Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase I clinical study for its insulin degludec and liraglutide combination drug. This molecule is a biosimilar version of Novo Nordisk’s Xultophy, the first compound preparation to combine a basal insulin analogue with a GLP-1 analogue, addressing multiple pathophysiological mechanisms of type 2 diabetes and regulating glucose homeostasis.
Novo Nordisk’s Xultophy received its first approval in China in October 2021 and was subsequently included in the National Reimbursement Drug List (NRDL) in 2022. Tonghua Dongbao’s study aims to evaluate the pharmacokinetic similarity, safety, and tolerability of its product compared to Xultophy in healthy subjects.
Meanwhile, other Chinese pharmaceutical companies, including United Laboratories, Huisheng Bio, and Yichang HEC, have also been granted clearance to enter the clinical trial phase for their Xultophy biosimilars in China.- Flcube.com