China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 analog Ozempic (semaglutide) has obtained clinical trial approval from the National Medical Products Administration (NMPA). The upcoming trial will assess the use of CSPC’s biosimilar in maintaining blood sugar control in patients with type 2 diabetes.
Ozempic’s Market Presence and Pending Indications in China
Ozempic was approved to treat type 2 diabetes in China in April 2021 and is currently awaiting regulatory decisions in China for a weight loss indication. The approval of CSPC’s biosimilar for clinical trials is a significant step towards expanding treatment options for diabetes patients in the country.
Advantages of CSPC’s Cateogry 2.2 Drug
CSPC’s Cateogry 2.2 drug, which is fully prepared through chemical synthesis, offers advantages such as high purity and low immunogenicity compared to semaglutide prepared using DNA recombination technology. Preclinical research results have demonstrated that CSPC’s product exhibits similar in vitro biological activity and in vivo hypoglycemic effects to semaglutide prepared using DNA recombination technology. The product has shown consistent metabolic characteristics and safety in crab-eating monkeys, with no active systemic allergic reactions and good local tolerance. Notably, there is no chemically synthetic version of this drug available anywhere in the world, making CSPC’s development a potential global first.-Fineline Info & Tech
