Core Viewpoint - Ganli Pharmaceutical has received marketing authorization from the European Commission for its insulin product, Ondibta®, which is intended for the treatment of diabetes in adults, adolescents, and children aged 2 years and older [1] Group 1 - Ganli Pharmaceutical and its wholly-owned subsidiary in Europe have been granted approval for Ondibta® in the EU, Iceland, Liechtenstein, and Norway [1] - Ondibta® is a long-acting insulin that requires subcutaneous injection once daily, providing a stable blood glucose control for 24 hours [1] - The product is characterized by its long duration of action, stable blood concentration without peaks, and smooth glucose control [1]

Core Viewpoint - The company and its wholly-owned subsidiary in Europe have received marketing authorization from the European Commission for its insulin injection product, Ondibta®, which is intended for diabetes treatment [1] Group 1: Product Development and Approval - The product Ondibta® has been granted marketing authorization in the EU, Iceland, Liechtenstein, and Norway [1] - The company has invested a total of 936 million yuan in research and development for this project as of September 30, 2025 [1] Group 2: Market Considerations - The expansion progress and sales scale of the product in the aforementioned regions are subject to uncertainties due to market demand, policies, exchange rates, and competition [1]

Core Viewpoint - The company has received marketing authorization for its long-acting insulin product, Ondibta®, in the EU and select European countries, which is expected to enhance its international market presence [1] Group 1: Product Approval - The company's European subsidiary has been granted marketing authorization by the European Commission for Ondibta®, a long-acting insulin injection [1] - Ondibta® is indicated for the treatment of diabetes in adults, adolescents, and children aged 2 years and older [1] - The product provides a stable blood concentration and maintains blood sugar control for up to 24 hours [1] Group 2: Market Expansion - The approval is a significant step for the company in expanding its international market footprint [1] - Future sales of the product may be influenced by market demand, regulatory environment, currency fluctuations, and competition [1]