for patients. Additionally, the advanced injection device reduces administration pain, enhancing patient compliance.-Fineline Info & Tech