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Tonghua Dongbao becomes the first Chinese manufacturer to have its clinical trial application for insulin degludec and liraglutide injection accepted
Date：2022-08-30
Author：東寶
Views：3
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter "Tonghua Dongbao" or "the Company") received the notification of acceptance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on the clinical trial application for insulin degludec and liraglutide injection. The acceptance number is CXSL2200411 Guo.
The insulin degludec and liraglutide injection, a combination of a basal insulin analog and a GLP-1 analog, is the first of its kind in the global market. The two components complement each other, working on multiple pathophysiological targets for the treatment of type 2 diabetes. Tonghua Dongbao is the first company other than the original drug developer to submit the registration application for insulin degludec and liraglutide injection. With its clinical trial application accepted, the insulin degludec and liraglutide injection is expected to be a new choice for patents and inject new momentum into the Company's business growth.
The drug can be administered at any time of the day, helping improve medication adherence. Its two components will maintain their respective pharmacokinetic properties, not interfering with each other, after subcutaneous injection. At the same or lower dose, the drug can result in a greater glucose reduction and better control of HbA1c level than basal insulin. It can also mitigate the risk of hypoglycemia and prevent weight gain. The insulin degludec and liraglutide injection has been included in the China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition).
The insulin degludec and liraglutide injection has great market potential. The brand-name drug (Xultophy) was approved by the European Commission in September 2014 for the treatment of adults with type 2 diabetes, and was approved for marketing by the FDA in November 2016. It entered the Chinese market in October 2021 and recorded a sales revenue of approximately RMB 19.79 million in the first half of 2022. The product is still in its early rollout stage.
As a veteran player in China's diabetes treatment market, the Company boasts the broadest portfolio, serving to meet the medication needs of patients of different stages and characteristics. With a stream of new products to be approved for marketing, the Company will constantly expand its market to achieve sustainable development and maintain its lead in the industry.
