Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the dosing of the first patient in a Phase II clinical study for its Category 1 therapeutic biologic product, GZR4. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes.
Design and Objectives of the Phase II Study
The multi-center, randomized, open, parallel controlled, target-driven Phase II study is primarily aimed at comparing the efficacy, safety, and tolerability of GZR4 injection administered once a week versus daily insulin degludec over a 16-week period. A secondary objective of the study is to evaluate the pharmacokinetic characteristics of GZR4 after 16 weeks of treatment.
Market Potential and Competitive Landscape
Currently, there is no weekly insulin preparation commercially available globally. Novo Nordisk’s Icodec (insulin 287) is leading in development, with market filings made in the US, EU, and China in April of this year. Additionally, Eli Lilly’s recombinant basal insulin Fc (LY3209590) is in the Phase III stage of development. The successful development and approval of GZR4 could position Gan & Lee Pharmaceuticals as a competitor in the emerging market for ultra-long-acting insulin therapies.-Fineline Info & Tech
