Beijing, China, Recently – Gan & Lee Pharmaceuticals, a global leader in biopharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087.SH), has announced the official approval of its self-developed insulin glargine cartridge by the Drug Regulatory Authority of Pakistan (DRAP), with Gan & Lee acting as the Marketing Authorization Holder (MAH). This approval follows the company’s successful entry into the Pakistani market in 2022 with the introduction of its insulin glargine pre-filled pen as the first biosimilar. Gan & Lee now stands as the only biopharmaceutical company in Pakistan to secure first-biosimilar approval for insulin glargine in two dosage forms, thereby reinforcing its position in the country’s diabetes treatment sector.

According to the International Diabetes Federation (IDF) Diabetes Atlas (10th Edition, 2021), Pakistan has 33 million diabetic patients aged 20-79, ranking third globally in total patient numbers, and boasts a diabetes prevalence rate of 30.8%—the highest in the world¹. The newly approved insulin glargine cartridge, alongside the pre-filled pen formulation already available in the market, provides flexible and convenient treatment options for local healthcare providers and patients. With bioequivalent quality to the originator and a more competitive pricing strategy, Gan & Lee’s insulin glargine is expected to enhance the accessibility of high-quality diabetes treatments in Pakistan.

As China’s pioneering pharmaceutical company in independently developing a comprehensive portfolio of insulin analogs, Gan & Lee is steadfastly dedicated to innovation in the treatment of diabetes and endocrine disorder. The company has established a fully integrated industrial platform that encompasses active pharmaceutical ingredients, finished formulations, and drug delivery devices. Since the inception of its global expansion strategy in 2005, the company has been actively aligning with China’s Belt and Road Initiative (BRI). Today, Gan & Lee’s products have successfully entered India, Pakistan, Brazil, Indonesia, Mexico, and other high-burden diabetes markets, covering a population of over 156 million diabetic patients1. Moving forward, Gan & Lee will continue leveraging its strong R&D and manufacturing capabilities, extensive international commercialization experience, and strategic market insights to provide affordable, high-quality treatment solutions for patients worldwide.

Reference:

1.     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  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.