UNITED LAB (03933): Marketing registration application for insulin degludec and liraglutide injection accepted
UNITED LAB (03933) announced that the marketing registration application for insulin degludec and liraglutide injection (IDegLira), independently developed by Zhuhai United Biopharmaceutical Co., Ltd., a wholly-owned subsidiary of the Company, has been accepted by China's National Medical Products Administration, with acceptance number CXSS2600154. The Company is the first enterprise in China to submit a marketing registration application for an insulin degludec and liraglutide biosimilar.
UNITED LAB (03933) announced that the marketing registration application for insulin degludec and liraglutide injection (IDegLira), independently developed by its wholly-owned subsidiary Zhuhai United Biopharmaceutical Co., Ltd., has been accepted by China's National Medical Products Administration, with acceptance number CXSS2600154. The company is the first in China to submit a marketing registration application for a biosimilar of insulin degludec and liraglutide injection.
Insulin degludec and liraglutide injection is a long-acting combination glucose-lowering preparation composed of the basal insulin 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 preparation, achieving complementary advantages and synergistic effects, overcoming the limitations of monotherapy, enabling all-day stable glucose control, significantly improving blood glucose target achievement rates, and simultaneously addressing weight management and hypoglycemia risk control, delivering the 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, substantially simplifying the dosing regimen and improving long-term compliance while enhancing efficacy and safety, providing a more efficient, safe, and convenient integrated treatment option for patients with type 2 diabetes.
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 practice 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.
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