Jiangsu Hengrui Medicine (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for the drug candidate HR20031 for review. The drug is intended for type 2 diabetes patients with poorly controlled blood glucose who have previously been treated with metformin, in conjunction with diet and exercise.
Details of HR20031 and Its Indication
HR20031 is an in-house developed fixed dose compound (FDC) sustained-release formulation that includes a sodium glucose co transporter 2 (SGLT-2) inhibitor, henagliflozin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, retagliptin, and metformin. This unique combination aims to provide a comprehensive treatment option for patients with type 2 diabetes.
Clinical Trials and Efficacy
HR20031 has completed a series of studies, including a bioequivalence study (HR20031-101), food impact study (HR20031-102), and a Phase III clinical trial (SHR3824-SP2086-MET-301) in combination with monotherapies. In June 2023, the Phase III clinical study for the molecule achieved its primary efficacy endpoint, demonstrating the three-drug FDC’s superiority over the two-drug combination dose group. The study showed statistically significant differences and clinically significant changes in the relative baseline decrease in HbA1c at 24 weeks. Additionally, the three-drug FDC group displayed good safety and tolerability.
Market Potential and Uniqueness
Currently, there is no other similar FDC in sustained-release formulation available on the market in China, making HR20031 a potentially groundbreaking treatment option for patients with type 2 diabetes. The acceptance of HR20031 for review by the NMPA is a significant step towards expanding treatment options and improving patient outcomes in China.- Flcube.com
