Recently, Gan & Lee Pharmaceuticals ("Gan & Lee," stock code: 603087.SH) announced that its insulin aspart injection, manufactured by the company with Gan & Lee serving as the marketing authorization holder (MAH), received registration approval from the Ethiopian Food and Drug Authority (EFDA). It is the first insulin aspart biosimilar approved in Ethiopia. Following the clearance of its insulin glargine injection by EFDA in January 2026, Gan & Lee has secured approvals for two core insulin products in the country within a single year. Together, these approvals lay a foundation for the company's core insulin portfolio in sub-Saharan Africa and mark a new milestone in its expansion across the continent.

The number of people living with diabetes in Ethiopia has continued to grow in recent years, with substantial gaps in access to diabetes care. According to the latest data from the International Diabetes Federation (IDF), approximately 2.3 million adults in Ethiopia were living with diabetes in 2024, while more than 16,000 people lived with type 1 diabetes.¹ There is an urgent need for safe, high-quality, and affordable insulin options to meet the full spectrum of insulin treatment needs. Gan & Lee's previously approved insulin glargine delivers long-acting basal glucose control. The newly approved insulin aspart is a rapid-acting prandial insulin that complements insulin glargine, enabling comprehensive basal-bolus treatment regimens. As the first insulin aspart biosimilar approved in Ethiopia, it also expands access to high-quality, individualized diabetes care.

As a leading Chinese company in metabolic therapies, Gan & Lee has maintained a long-term focus on emerging markets, including Africa. Its core insulin products have secured approvals in several African countries, including Egypt, Algeria, and South Africa. Drawing on its extensive regional registration experience, the company is gradually moving beyond product exports toward the collaborative development of local pharmaceutical capabilities. The successive approvals of two core insulin products in Ethiopia within one year reflect regulatory recognition of Gan & Lee's product quality and standardized manufacturing systems. They also mark an important step in strengthening its regional portfolio and deepening its presence across Africa, further boosting the company's brand recognition and competitiveness in sub-Saharan Africa.

Looking ahead, Gan & Lee will draw on its established international registration capabilities and global operating experience to accelerate the registration and commercialization of innovative diabetes treatments across Africa. The company will continue to expand its overseas portfolio, support improvements in diabetes care, and reduce barriers to treatment, helping improve the quality of life for people living with diabetes worldwide.

Reference:

1.https://idf.org/news-and-resources/resources/idf-diabetes-atlas-11th-edition-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.