New developments! TUL approved the clinical application of Semaglutide injection

On October 24th, The United Bio-Technology (Hengqin) Co., Ltd obtained the "Drug Clinical Trial Approval Notice" issued by the National Drug Administration for its clinical application of Semaglutide Injection. This is the second clinical approval document for biological products obtained by TUL since the establishment of TUL Biotech in Hengqin Guangdong Macao Deep Cooperation Zone just one year ago.

Basic information of drugs

Drug name: Smeglutide injection

Dosage form: injection

Applicant: The United Bio-Technology (Hengqin) Co., Ltd, Zhuhai United Laboratories Co., Ltd., Zhuhai United Laboratories (Zhongshan) Company.

Acceptance number: CXSL2200379

Registration classification: Therapeutic biological products, category 3.3

Indications: This product is applicable to the blood sugar control of adult type 2 diabetes patients: on the basis of diet control and exercise, adult type 2 diabetes patients who still have poor blood sugar control after receiving metformin and/or sulfonylurea drugs.

Smeglutide injection is a long-acting glucagon like peptide-1 (GLP-1) receptor agonist, which has 94% sequence homology with human GLP-1. It is clinically mainly used for blood glucose control in patients with type 2 diabetes, and is also approved abroad for the treatment of obese or overweight patients. Currently, it has been approved for listing in 79 countries/regions such as China, the United States, Europe, Canada, and Japan. This drug only needs to be injected once a week, overcoming the complexity of most medication regimens and effectively improving patients' treatment compliance.

The Semaglutide Project of TUL took only 60 working days from the time it applied for clinical registration to the State Drug Administration in the middle of August this year, which could not be separated from the fact that Liu Hedong, the project leader, led the whole team to work together to tackle the "bone gnawing" problem, seize the second and "seize the time", adhere to a high standard and strict working attitude, and solidly carry out various research work. R&D personnel have worked together to climb the pinnacle and made breakthroughs in multiple key technical fields such as recombinant bacterial expression systems, prescription technology research, and quality comparability research. They have completed the clinical application work of the project with quality and quantity assurance.

TUL has been deeply engaged in the field of diabetes medicine for more than 20 years. From human insulin, insulin glargine, and insulin aspart that have already been listed to Lilalutide, and Degu insulin that are about to submit listing applications to the National Drug Administration, the market share of diabetes listed drugs and the research and development speed of new varieties of the company have always remained at the forefront of similar enterprises in China. From the establishment of the Institute of Biology in 2002 to the establishment of The United Bio-Technology (Hengqin) Co., Ltd and Zhuhai United Laboratories Co., Ltd. in 2021, TUL has continued to grow in the field of biomedicine. Now, it has established a complete product pipeline for the development of diabetes biomedicine, and has a high-level, high standard and high-quality R&D and production team.

The approval of the clinical trial of Smeglutide injection will further enrich the company's product layout in the field of diabetes treatment and GLP-1 target, enhance the company's core competitiveness, accelerate the company's strategic layout in the field of chronic diseases, and meet customers' health needs.