China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its insulin degludec and liraglutide combination drug, administering the first dose to a patient in China. This marks a significant step forward in the development of this biosimilar version of Novo Nordisk’s Xultophy.
Drug Profile and Mechanism
The combination drug targets multiple pathophysiological mechanisms of type 2 diabetes and regulates glucose homeostasis. As a Category 3.3 drug, it has demonstrated biological similarity to Xultophy in terms of pharmacokinetics.
Clinical Trial Design
The 26-week, randomized, open, multi-center, positive-controlled, parallel group Phase III study will assess the efficacy and safety of Tonghua Dongbao’s insulin degludec and liraglutide combination compared to Xultophy in Chinese patients with type 2 diabetes.-Fineline Info & Tech
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