Beijing, China, Recently – Gan & Lee Pharmaceuticals, a leading global biopharmaceutical company (hereinafter referred to as Gan & Lee, stock code: 603087.SH), has announced that its insulin aspart 30, developed in collaboration with a local Malaysian pharmaceutical company, has received regulatory approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. This approval marks the first overseas approval of Insulin aspart 30 and represents a significant milestone in the company’s strategy for global expansion, thereby laying a solid foundation for further growth in the Southeast Asian market.

In recent years, Gan & Lee has been accelerating its global expansion, steadily advancing the registration and supply of its insulin products. To date, the company has obtained more than 52 international regulatory approvals, gradually establishing a comprehensive portfolio of third-generation insulin products. A short while ago, Gan & Lee’s insulin glargine was successfully approved by the NPRA of Malaysia¹, where it earned official endorsement for its exceptional clinical benefits and safety. According to data from the International Diabetes Federation (IDF) in 2021, the prevalence of diabetes among individuals aged 20 to 79 in Malaysia has reached 20%, affecting approximately 4.43 million people². As a third-generation insulin analog, insulin aspart 30 is a biphasic human insulin analog suspension containing 70% insulin protamine crystals and 30% soluble insulin aspart, offering significant advantages in blood glucose control, reducing the risk of hypoglycemia, and improving patient adherence³.

Malaysia, being a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), maintains a stringent drug regulatory system. The successive approvals of Gan & Lee's products not only demonstrate the company's robust capabilities in adhering to international quality standards, advanced manufacturing processes, and global regulatory requirements but also provide local patients with an optimized treatment option that more effectively meets their healthcare needs.

Reference:

1.  http://www.5gqz5v.com.cn/detail/1430.html

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

3.  http://www.5gqz5v.com.cn/detail/1328.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.