Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its fixed dose combination (FDC) drug, henagliflozin, metformin sustained-release tablets. This new formulation is designed to enhance blood glucose control in adult patients with type 2 diabetes when used in conjunction with diet and exercise.
The FDC sustained-release preparation combines the sodium glucose co transporter 2 (SGLT-2) inhibitor, henagliflozin, with metformin, a first-line treatment for diabetes. The approval follows the successful Phase III clinical study of the combination of henagliflozin and metformin, as well as two Phase I clinical studies: a bioequivalence study (HR20031-101) and a food impact study (HR20031-102).
On the global stage, AstraZeneca’s XigduoXR and Boehringer Ingelheim/Eli Lilly’s SynjardyX are comparable sustained-release products that are commercially available. Notably, XigduoXR received approval in the Chinese market in June 2023, highlighting the growing presence of such treatments in the global healthcare landscape.- Flcube.com
