BEIJING, 2026 - Gan & Lee Pharmaceuticals. (hereinafter"Gan & Lee", Stock Code: 603087.SH) announced that its finished insulin products have successfully passed Good Manufacturing Practice (GMP) certification by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA). The certification covers two core finished products, insulin aspart and insulin lispro, and was granted to its subsidiary, Gan & Lee Pharmaceuticals of Brazil Commercial and Importer for Medicines Ltda.

In April 2026, Gan & Lee's insulin aspart and insulin lispro drug substances had also passed ANVISA GMP certification. With this latest milestone, Gan & Lee's insulin glargine, insulin lispro, and insulin aspart products have achieved dual compliance in Brazil for both drug substances and finished products. This signifies that the Company's production quality systems fully comply with Brazilian regulatory standards, laying a solid foundation for the official launch of Gan & Lee's own insulin brands in Brazil and further expansion into the Latin American pharmaceutical market.

According to data from the International Diabetes Federation (IDF), Brazil has a massive diabetes patient population, with the number of diabetic patients aged 20-79 reaching 16.62 million. Consequently, Brazil's diabetes-related healthcare expenditure ranks third globally¹. Currently, the local insulin market is mainly served by global leaders including Eli Lilly, Novo Nordisk, and Sanofi. Against this backdrop, Chinese insulin manufacturers are actively seeking to secure market share through technological advancement and strong regulatory compliance.

Gan & Lee began its strategic expansion in Brazil as early as 2014 and has since completed the registration and launch of insulin glargine in the country. Through continuous market development and deeper local presence, Gan & Lee has actively supported demand for insulin within Brazil's public healthcare system, improved access for local diabetic patients, and helped upgrade regional treatment options.

The consecutive ANVISA GMP certifications for Gan & Lee's insulin drug substances and finished products are the fruits of the Company's years of dedication to the Brazilian market. They also represent a key breakthrough for Gan & Lee in Brazil and the broader Latin American region, providing comprehensive regulatory support for the subsequent commercialization of its products while further strengthening the Company's international presence across the continent.

Notably, this certification was obtained by adding product varieties utilizing the Company's existing facilities and equipment, without additional capital investment. This demonstrates the flexibility and compatibility of Gan & Lee's production system, as well as its core strengths in cost control and resource optimization.

The two certified products, insulin aspart and insulin lispro, are both widely used rapid-acting insulin analogues with significant clinical value. Following subcutaneous injection, insulin aspart has an onset of action within 10-20 minutes, reaches a peak effect within 1-3 hours post-administration, and has a duration of action of 3-5 hours², enabling effective control of postprandial blood glucose levels. Insulin lispro also demonstrates a rapid onset of action and can be flexibly adapted to different administration scenarios, providing more targeted treatment options for the Brazilian market.

Looking ahead, Gan & Lee will continue to leverage its mature and stable production quality system and efficient resource allocation capabilities to deepen its localization strategy and commercial operations in Brazil and Latin America. The Company aims to further improve access to high-quality insulin products and expand market coverage. With high-quality, cost-effective, and highly compliant biologic medicines, Gan & Lee is committed to serving patients worldwide, steadily advancing its internationalization strategy, and helping Chinese innovative pharmaceutical companies build stronger competitiveness in the global metabolic disease treatment field.

Reference:

1. IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/

2. Chen W, Lu J, Plum-Mörschel L, et al. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023;25(12):3817-3825. doi:10.1111/dom.15281

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.