CPHI Worldwide 2026, a leading global event for the pharmaceutical industry, concluded in Milan, Italy, on October 8, 2026. Under the theme "Precision, Innovation, and Global Access," Gan & Lee Pharmaceuticals ("Gan & Lee," stock code: 603087.SH) showcased its core product portfolio and innovative pipeline, highlighting its research and development capabilities, international strategy, and commitment to serving patients worldwide.

Throughout the event, Gan & Lee shared its expertis and advances in metabolic therapies through finished product displays, technical presentations, clinical data sharing, and international partnering discussions. These exchanges sparked interest in several potential collaborations, laying the groundwork for further expansion into overseas markets.

Innovative Pipeline and Pivotal Clinical Data Take Center Stage

Gan & Lee highlighted two key investigational therapies within its global Phase 3 development portfolio: insulin ludefen (GZR4), an ultra-long-acting, once-weekly basal insulin, and bofanglutide (GZR18), a GLP-1 receptor agonist administered once every two weeks. Featuring extended dosing intervals and promising efficacy, both candidates have the potential to reduce the burden of frequent injections and injection-related anxiety while improving treatment adherence. Both assets drew strong interest from prospective international partners.

Bofanglutide achieved a major regulatory milestone this year. In September, China's National Medical Products Administration (NMPA) accepted its marketing authorization application for long-term weight management in patients with obesity or overweight. If approved, bofanglutide could become the world's first GLP-1 weight-loss medicine administered once every two weeks, addressing an unmet need for longer-acting weight management treatments.

The pivotal Phase 3 GRADUAL-1 study of bofanglutide previously met its primary endpoint. At 52 weeks, participants receiving 24 mg and 48 mg once every two weeks achieved mean body weight reductions from baseline of 15.12% and 18.54%, respectively. More than 90% of participants achieved weight loss exceeding 5%. Bofanglutide demonstrated a favorable overall safety and tolerability profile, with adverse reactions consistent with the known safety profile of marketed GLP-1 receptor agonists and no new safety signals identified.

In addition, all three pivotal Phase 3 studies of insulin ludefen conducted in China—SUPER-1, SUPER-2, and SUPER-3—met their primary endpoints. The results demonstrated superior glucose-lowering efficacy compared with marketed third-generation, once daily basal insulins in patients with type 2 diabetes across different stages of treatment. These findings mark a further advance in the development of Gan & Lee's once weekly insulin and the progression toward a fourth generation of insulin therapies.

Established Products and Global Partnerships Drive International Expansion

Building on years of technical expertise, Gan & Lee has developed a comprehensive commercial insulin portfolio. The three core products showcased at the event were insulin glargine, insulin lispro, and insulin aspart. Each became the first Chinese insulin in its respective category to receive marketing authorization from the European Commission, demonstrating that Gan & Lee's products meet the EU's stringent regulatory requirements. Their entry into the European market demonstrates that the company's product quality, manufacturing operations, and compliance systems meet stringent international standards. To date, Gan & Lee's insulin products have received registration approvals in 57 countries, with commercial sales networks spanning 21 countries.

Gan & Lee has also expanded its international commercial network through licensing partnerships for bofanglutide with leading pharmaceutical companies across Latin America, India, South Korea, and Europe. An exclusive licensing agreement signed with a European partner in August covers 39 European countries and territories. With a potential total value of up to €726 million, including a €62 million upfront payment and milestone payments, it represents the largest overseas licensing deal for bofanglutide to date.

During CPHI, Gan & Lee held extensive discussions with pharmaceutical companies and industry organizations from multiple countries, identifying opportunities for potential cooperation on the overseas commercialization of its innovative pipeline, technical collaboration, and regional market expansion. The company presented tailored partnership models reflecting local healthcare policies, market needs, and industry landscapes, supporting both broader expansion in emerging markets and a deeper presence in established European and U.S. markets.

With nearly three decades of industry experience, Gan & Lee remains focused on patients' clinical needs worldwide and on advancing metabolic disease treatment through technological innovation. Looking ahead, the company will continue to invest in core technologies, strengthen its focus on metabolic therapies, and deepen international industry collaboration and cross-border innovation partnerships. Through these efforts, Gan & Lee aims to advance metabolic health worldwide and strengthen the global presence of China's innovative pharmaceutical sector.

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.