Gan & Lee’s Insulin Glargine Prefilled Pen Receives Marketing Approval in Thailand

Gan & Lee Pharmaceuticals. (stock code: 603087.SH) has recently obtained marketing approval from the Thai Food and Drug Administration (Thai FDA) for its independently developed insulin glargine prefilled pen, which is indicated for the treatment of diabetes. This marks another key milestone in the company's internationalization strategy and further advances its expansion across Southeast Asia. Gan & Lee's insulin glargine injection and reusable pen were previously launched in Thailand. The approval of the insulin glargine prefilled pen further expands the company's local product portfolio, providing healthcare institutions and people living with diabetes in Thailand with a more flexible and convenient option for basal insulin treatment. As a key market for the diagnosis and treatment of chronic diseases in Southeast Asia, Thailand has a large population of people living with diabetes and significant demand for standardized, long-term treatment, creating considerable potential for market growth. According to the IDF Diabetes Atlas, Thailand had 6.36 million adults aged 20–79 living with diabetes in 2024, representing a prevalence rate of 11.7%. 1 Demand is growing for basal insulin products that offer consistent quality, cost-effectiveness, and ease of administration, highlighting significant opportunities for high-quality Chinese insulin products to expand into international markets. In response to increasingly sophisticated clinical needs and stringent overseas market-access requirements, Gan & Lee has established an end-to-end manufacturing and quality control system aligned with leading global pharmaceutical standards and international regulatory requirements. Several of the company's core products have received marketing authorization from the European Commission, while its manufacturing facilities have successfully passed the pre-approval GMP inspection conducted by the European Medicines Agency. These achievements demonstrate the company's strong capabilities in quality management and international registration, laying a solid foundation for its continued growth in Southeast Asia and further expansion into global markets. Looking ahead, Gan & Lee will remain committed to innovation and internationalization. In compliance with the laws, regulations, and quality standards of each market, the company will accelerate product registrations, ensure a reliable supply, and strengthen local partnerships. Through these efforts, Gan & Lee aims to provide patients in more countries and regions with high-quality, accessible diabetes treatments and services. Reference: 1. IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/ About Gan & Lee Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline. Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin ® ; EU brand name Ondibta ® ), insulin lispro injection (Prandilin ® ; EU brand name: Bysumlog ® ), insulin aspart injection (Rapilin ® ; EU brand name: Dazparda ® ), premixed insulin lispro protamine suspension injection (25R) (Prandilin ® 25), and insulin aspart 30 injection (Rapilin ® 30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin ® 30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins. In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion. Insulin glargine injection, insulin lispro injection, and insulin aspart injection have all received marketing authorization from the European Commission (EC). Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases. Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas.

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