On September 19, 2026, during the 2026 International Biomedical Industry Innovation Conference Beijing Forum, DIA (Drug Information Association) hosted a closed-door international regulatory meeting in Beijing titled "Face-to-Face with Brazil's ANVISA and Indonesia's BPOM". Gan & Lee Pharmaceuticals. (Gan & Lee, stock code: 603087.SH) participated by invitation, joining regulatory officials from Brazil and Indonesia and industry peers to explore opportunities and practical pathways for international cooperation in innovative medicines.

Strengthening International Regulatory Dialogue to Support Global Expansion

The meeting focused on healthcare development plans, registration requirements, and industry policies in Brazil and Indonesia, providing a platform for direct dialogue between Chinese pharmaceutical companies and regulatory authorities from both countries. As one of the participating companies, Gan & Lee shared updates on its existing partnerships and future plans in both markets, highlighting progress in developing innovative drug candidates, including bofanglutide, a twice-monthly GLP-1 receptor agonist, and insulin ludefen, a once-weekly insulin.

During the meeting, Leandro Pinheiro Safatle, President-Director of the Brazilian Health Regulatory Agency (ANVISA), commended Gan & Lee's sustained commitment to the Brazilian market and its efforts to advance the local Productive Development Partnership (Parcerias para o Desenvolvimento Produtivo, PDP) program, encouraging other Chinese pharmaceutical companies to draw on its experience. William Adi Teja, Deputy Head of the Indonesian Food and Drug Authority (BPOM), also spoke highly of the company's growth and presence in Indonesia, noting that its local partnerships had improved access to medicines. These remarks reflected the regulators' recognition of the company's overall capabilities, technical cooperation proposals, and project implementation, providing further momentum for its global partnerships.

As its international expansion progresses, Gan & Lee continues to maintain professional dialogue with regulatory authorities in key overseas markets while pursuing product registrations, submitting clinical trial applications, and conducting commercial operations in accordance with local regulatory requirements. The company has established a solid business foundation and partnership network in Brazil and Indonesia, two of its core emerging markets. This meeting further deepened the company's understanding of the latest regulatory requirements and industry policies in both countries, helping bridge cross-border gaps in regulatory information. It also provided policy context and practical guidance for future product registration submissions, ongoing regulatory compliance for existing products, and the implementation of technical cooperation projects.

Advancing Local Technology Partnerships for Shared Industrial Growth

As it expands internationally, Gan & Lee pursues a differentiated approach focused on high-quality growth. Beyond exporting products, the company builds a lasting local presence through technology sharing and long-term strategic partnerships, supporting the development of local industries and healthcare systems.

In Brazil, Gan & Lee obtained ANVISA approval for its insulin glargine injection and prefilled pen products in 2020 and subsequently began commercial supply. In 2025, the insulin glargine PDP program in which the company participates passed a national-level review. That same year, Gan & Lee signed a ten-year Technology Transfer and Supply Agreement with a public laboratory under Brazil's Ministry of Health and a local biopharmaceutical company, supporting the establishment of a local insulin production system and improving access to medicines.

In Indonesia, a core Southeast Asian market, Gan & Lee obtained registration approval for its insulin glargine prefilled pen in 2020 and completed its first commercial export shipment to the country. In 2021, it secured registration approval for insulin aspart drug substance, establishing a presence in both finished drug products and drug substances. In 2022, through a local filling and manufacturing partnership with a major Indonesian pharmaceutical company, two products were approved in succession: its insulin glargine prefilled pen and its insulin aspart prefilled pen in a five-pen pack. These milestones further strengthened local manufacturing capabilities and laid the foundation for deeper cooperation and continued market expansion.

Looking ahead, Gan & Lee will continue to uphold its corporate philosophy of "Science Excellence," guided by the needs of patients worldwide. The company will strengthen regular dialogue with regulatory authorities in overseas markets, enhance its international registration and compliance capabilities, and deepen technical collaboration and industrial cooperation with overseas partners. Through these efforts, Gan & Lee aims to bring innovative Chinese pharmaceutical technologies to the global market and help more patients in China and around the world.

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.