Genovate Biotechnology (健亞) announced on the 12th that the New Drug Application (NDA) for Pruligliptin / Metformin Hydrochloride Sustained-Release (SR) Tablets has been officially accepted by China's National Medical Products Administration (NMPA). The drug was developed by CSPC Pharmaceutical Group (石藥集團) under a strategic licensing agreement.

Key Asset & Partnership Details:

• The Consortium: The asset, DBPR108, originated from Taiwan's National Health Research Institutes (NHRI) and was co-developed by a consortium of six Taiwanese firms: Genovate, CCPC, YungShin, TTY Biopharm, Nanguang, and Shionogi (Taiwan).
• Regulatory Context: The monotherapy, Pruligliptin (brand name "Shanzeping" 善澤平), a novel DPP-4 inhibitor (NCE), was approved by the NMPA in January 2025. This new FDC (Fixed-Dose Combination) SR tablet aims to improve patient compliance and glycemic control.
• Mechanism of Action (MoA): Pruligliptin increases endogenous active GLP-1 levels to boost glucose-stimulated insulin secretion, while Metformin reduces hepatic glucose production and improves peripheral insulin sensitivity.
• Market Opportunity: According to the IDF Diabetes Atlas (2024), China leads the world with 148 million patients with diabetes. This FDC targets those with inadequate control on Metformin monotherapy, offering a safer profile with low risks of hypoglycemia or weight gain.

Resource: 健亞授權石藥開發之複方緩釋劑型糖尿病新藥，中國受理新藥申請