China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its Category 1 drug DBPR108 has achieved endpoints in two Phase III clinical studies for type 2 diabetes. The oral dipeptidyl peptidase-IV (DPP-4) inhibitor demonstrated efficacy both as a monotherapy and in combination with other drugs, recruiting over 1,000 patients in total.
Study Results
- Monotherapy Study: DBPR108 showed significant improvement in HbA1c levels at 24 weeks compared to placebo, with non-inferiority to sitagliptin.
- Combination Therapy: The drug also outperformed placebo in HbA1c reduction when used alongside other treatments.
- Safety Profile: DBPR108’s safety was comparable to sitagliptin and placebo.
Mechanism of Action
DBPR108 works by inhibiting DPP-4, increasing glucagon-like peptide-1 (GLP-1) levels, enhancing insulin secretion, and improving glucose regulation.
Market Context
China’s DPP-4 inhibitor market (excluding compound preparations) reached RMB 4 billion (USD 582.8 million) in sales in 2021, up 25% YOY. CSPC plans to file for pre-marketing communication with the NMPA soon.-Fineline Info & Tech
