Gan & Lee Pharmaceuticals (stock code: 603087.SH) recently received registration approval from the South African Health Products Regulatory Authority (SAHPRA) for its independently developed insulin glargine injection in both cartridge and prefilled pen presentations. This is the company's first product approved in South Africa, marking an important milestone in its registration efforts in the country and laying the foundation for commercialization and further expansion in Africa's healthcare market.

According to the 11th edition of the International Diabetes Federation (IDF) Diabetes Atlas, approximately 2.324 million adults aged 20–79 in South Africa were living with diabetes in 2024, with more than 70% lacking effective diagnosis and appropriate treatment.¹ Shortages of essential glucose-lowering medicines and gaps in standardized diabetes care have created an urgent need for high-quality, locally suitable, and readily accessible long-acting insulin products. The approval of Gan & Lee's insulin glargine is set to break the longstanding monopoly of multinational pharmaceutical companies in the local insulin market, providing healthcare professionals and patients with a new, high-quality and reliable treatment option. It is also expected to help ease the regional burden of diabetes and improve chronic disease management.

The newly approved insulin glargine is China's first independently developed long-acting insulin analogue. Since its initial approval and launch in China in 2005, the product has seen over two decades of clinical use. Featuring stable, long-lasting glucose-lowering effects and a well-established safety profile, it has become a benchmark basal insulin therapy in China and a core product in Gan & Lee's global chronic disease portfolio. The approval covers two widely used presentations: cartridges for reusable insulin pens and disposable prefilled pens. Together, these formats enable standardized clinical care and convenient administration at home, closely aligning with local treatment practices and patient needs in South Africa.

Africa is a key emerging market and an important part of Gan & Lee's international strategy. The company's insulin glargine has previously received registration approvals in Egypt and Ethiopia, where its combination of quality and accessibility is expected to broaden insulin treatment options. In addition, the approval of its insulin glargine prefilled pen in Algeria marked the company's first local insulin glargine filling project in Africa. From North Africa to East Africa and now South Africa, Gan & Lee is steadily expanding its product registrations and pathways to commercialization across the continent.

Looking ahead, Gan & Lee will continue to leverage its extensive research and development expertise in metabolic diseases, standardized manufacturing systems, and international quality management capabilities. Alongside bringing high-quality medicines developed in China to overseas markets, the company will accelerate the international expansion of its innovative drug pipeline and steadily build its footprint in emerging markets across Africa, Latin America, and Southeast Asia. Through these efforts, Gan & Lee aims to enhance global access to diabetes medicines and deliver the benefits of Chinese pharmaceutical innovation to patients 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.