Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company based in China, has received approval from the U.S. Food and Drug Administration (FDA) to commence a Phase I clinical study for its insulin aspart 30 injection, a biosimilar version of Novo Nordisk (NYSE: NVO)’s pre-mixed NovoMix 30 used in diabetes treatment. This development marks a significant step forward in the company’s efforts to offer advanced diabetes care solutions.
The insulin aspart 30 injection is a pre-mixed insulin formulation, comprising a biphasic suspension that includes 30% soluble insulin aspart and 70% nucleoprotamine insulin aspart. As a third-generation insulin analog, it offers considerable benefits in terms of blood glucose control, hypoglycemia risk reduction, compliance enhancement, and healthcare cost savings.
Gan & Lee Pharma’s Rapilin 30, another biosimilar insulin aspart 30 injection, received approval in China in December 2020. Its Phase III study demonstrated high similarity to NovoMix 30 in quality, safety, and efficacy, reinforcing the company’s commitment to delivering effective and affordable diabetes treatments.- Flcube.com
