Beijing, China/Bridgewater, NJ, USA, July 6, 2022 – Gan & Lee Pharmaceutical Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) announced that Gan & Lee's self-developed Class 1.1 new drug GZR101 has initiated Phase I clinical trials and the first subject has been dosed. GZR101 is a premixed dual insulin co-formulation composed of ultra-long-acting insulin GZR33 and fast-acting insulin aspart. This trial is the first-in-human trial (FIH) of GZR101 conducted in China. This trial will evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of GZR101 injection solution and its constituent GZR33 in subjects.

The trial was carried out in the Phase I Clinical Laboratory of the Clinical Trial Research Center, Tianjin Medical University General Hospital, the primary objective of this phase I study is to investigate any variations and abnormalities of GZR101's safety, while the secondary objectives are to determine the pharmacokinetic (PK), pharmacodynamic (PD) parameters, and immunogenicity.

Dr. Wei Chen, Vice President of Research and Development of Gan & Lee Pharmaceuticals, said, "As the country with the largest number of diabetes patients in the world, China has many unmet clinical needs, and Gan & Lee Pharmaceuticals has always focused its R&D strategy on the needs of patients. GZR101 is an important breakthrough in the field of insulin compounding and we expect GZR101 to bring more benefits to patients worldwide."

About GZR101 Injection Solution

The GZR101 injection solution is a premixed dual insulin co-formulation composed of ultra-long-acting basal insulin GZR33 and fast-acting insulin aspart (Rixulin^®). It is expected that GZR101 can simulate the biphasic mode of physiological insulin secretion pattern under the once-daily administration. While considering both fasting and postprandial blood glucose control, GZR101 may have the advantage of stabilizing blood glucose smoothly and improving blood glucose control rate. Additionally, it has the potential to simplify treatment, improve patient compliance, and reduce treatment burden to optimize long-term diabetes management and help reduce or delay the onset of complications.

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.