Recently, a delegation led by Dr. Ali El-Ghamrawy, Chairman of the Egyptian Drug Authority (EDA), visited Gan & Lee Pharmaceuticals (“Gan & Lee,” stock code: 603087.SH) for discussions and a tour of its manufacturing sites. The visit by Egypt's highest pharmaceutical regulatory authority marked an important milestone in fostering mutual trust, advancing regulatory alignment, and supporting the introduction of the company's products into Egypt and the broader Middle East and Africa region. Du Kai, Executive Vice President and Chief Commercial Officer (EVP & CCO), Liu Gai, Head of the Global Department, and other key team members hosted the delegation throughout the visit.

During the meeting, the two sides discussed the company's capabilities, local manufacturing and technical support, the continued introduction of innovative medicines, and its global expansion strategy. They also held in-depth discussions on market access policies, registration and compliance pathways, commercialization challenges, and opportunities for long-term cooperation in Egypt and the broader Middle East and Africa region.

Gan & Lee presented its research and development achievements in metabolic diseases and the strengths of its insulin portfolio. The company also outlined its research and development standards, clinical trial framework, and quality control systems designed to meet the needs of global markets. The EDA delegation shared updates on Egypt's pharmaceutical regulations, review standards for imported medicines, and market access requirements, providing authoritative regulatory guidance to support the company's expansion in the region.

The delegation also toured Gan & Lee's manufacturing facilities, examining its intelligent manufacturing processes, standardized quality control practices, and systems that ensure compliance throughout production. The delegation spoke highly of the company's rigorous international manufacturing standards, reliable production capacity, and comprehensive quality management system, recognizing its product strengths and manufacturing capabilities to serve Egypt and the wider Middle East and Africa region.

Egypt is a key pharmaceutical hub in the Middle East and Africa, providing access to a broad Arab market with substantial demand for chronic disease treatments. It is therefore a priority market in Gan & Lee's international strategy. The visit enabled direct and productive engagement with Egypt's highest pharmaceutical regulatory authority, helped address information gaps related to market entry, and strengthened the company's regulatory credibility and recognition in North Africa. It also laid a solid foundation for facilitating market access for established products and preparing for the future introduction of its innovative pipeline across the region.

Looking ahead, Gan & Lee will continue to prioritize research and development and maintain high international quality standards. The company will deepen dialogue and regulatory cooperation with pharmaceutical authorities in countries participating in the Belt and Road Initiative, while steadily advancing global product registrations, market access, and commercialization. Through the delivery of high-quality, accessible innovative medicines, Gan & Lee will continue to advance its global strategy and serve patients living with chronic diseases 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.