Recently, insulin aspart API of Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, 603087.SH) has obtained registration certificate（Approval No.: RG.01.01.32.322.12.20.01214/H) issued by the Indonesian Food and Drug Authority (BPOM). The approval of insulin aspart API is a significant progress for Gan & Lee’ expansion in Indonesian market. It’s the first time that Gan & Lee’s insulin aspart has obtained overseas approval, marking its continuation of advancing the globalization strategy.
Image: insulin glargine（prefilled pen）of Gan & Lee export to Indonesia
Insulin glargine (prefilled pen) of Gan & Lee had been successfully exported to Indonesia before the approval of insulin aspart API. As the first sea freight since the approval by BPOM on May 2020, the delivery has inspired new impetus into the long-term cooperation between Gan & Lee and Indonesian clients.
The insulin aspart API is available for filling to produce injection. Insulin aspart injection is fast-acting biosimilar insulin, also known as prandial insulin which can be absorbed quickly after injection and given immediately before or after meals. Compared with soluble human insulin, insulin aspart has a faster onset of action and a shorter duration of action after subcutaneous injection, conforming to after-meal insulin secretion mode of human body. Injection around meals is convenient and can improve postprandial blood glucose significantly. Therefore, insulin aspart becomes a particularly important prandial insulin in the treatment of diabetes. As of September 30, 2020, Gan & Lee has accumulatively invested RMB103 million in R&D of insulin aspart.
Indonesia is the key overseas market for Gan & Lee’s sales in Asia Pacific. As world's fourth-most-populous country, Indonesia has a population of 262 million. Of adult population between 20 to 79, Indonesia diabetics number up to 10.7 million and rank seventh worldwide (IDF2019), indicating a large demand to insulin aspart injection. The approval allows insulin aspart API of Gan & Lee to be sold in Indonesia and will further increase the global market share of Gan & Lee’s insulin products.
Since 2005, Gan & Lee has established global business networks in more than 20 countries and regions, and has developed cooperation with developed countries such as Europe and the United States in 2014. The global business of Gan & Lee is mainly divided into seven areas including North America, Europe, Asia Pacific, Latin American, Commonwealth of Independent States (CIS), Middle Eastern & Northern Africa (MENA) and Sub-Saharan Africa (SSA).
Besides the approval of insulin aspart in Indonesia, Gan & Lee has an outstanding progress in APAC globalization in 2020. In May 2020, Gan & Lee obtained GMP certificate issued by Thai Ministry of Public Health. Moreover, Gan & Lee has developed business cooperation with clients of other APAC countries, signing a series of agreements and starting registration of various products.
About Gan & Lee
Gan & Lee successfully developed the first Chinese domestic biosynthetic human insulin. At present, the company has five recombinant insulin analogs commercialized in China including long-acting glargine (Basalin®), fast-acting lispro (Prandilin®), mixed protamine zinc lispro injection (25R) (Prandilin®25), fast-acting aspart and insulin aspart 30, as well as insulin injection pen (reusable) commercialized in China.
In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance Gan & Lee’s goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities to treat various forms of cardiovascular disease, metabolic diseases, cancer, and other therapeutics.