United Lab (03933) has announced that its wholly-owned subsidiary Zhuhai United Laboratories Biopharmaceutical Co., Ltd. has received acceptance from China's National Medical Products Administration for the marketing registration application of its independently developed Insulin Degludec/Liraglutide Injection (IDegLira), with acceptance number CXSS2600154.
The company is the first enterprise in China to submit a marketing registration application for a biosimilar of Insulin Degludec/Liraglutide.
Insulin Degludec/Liraglutide Injection is a long-acting combination glucose-lowering formulation composed of basal insulin degludec (IDeg) and the human glucagon-like peptide-1 (GLP-1) analogue liraglutide.
The two components maintain their respective pharmacokinetic characteristics within the combination formulation, achieving complementary advantages and synergistic effects that overcome the limitations of monotherapy, delivering around-the-clock stable glucose control, significantly improving blood glucose target achievement rates, and simultaneously addressing weight management and hypoglycemia risk control, achieving multiple clinical values of "glucose lowering, glucose stabilization, and safe weight control."
Compared with monotherapy or combination therapy, this product requires only once-daily subcutaneous injection, greatly simplifying the dosing regimen and improving long-term compliance while enhancing efficacy and safety, providing type 2 diabetes patients with a more efficient, safe, and convenient integrated treatment option.
This marketing registration application represents another important achievement for the company in the diabetes treatment field.
In the future, the company will continue to be committed to new product research and development, with a focus on enhancing its competitiveness and creativity in the biopharmaceutical industry, deepening its presence in the chronic disease treatment field, and serving clinical needs and benefiting patients with higher quality products and a more comprehensive pipeline, which is expected to create greater returns for the company and its shareholders.