BEIJING, China, April 8, 2026 — Gan & Lee Pharmaceuticals. (hereinafter referred to as "Gan & Lee"; Stock Code: 603087.SH) recently announced that its drug substances have successfully passed the Good Manufacturing Practice (GMP) certification by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA). The certification was granted to its subsidiary, Gan & Lee Pharmaceuticals of Brazil Commercial and Importer for Medicines Ltda.

The successful passing of this inspection signifies that the production quality systems for Gan & Lee's insulin aspart and insulin lispro drug substances fully comply with Brazilian regulatory standards. This achievement establishes a core compliance foundation for the legal supply and subsequent commercialization of these two drug substances in the Brazilian market. It also provides critical regulatory support for Gan & Lee to further penetrate the Latin American diabetes market and advance its international insulin portfolio.

As a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) regulatory body, ANVISA's GMP certification is renowned for its rigorous standards and alignment with international norms. It is widely regarded as a benchmark for measuring a pharmaceutical company's global quality management system. This marks the first time Gan & Lee's production systems for insulin aspart and insulin lispro drug substances have passed ANVISA GMP certification.

With this milestone, all three of Gan & Lee's core insulin drug substances—insulin glargine, insulin aspart, and insulin lispro—have now obtained ANVISA GMP certification. The drug substance product matrix has expanded from a single long-acting variety to a comprehensive portfolio covering both long-acting and rapid-acting insulins. This expansion will better meet the individualized treatment needs of patients with type 1 and type 2 diabetes while further validating the company's robust technical capabilities and sophisticated quality control systems in manufacturing.

According to data from the International Diabetes Federation (IDF), the number of diabetic patients aged 20–79 in Brazil has reached 16.62 million, with a prevalence rate of 10.7%. Brazil's diabetes-related healthcare expenditure ranks third globally, making it a strategic stronghold in the global diabetes market¹. Against this backdrop, this certification will significantly enhance Gan & Lee's drug substance supply responsiveness in Brazil. It will also create strategic synergy with the company's previous exclusive commercial collaboration with a leading Latin American pharmaceutical firm for Bofanglutide. Together, these efforts aim to build a "Golden Treatment Portfolio" of classic insulin products combined with innovative GLP-1 RA products, strengthening the company's overall competitiveness in the metabolic field.

Taking this as a new starting point, Gan & Lee will continue to refine its full-chain closed-loop system encompassing "R&D/Registration—Product Supply—Commercial Access," accelerating the penetration and brand credibility of its products in the Latin American market. The company remains committed to deep cultivation in the field of diabetes treatment. Through innovation and high-quality manufacturing, Gan & Lee strives to provide safer and more accessible premium treatment solutions for patients worldwide, driving the globalization of Chinese pharmaceutical enterprises into a new era.

Reference:

1. IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-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 has received marketing authorization from the European Commission (EC), while for insulin lispro injection and insulin aspart injection, it has received the positive opinion from CHMP of EMA. 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.