Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Organon’s (NYSE: OGN) Liptruzet (ezetimibe, atorvastatin), becoming the first such product approved in China. The drug, used to treat hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), was approved in September 2023.
Drug Profile
Liptruzet combines ezetimibe and atorvastatin, two cholesterol-lowering agents, to address hypercholesterolemia. Sinopep-Allsino’s generic version aims to provide a cost-effective alternative, expanding treatment access in China.
Company Background
Sinopep-Allsino, a leading CDMO, focuses on developing and manufacturing generic drugs. The NMPA approval underscores its R&D capabilities and positions the firm to capitalize on growing demand for affordable therapies.
Strategic Outlook
The approval marks a milestone for Sinopep-Allsino, enabling it to enter the lipid-regulation market. With Liptruzet’s patent expiry, the company plans to leverage its manufacturing expertise to supply the domestic market and explore export opportunities.-Fineline Info & Tech
