Beijing, China, Recently– Gan & Lee Pharmaceuticals, a leading global biopharmaceutical company (hereinafter referred to as Gan & Lee, stock code: 603087.SH)，announced that its insulin glargine injection and insulin glargine prefilled pen products, developed in collaboration with a major Malaysian pharmaceutical company in Malaysia, have received registration approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. This approval marks the first time Gan & Lee’s insulin products have entered the Malaysian market and serves as a significant milestone in the company’s internationalization strategy, laying a solid foundation for future expansion in the Southeast Asian market.

Malaysia, being a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), maintains a stringent drug regulatory system. Gan & Lee’s insulin glargine products, bolstered by their impressive clinical trial data from Europe and the United States, have successfully passed NPRA’s rigorous review process. These products, encompassing comprehensive preclinical pharmacological characteristics, PK/PD profiles, and immunogenicity features, align closely with the reference drug Lantus^® in terms of quality. This achievement highlights Gan & Lee robust capabilities in quality control and its prowess in international regulatory affairs.

As a key economic hub in Southeast Asia, Malaysia faces a high prevalence rate of diabetes. According to the International Diabetes Federation (IDF) 2021 report, the prevalence of diabetes among individuals aged 20 to 79 in the country stands at 20%, affecting approximately 4.43 million people. The approval of insulin glargine products in Malaysia, compared to second-generation insulin, demonstrates significant clinical advantages, including more stable and long-lasting blood glucose control, as well as a lower incidence of adverse reactions. The introduction of these products will not only improve access to medication and treatment adherence for local diabetes patients but also optimize the overall healthcare resource allocation for diabetes management, better addressing the growing healthcare needs of the local population.

As a leading biopharmaceutical company in China, Gan & Lee has been actively responding to the “Belt and Road” Initiative, aiming to share development opportunities with countries and regions along the “Belt and Road”. To date, the company has established stable partnerships in over 20 countries and regions, including India, Pakistan, and Kazakhstan, providing high-quality treatment solutions for diabetes patients worldwide. The breakthrough in the Malaysian market not only strengthens the deep cooperation between the two companies in production and distribution but also contributes positively to the health and well-being of the Malaysian population. Moving forward, Gan & Lee will continue to uphold the spirit of the “Belt and Road” Initiative, working hand in hand with global partners to provide better, more accessible medicines and services for patients worldwide, contributing to the establishment of a global health community.

References:

1. IDF Diabetes Atlas 10th edition 2021. Available at: https://diabetesatlas.org/data/en/country/120/my.html

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.