July 9, 2026, Gan & Lee Pharmaceuticals ("Gan & Lee"; stock code: 603087.SH) announced that its independently developed insulin glargine prefilled pen was granted a drug registration certificate by the Agencia de Regulación Sanitaria (ARSA). This marks another regulatory milestone for Gan & Lee in Honduras, following the approval of its insulin glargine injection in June under the company's first independently held marketing authorization (MAH) in Central America.

The newly approved prefilled pen offers convenient administration and precise, adjustable dosing, helping to improve the treatment experience of patients on long-term therapy. Complementing the insulin glargine injection already approved in Honduras, the prefilled pen is expected to provide local healthcare institutions and patients with a wider portfolio of basal insulin treatment options and better address clinical needs across different treatment settings.

In recent years, Gan & Lee has accelerated the implementation of its internationalization strategy, continuously expanding its overseas registration, market access and commercialization footprint to meet global needs for diabetes, and metabolic disease treatment. The company's insulin products have been registered and commercialized in multiple markets worldwide.

Latin America is a key pillar of Gan & Lee's international expansion. The company's products have already been marketed in Brazil, Argentina, Mexico, Paraguay, Bolivia, and other countries, contributing to the continued development of local healthcare systems. The dual approvals of insulin glargine injection and its prefilled pen in Honduras represent an important milestone in Gan & Lee's deeper expansion across Latin America and demonstrate the steady advancement of its international operational capabilities.

Looking ahead, Gan & Lee will continue to pursue innovation-driven growth while advancing its international expansion, accelerate the commercialization of additional therapies for metabolic diseases across key global markets, and further improve global access to high-quality medicines. Through these efforts, the company aims to provide patients worldwide living with diabetes and other metabolic diseases with a broader range of premium treatment options.

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.