Beijing, China, Recently– Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087.SH) announced that its fast-acting insulin aspart cartridge, developed in collaboration with local pharmaceutical partner, has received marketing approval from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA).

The approval of fast-acting insulin aspart in Malaysia follows the earlier approvals of basal insulin glargine in February and premixed insulin aspart 30 in March this year, marking the third Gan & Lee insulin product approved in the country in 2025. With this latest milestone, Gan & Lee has successfully completed the full portfolio registration of basal, fast-acting, and premixed insulin analogs in Malaysia—becoming the company’s first comprehensive coverage of modern insulin products in a member country of PIC/S (Pharmaceutical Inspection Co-operation Scheme), a high-standard global GMP regulatory alliance. This achievement expands treatment options for Malaysian patients who are starting or intensifying insulin therapy.

According to the International Diabetes Federation (IDF) Diabetes Atlas (11th edition), 19.9% of Malaysian adults aged 20 to 79 are living with diabetes—approximately 4.75 million people—placing significant strain on the country’s healthcare system.

Gan & Lee’s insulin aspart, now approved in Malaysia, is a key product in the company’s insulin portfolio. The product has completed a randomized, double-blind, Phase I clinical trial in Europe, comparing its pharmacokinetics (PK) and pharmacodynamics (PD) with reference listed drug NovoRapid® / Novolog®. The study demonstrated bioequivalence in PK/PD as well as comparable safety, offering Malaysian doctors and patients a high-quality, reliable alternative for diabetes management.

As a pioneering Chinese biopharmaceutical company with global ambitions, Gan & Lee continues to strengthen its presence in emerging markets. Through local partnerships and a full product pipeline, the company is actively advancing its international strategy. The consecutive product approvals in Malaysia not only reflect the company’s adherence to PIC/S-level regulatory standards, but also highlight its strong capabilities in global regulatory affairs, technology transfer, and commercial operations at Gan & Lee.

*NovoRapid® and Novolog® are registered trademarks of Novo Nordisk for insulin aspart in Europe and the U.S., respectively.

About Gan & Lee

Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked  first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine^®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.

In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.