China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 therapeutic biologic product GZR4 for the treatment of diabetes.
Product Details
The half-life of long-acting basal insulin analogs currently on the market ranges from around 10 to 26 hours, or up to 1 day. Ultra-long-acting weekly insulin preparations offer several advantages, including a lower administration frequency, more stable blood drug concentration and drug effects, less day-to-day variation in blood glucose, and a reduced risk of hypoglycemia. Currently, there are no weekly insulin products available on the market globally.
Market Context
Globally, Novo Nordisk’s Icodec (Insulin 287) and Eli Lilly’s Basal Insulin Fc (BIF; LY3209590), a recombinant basal insulin weekly preparation fused to the Fc domain, are both in Phase III clinical stages.-Fineline Info & Tech
