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Tonghua Dongbao: Clinical trial application for insulin degludec injection approved
Date：2022-09-21
Author：東寶
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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter "Tonghua Dongbao" or "the Company") received the notification of approval (No. 2022LP01532 and No. 2022LP01538) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on the clinical trial application for insulin degludec injection. The acceptance numbers are CXSL2200318 Guo and CXSL2200319 Guo.
Insulin degludec is an ultra-long-acting basal insulin analog with a long half-life that can work smoothly and result in lower risk of hypoglycemia. The brand name drug is Tresiba? developed by Novo Nordisk, which was first approved for marketing in Japan in October 2012, and then entered Europe and the US in 2012 and 2015, respectively. In September 2017, insulin degludec injection was approved by the Chinese National Medical Products Administration (NMPA) for the treatment of type 2 diabetes in China. So far, there are no biosimilars of insulin degludec in the global market.
Insulin degludec differs from human insulin in that the threonine at position B30 has been eliminated and a fatty acid chain has been attached to lysine at B29. It presents as a hexamer and can reversibly bind to albumin in plasma to extend its half-life. According to the China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition), insulin degludec has a half-life of 25 hours and can act for 42 hours per injection.
On the whole, insulin degludec is highly effective, safe, cost-effective, and convenient for administration, with a smooth glucose-lowering effect. Clinical studies show that insulin degludec can effectively control the TIR level in patients with type 2 diabetes, which means it has greater clinical significance than insulin glargine. Moreover, as ultra-long-acting basal insulin, insulin degludec can improve medication adherence.
In recent years, insulin degludec has played an increasingly important role in diabetes treatment, and the market is expanding rapidly. According to the IDF Diabetes Atlas 10th edition, there were 537 million adults aged 20-79 years with diabetes worldwide in 2021. Currently, China still has the largest number of diabetic patients, with 140 million adults aged 20-79 living with diabetes in 2021. Novo Nordisk's insulin degludec injection (Tresiba?) achieved global sales of DKK 9.729 billion (about RMB 9.447 billion) in 2021. Specifically, the sales in China hit DKK 1.095 billion (about RMB 1.063 billion), up about 155% year-on-year.
As a veteran player in China's diabetes treatment market, the Company strives to create a comprehensive product portfolio. Its products on offer and under development include long-acting, intermediate-acting, rapid-acting, and ultra-rapid-acting insulins, dual insulin compound preparations, GLP-1RA, long-acting GLP-1RA, insulin analog and GLP-1RA co-formulations, and multi-target Class 1 novel drugs. The approval of clinical trials on insulin degludec marks a major progress in the drug's R&D. To be a new choice for patients, it will drive the Company's future growth and consolidate its lead in the industry.
