Good news! The clinical application of TUL Degu Mendong Double Insulin Injection was accepted

On April 15, 2022, the Insulin Degludec and Insulin Aspart Injection developed by The United Bio-Technology (Hengqin) Co., Ltd (hereinafter referred to as "TUL Biotechnology") received a clinical registration application acceptance notice issued by the National Drug Administration, with acceptance number CXSL2200172. This is the first biological product to apply for clinical trials after the establishment of TUL Biotech, and also the second domestic enterprise to apply for this biosimilar, marking TUL's new breakthrough in the field of diabetes drug research and development.

What is the DeGu MenDong double insulin preparation?

The Degu Mendong dual insulin preparation consists of a new generation of ultra long acting basic insulin analogues combined with meal insulin analogues, containing 70% Degu insulin and 30% Mendong insulin. Degu insulin has a long acting time and minimal insulin variability, and can form soluble compound formulations with quick acting insulin analogues. The two insulin components act independently without changing their respective pharmacokinetic characteristics, allowing for safer and more effective control of fasting and postprandial blood sugar. It is an ideal new generation of basic dual insulin preparations for meals.

After subcutaneous injection, DeGu insulin forms soluble polyhexamers at the injection site, and their monomers slowly and continuously dissociate, achieving an ultra long time effect. The aspartic insulin hexamers quickly decompose into monomers that are easily absorbed by circulation, exerting the effect of supplementing insulin during meals. The two components exist in independent and stable soluble forms, without changing the pharmacological properties of each component, while controlling fasting and postprandial blood sugar. Compared to the pre mixed insulin analogues currently used in clinical practice, it can better simulate physiological insulin secretion patterns, and hypoglycemic therapy is safer and more effective, providing a more ideal choice for clinical use.

On the basis of mature production processes for raw materials and preparations of DeGu and InsulinAspart insulin, TUL Bio has developed the production process for DeGu InsulinAspart double insulin preparations. The pharmaceutical and non clinical studies of Degu InsulinAspart insulin preparation developed by the company show that the results of the preparation process, quality study and stability study of Degu asparagus insulin injection show that the product process is feasible, the quality is stable and controllable, and the head to head quality of the original product shows that this product, as a biosimilar, has the same quality, effectiveness and safety as the original product. The pharmacodynamic study of this product shows that there is no significant difference between it and the original drug, which indicates that this product is effective for the treatment of diabetes, and there is no doubt about its safety.

As a biopharmaceutical R&D headquarters company of TUL in Hengqin, TUL Biotech plans to enter the clinical research phase of the development of a number of innovative biopharmaceuticals, and develop new drugs with independent intellectual property rights and innovative generic drugs with strong market competitiveness. At present, the company's biopharmaceutical research and development sector is growing rapidly, and each new drug project is in the stage of clinical application or listing application. In the future, it will continue to strengthen the research and development of innovative drugs and improved new drugs, strengthen international cooperation and exchange and project introduction, actively promote the progress of new drug projects, steadily promote the process of capitalization operation, and realize the leapfrog development of TUL in the field of biomedicine, Achieve the goal of building a domestic first-class biopharmaceutical research and development and service platform within 5 to 8 years.