Gan & Lee’s GZR102 Receives NMPA Clinical Trial Clearance for Type 2 Diabetes

Gan & Lee's GZR102 Receives NMPA Clinical Trial Clearance for Type 2 Diabetes

China’s Gan & Lee Pharmaceuticals (SHA: 603087) announced that it has received clinical trial clearance from China’s National Medical Products Administration (NMPA) for its Category 1 biologic drug candidate GZR102. This novel therapy combines the investigational ultra-long-acting insulin GZR4 and ultra-long-acting GLP-1 receptor agonist (GLP-1RA) GZR18 in a weekly fixed-ratio formulation, targeting type 2 diabetes (T2D).

GZR4 and GZR18: Proven Monotherapy Efficacy
Both GZR4 and GZR18, developed in-house by Gan & Lee, demonstrated excellent glycemic control, safety, and tolerability in Phase II trials for T2D. These agents have already advanced into Phase III studies as standalone therapies, establishing a strong foundation for their combined use.

GZR102: Dual Mechanism Approach
GZR102 is designed to harness the synergistic benefits of insulin for glucose regulation and GLP-1RA for weight management and β-cell preservation. This combination aims to address multiple aspects of T2D management in a single weekly administration, potentially improving patient adherence and outcomes.-Fineline Info & Tech