Sino Biopharmaceutical Ltd (HKG: 1177), a leading Chinese pharmaceutical company, has announced the initiation of a Phase III clinical study for its semaglutide biosimilar in China. The study is assessing the drug as a potential treatment for type 2 diabetes.
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist originally developed by Denmark-based Novo Nordisk, received marketing approval in China in April 2021 for blood sugar control in patients with type 2 diabetes. Currently, there is no biosimilar version of semaglutide available in the Chinese market. As the first weekly GLP-1 preparation in China to combine hypoglycemic and cardiovascular protection indications, the drug boasts a relatively long half-life and generated over USD 10 billion in global sales for Novo Nordisk in 2022. The Phase III study, led by Nanjing Drum Tower Hospital, is expected to enroll 492 patients to evaluate the safety and efficacy of the biosimilar in type 2 diabetes patients.
Semaglutide’s China patents were anticipated to expire no earlier than 2026. However, in 2021, Huadong Medicine challenged the patents, leading to the China Intellectual Property Administration (CNIPA) canceling or partially canceling several of the drug’s patents in 2022. Novo Nordisk is currently appealing this decision in the Beijing Intellectual Property Court.- Flcube.com
