On June 21, 2022, the Insulin Degludec and InsulinAspart Injection developed by Federal Biotechnology (Zhuhai Hengqin) Co., Ltd. received the "Drug Clinical Trial Approval Notice" (Notice No. 2022LP00990) issued by the National Drug Administration.
This is the first clinical approval document for biological products obtained by UL since the establishment of TUL Biotech in Hengqin Guangdong Macao Deep Cooperation Zone, and also the second enterprise in China to obtain the clinical approval document for biosimilar.
Basic information of drugs
Drug name: Degu InsulinAspart Double Insulin Injection
Dosage form: injection
Specifications: 3ml: 300 units (refill), 3ml: 300 units (pre filled)
Applicant: The United Bio-Technology (Hengqin) Co., Ltd
Acceptance number: CXSL2200172
Registration classification: Therapeutic biological products, category 3.3
The Degu InsulinAspart Double 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% InsulinAspart insulin. Regardless of whether in the formulation or after subcutaneous injection, the two components of Degu InsulinAspart Double Insulin exist independently without changing their pharmacokinetic characteristics, which can more safely and effectively control fasting and postprandial blood sugar. It is an ideal new generation of basic meal time dual insulin formulations. 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. DeGu InsulinAspart double insulin is injected once or twice a day with the main meal. Compared to pre mixed human insulin, it does not need to be well mixed before injection and there is no need to wait for meals after injection. The conversion from premixed human insulin to dual insulin therapy with DeGu InsulinAspart can further achieve therapeutic and safety benefits.
On the basis of mature production processes for raw materials and preparations of DeGu insulin and aspartame insulin, the DeGu aspartame double insulin preparation production process has been developed by the DeGu aspartame project team of TUL Biotech Company. After the project was approved in 2018, research began on the pharmaceutical part. After prescription research and process screening, the prescription process of Degu InsulinAspart Double Insulin Injection was determined. In 2019, three batches of clinical samples of Degu InsulinAspart Double Insulin Injection were completed for pilot production. The preparation process, production scale, production equipment, and product quality of the three batches of samples can represent the production of clinical trial samples, which has a certain degree of production continuity and scalability feasibility. The project team has conducted a comprehensive quality similarity study on the self developed drug and the original reference drug of Degu InsulinAspart Double insulin injection in many batches from aspects of mo...
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