Beijing, China/Bridgewater, New Jersey U.S, July 8, 2022 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that China’s National Medical Products Administration (NMPA) has cleared its investigational new drug (IND) application for GZR4, to improve the management of diabetes. GZR4, a new generation of once-weekly ultra-long-acting insulin, is expected to be dosed once a week by subcutaneous injection in humans to achieve smooth control of basal blood glucose for one week.

Insulin analogs are extremely important in the treatment of diabetes. However, the currently available long-acting insulin analogs in the market are all daily formulations, so patients need to receive the injection every day. Even once-daily subcutaneous self-injection of insulin is a major barrier to intensive therapy for most patients with T2DM, and many patients with T1DM would like to be able to reduce the number of daily insulin injections without compromising glycemic control. Therefore, many companies are investigating the once-weekly long-acting insulin injection, given its features of fewer injections, stable drug effect, and less risk of hypoglycemia. GZR4 from Gan & Lee Pharmaceuticals is the first once-weekly insulin developed by Chinese domestic company and approved by NMPA for IND.

In recent years, Gan & Lee has taken advantage of the R&D of insulin, vigorously enriching insulin products. The company launched second-generation insulin products and many types of third-generation insulin analogs in China. The IND approval of the fourth-generation of insulin product GZR4 may provide Chinese patients an innovative therapy.

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including 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). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.