Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the commencement of a Phase III clinical study for its drug candidate THDB0225, a biosimilar to Novo Nordisk’s semaglutide and Ozempic, used for the treatment of type 2 diabetes patients with inadequate glycemic control following metformin therapy.
The multi-center, randomized, open, parallel-controlled study aims to compare the efficacy and safety of THDB0225 with the reference product. THDB0225, a glucagon-like peptide-1 (GLP-1) analogue, was subject to a licensing agreement in May 2024 between Tonghua Dongbao and QL Biopharm. The agreement granted Tonghua Dongbao exclusive commercialization rights in mainland China and co-development rights internationally.
Novo Nordisk’s original semaglutide, marketed as Ozempic, received approval for diabetes treatment in the US in 2017 and was approved in China for the same indication in 2021. Phase I studies have demonstrated bioequivalence between THDB0225 and Ozempic in healthy subjects. The Phase III study, which has completed the first patient dosing, will further evaluate the pharmacokinetic (PopPK) characteristics, immunogenicity, efficacy, and safety of the biosimilar.- Flcube.com
