Beijing, China/Bridgewater, New Jersey U.S, September 1, 2022 – Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) today announced the first subject had been dosed in a Phase I clinical trial of GZR4 in China. GZR4 is a novel, ultra-long-acting insulin analog independently developed by Gan & Lee Pharmaceuticals. It has recently obtained clearance issued by the National Medical Products Administration (NMPA)  and the United States FDA has allowed the IND to go forward allowing patients to be treated in the protocol submitted with the IND.

According to the 10th edition of the Diabetes Atlas released by the International Diabetes Federation (IDF), the number of people with diabetes in China has increased to 140 million in the past decade (an increase of 56% over the past). It is estimated that by 2045, the number of people with diabetes in China will exceed 1.75 billion¹. Driven by the rising prevalence and demand for diversified treatment, the domestic and global diabetes market has expanded each year. The company's self-developed Class 1 investigational new product, GZR4, is expected to meet the treatment needs of more patients.

By modifying the molecular structure of human insulin, GZR4 is anticipated will be administered subcutaneously once a week to achieve stable control of basal blood glucose over one week. Preclinical studies have shown that GZR4 has good hypoglycemic effects and safety. The trial is a first-in-human trial (FIH) in China. The primary purpose of this trial is to evaluate the safety and tolerability of GZR4 in human subjects. The secondary objectives include assessing the pharmacodynamic and pharmacokinetic effects of GZR4 in human subjects.

As a fourth-generation ultra-long-acting weekly insulin formulation, GZR4 is expected to achieve once-weekly dosing, reduce the frequency of insulin injections without compromising glycemic control, and improve overall compliance. At the same time, animal studies also show that the drug has stable efficacy and less risk of hypoglycemia, so it is expected to obtain a good overall therapeutic effect in patients." Dr. Chen Wei, the director of Gan & Lee Pharmaceuticals Clinical Department, said: "The successful dosing of the GZR4 is a milestone of this clinical project; hopefully, the product could provide patients with a safe and highly effective treatment option."

Reference：

1. International Diabetes Federation. IDF Diabetes Atlas, 10th ed. Brussels, Belgium: 2021.  Available at: https://www.diabetesatlas.org  

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.