Gan & Lee Pharmaceuticals (603087.SH): The Market Authorization Application (MAA) for Gan & Lee's insulin injection (Ondibta) has received positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

Gan & Lee Pharmaceuticals (603087.SH) announced that its European subsidiary, Gan & Lee Pharmaceuticals Europe GmbH (referred to as "Gan & Lee Europe"), recently received a notification from the European Medicines Agency (EMA) that their insulin glargine injection (trade name: Ondibta) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. CHMP has recommended that the European Commission (EC) approve Ondibta as a biosimilar of Lantus SoloStar, for the treatment of diabetes in adults, adolescents, and children aged 2 and above. The recommendation from CHMP will now enter the review stage by the EC to obtain marketing authorization for Ondibta in the European Union, Iceland, Liechtenstein, and Norway. A final decision is expected to be made by early next year.