Gan & Lee Pharmaceuticals (Stock Code: 603087.SH) announced that its insulin glargine prefilled pen (available in 1-pen and 5-pen pack sizes) has obtained marketing approval from the Emirates Drug Establishment (EDE)of the United Arab Emirates (UAE). The UAE is the first Gulf Cooperation Council (GCC) member state to grant marketing authorization for this product.

The approval also marks Gan & Lee's first successful product registration in the GCC via its European subsidiary, Gan & Lee Pharmaceuticals Europe GmbH (based in Düsseldorf, Germany), which serves as the Marketing Authorization Holder (MAH). This represents a significant milestone in the company's global expansion strategy and paves an important pathway for the product's future commercialization across the Middle East.

The GCC is home to some of the Middle East's most developed pharmaceutical markets and is widely recognized for its rigorous regulatory frameworks, high-quality standards, and mature compliance systems. As one of the GCC's key member states, the UAE enforces internationally benchmarked standards for product registration, manufacturing quality, and post-marketing compliance, rendering it one of the region's most stringent pharmaceutical markets.

This approval carries important strategic significance for Gan & Lee. It is the company's first successful regulatory registration in the GCC under the MAH model operated by its European subsidiary, as well as the first marketing authorization secured for its insulin product in the Gulf region. This milestone not only strengthens Gan & Lee's footprint in the Middle East but also provides valuable regulatory experience and a scalable registration pathway to expand its broader product portfolio into other GCC member countries.

Diabetes remains a major public health challenge throughout the Middle East, with metabolic disease management continuing to be a healthcare priority across the region. According to the International Diabetes Federation (IDF), approximately 1.274 million adults aged 20–79 live with diabetes in the UAE, representing a prevalence of 16.5%. As diabetes care continues to advance, healthcare providers and patients increasingly seek high-quality, reliable, and easy-to-use treatment options. The approval of Gan & Lee's insulin glargine prefilled pen will further expand access to basal insulin therapy in the UAE, providing an additional long-acting insulin regimen to facilitate standardized diabetes management and enhance patient care.

Gan & Lee has continued to accelerate its global expansion strategy by advancing the registration and commercialization of its core insulin portfolio in international markets. Earlier this year, from January through May, the company's three flagship insulin products, insulin glargine, insulin aspart, and insulin lispro, successively received marketing authorizations from the European Commission, marking a historic breakthrough in the European market and further expanding the company's global footprint.

Building on years of international development, Gan & Lee has established an integrated global operating model that combines standardized R&D and large-scale manufacturing in China with the regulatory capabilities of its European subsidiary. By linking product development, global registration, quality compliance, and localized commercial operations, the company continues to enhance the global accessibility and competitiveness of its insulin portfolio.

Looking ahead, Gan & Lee will remain committed to meeting the long-term treatment needs of people living with diabetes by accelerating product registrations and commercialization in more countries and regions. By expanding global access to high-quality insulin therapies, the company aims to advance diabetes care and deliver improved health outcomes for 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.