June 26, 2026 — Gan & Lee Pharmaceuticals (stock code: 603087.SH) announced that its independently developed insulin glargine injection has officially obtained a drug registration certificate issued by Agencia de Regulación Sanitaria (ARSA). This approval marks the company's first standalone Marketing Authorization Holder (MAH) project approved in Central America, achieving a zero-to-one breakthrough in the region. It lays a solid foundation for the company's further expansion throughout Latin America and deeper cooperation in regional healthcare programs.

Stable Supply to Support Regional Healthcare System Development

In recent years, the number of people living with diabetes in Central America has continued to rise, boosting demand for basal insulin therapy. However, insulin supply in the region remains relatively concentrated among a small number of multinational pharmaceutical companies, resulting in weak market resilience amid supply chain risks. As the global biopharmaceutical industry undergoes strategic adjustments and capacity restructuring, the shortcomings of traditional supply models have become increasingly apparent, and regional markets now have stronger demand for safe, stable, sustainable, and diversified insulin supply.

As the first enterprise in China to master industrial-scale production technology for third-generation insulin, Gan & Lee leverages its full-industry-chain platform covering R&D, manufacturing and commercialization to continuously expand global access to high-quality biologic medicines. The approval of insulin glargine injection in Honduras will further bring into play the company's advantages in mass production and international supply networks. It will deliver long-term, stable product supply to the local market and strengthen the supply resilience of diabetes medications across the region.

Global Expansion to Benefit More Patients with High-Quality Treatment

The newly approved insulin glargine injection meets stringent international standards for efficacy and safety. It provides local patients with an effective, reliable and cost-effective basal insulin regimen that substantially eases the financial burden of long-term treatment.

Meanwhile, as Chinese pharmaceutical companies enter a key phase of global development, Gan & Lee is continuing to deepen its international strategy through accumulated technical expertise and long-term industry commitment. The company has successfully expanded commercial sales of its products to 21 countries worldwide, covering Eurasia, Asia-Pacific, Latin America, Africa and other regions.

Latin America is one of the key pillars of the company's internationalization strategy. Gan & Lee's insulin product portfolio has already achieved successful commercialization in major Latin American markets including Brazil, Argentina, Mexico, Paraguay, and Bolivia, continuously supporting improvements in regional healthcare access. The approval in Honduras is another milestone in Gan & Lee's long-term commitment to the Latin American market. It further expands the company's healthcare service footprint in the region and reflects its concrete commitment to fulfilling its global health mission.

Looking ahead, Gan & Lee will continue to deepen its presence in Latin America. Leveraging regional operating platforms such as its Brazilian subsidiary, the company will steadily advance the registration and commercialization of insulin and metabolic disease therapies in more countries and regions. With its international quality system, large-scale production capabilities, and continuously improving global supply network, Gan & Lee will work with local partners to enhance access to high-quality biologic medicines and provide more stable, high-quality treatment options for people living with diabetes worldwide.

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.