Gan & Lee Receives Approval for Insulin Glargine in Ethiopia, Strengthening Presence in the African Market

BEIJING, China, January 15, 2026 — Gan & Lee Pharmaceuticals. (hereinafter referred to as "Gan & Lee"; Stock Code: 603087.SH) is pleased to announce that its independently developed insulin glargine injection and pre-filled pen, with the company acting as the Marketing Authorization Holder (MAH), have recently received registration approval from the Ethiopian Food and Drug Authority (EFDA). This milestone marks Gan & Lee's first entry into the sub-Saharan African market, laying a solid foundation for the company's expansion of diabetes treatment solutions in the region. The prevalence of diabetes in Ethiopia continues to rise annually. According to the latest data from the International Diabetes Federation (IDF), there are approximately 2.3 million adults living with diabetes in the country, including over 16,000 patients with T1D 1 . There is an urgent need for safe, affordable, and long-term glucose management options. The approval of Gan & Lee's insulin glargine provides local patients with a vital new treatment alternative. This product successfully completed a Phase 3 clinical trial in the United States in 2021. The study results confirmed that Gan & Lee's insulin glargine is highly similar to the reference listed drug in terms of immunogenicity, efficacy, and safety in both T1D and T2D patients 2 . This further validates its clinical reliability while offering both therapeutic efficacy and economic advantages to meet the long-term glucose control needs of patients. The regulatory approval in Ethiopia stands as yet another endorsement of Gan & Lee's product portfolio by international regulatory authorities. As a pioneer in China's biopharmaceutical industry, Gan & Lee has long upheld its commitment to providing high-quality treatment solutions for diabetes patients worldwide. This successful market entry into the African market not only validates the company's steadfast dedication to global health but also marks a major milestone in advancing its internationalization strategy. Looking ahead, Gan & Lee will continue to leverage its high-quality products and extensive international registration experience to actively promote the launch and application of more insulin products across Africa. We aim to help elevate local diabetes diagnosis and treatment standards, ultimately improving the quality of life for patients. Reference: 1. IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/ 2. 甘李药业甘精胰岛素（GL-GLA）完成海外三期临床研究.甘李药业. (2021, October 14). https://www.ganlee.com.cn/detail/398.html About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin ® ), fast-acting lispro injection (Prandilin ™ ), fast-acting aspart injection (Rapilin ® ), mixed protamine zinc lispro injection (25R) (Prandilin ™ 25), aspart 30 injection (Rapilin ® 30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin ® 30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine ® ). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.

The release as fetched from its publisher. ganlee.com ↗