Beijing, China, July 5, 2024 – Global biopharmaceutical company Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087. SH) recently received a registration approval from the Directorate General of Drug Administration of Bangladesh on local-filling Insulin Aspart 30 Injection project, in cooperation with a major Bangladeshi pharmaceutical company. This approval marks the successful implementation of Gan & Lee's first overseas localized Insulin Aspart 30 project. As a leading biopharmaceutical company exporting insulin analogs from China, Gan & Lee has leveraged its innovative R&D resources to introduce advanced products and production technologies into Bangladesh, promoting localized production to enhance the accessibility and affordability of third-generation insulin in the region.

Bangladesh, located on the northeastern part of the Indian subcontinent in the delta formed by the Ganges and Brahmaputra rivers, has a total population of 170 million (2023) and a per capita GDP of USD 2,529.1 (2023). According to the 2021 "International Diabetes Federation (IDF) Atlas 10th edition," Bangladesh ranks eighth among the countries with the highest number of adults aged 20-79 living with diabetes. Approximately 13.14 million adults aged 20-79 in Bangladesh have diabetes, with a prevalence rate of 12.5%.

Bangladesh is a populous and rapidly developing country. As an emerging global market in the pharmaceutical industry, its market size has been expanding in recent years. Compared to imported original insulin, localized production can effectively reduce drug costs, ensure a stable drug supply, and promote the development and technological advancement of the local pharmaceutical industry, better meeting the medication needs of patients.

Additionally, in May this year, Gan & Lee successfully passed the EMA pre-approval inspection for GMP of substances, finished products, and pre-filled injection pens manufacturing line, signifying that the company’s production facilities comply with EU GMP regulations. The company is now capable of commercial production of Insulin Glargine Injection, Insulin Lispro Injection, Insulin Aspart Injection, and pre-filled injection pens.

Gan & Lee remains committed to global development, striving to provide more valuable treatment options for patients, healthcare professionals, and healthcare systems. In the future, the company will continue to actively collaborate with industry partners in areas such as market investment, local distribution, and market expansion, jointly exploring diversified markets, and contributing to the development of local health and hygiene sectors.

References:

1. Embassy of the People’s Republic of China in the People’s Republic of Bangladesh. (2023, July 31). Overview of Bangladesh. http://bd.china-embassy.gov.cn/mgxx/gk/201104/t20110401_1781000.htm

2. World Bank Group. (2023). Bangladesh. World Bank Open Data https://data.worldbank.org/country/bangladesh

3. IDF Diabetes Atlas 10th edition 2021. Available at: https://diabetesatlas.org/atlas/tenth-edition/

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 second overall and first among domestic 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.