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Tonghua Dongbao Doses the First Patient in Phase III Clinical Trials of Insulin Degludec/Liraglutide Injection
Date：2025-03-20
Author：東寶
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Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or "the Company") has completed the Phase I clinical trial in China for Insulin Degludec/Liraglutide Injection following the receipt of a clinical trial approval notification from the National Medical Products Administration (NMPA). The results show that the insulin degludec/liraglutide injection developed by the Company has good safety and tolerance, and exhibits pharmacokinetic bioequivalence to the control drug, Xultophy?. The Company subsequently initiated a Phase III clinical trial in China and has recently completed dosing of the first subject.
The Insulin Degludec/Liraglutide Injection has demonstrated good clinical efficacy and safety, and has been included in the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition). The drug promises great growth potential. The original innovator product, marketed as Xultophy/諾和益? by Novo Nordisk, was first approved by the European Medicines Agency (EMA) in September 2014 for treating adult Type 2 diabetes, before receiving approval from the U.S. Food and Drug Administration (FDA) in November 2016, and from China's NMPA in October 2021. According to recent financial reports from Novo Nordisk, sales of Xultophy? in China (including mainland China, Hong Kong, and Taiwan) surged from RMB 45 million in 2022 to 1.43 billion in 2024, with a compound annual growth rate (CAGR) of approximately 463%, showing a rapid market expansion trend. To date, no biosimilar to insulin degludec/liraglutide injection has been submitted for marketing approval in China. The Company is currently among the front-runners in this area.
Focusing on GLP-1 receptor agonists, Tonghua Dongbao has built a diversified product and pipeline portfolio covering multiple targets, indications, and dosage forms. This includes liraglutide, insulin degludec/liraglutide injection, semaglutide, a dual GLP-1/GIP receptor agonist (THDBH120 injection), and an oral small-molecule GLP-1 receptor agonist (THDBH110 capsules), aiming to meet a wide range of clinical treatment needs. Looking ahead, the Company will remain focused on new product development and will continue to improve innovation efficiency, further strengthening its competitiveness and innovation capacity in the biopharmaceutical industry while creating greater value for society and shareholders.
About Phase III Clinical Trials of Insulin Degludec/Liraglutide Injection
Recently, the Company launched a 26-week, randomized, open-label, multicenter, positive-controlled, parallel-group Phase III clinical study in Chinese adults with type 2 diabetes. The study is designed to compare the efficacy and safety of the Company's insulin degludec/liraglutide injection with Xultophy? under once-daily subcutaneous administration. The goal is to demonstrate clinical similarity in efficacy and safety between the two treatments.
About Insulin Degludec/Liraglutide Injection
The insulin Degludec/Liraglutide injection, originally developed by Novo Nordisk in Denmark, is a combination of a basal insulin analog and a GLP-1 analog and is the first of its kind in the global market. The two components complement each other, targeting multiple pathophysiological defects for the treatment of type 2 diabetes and regulating glucose homeostasis.
The drug can be administered at any time of the day to enhance medication adherence. After subcutaneous injection, its two components retain their respective pharmacokinetic properties, complementing each other without interference. At the same or lower dosage, Insulin Degludec/Liraglutide Injection results in greater glucose reduction and better hemoglobin A1c (HbA1c) control compared to basal insulin alone, while also reducing the risk of hypoglycemia and preventing weight gain. The Insulin Degludec/Liraglutide Injection has demonstrated good clinical efficacy and safety, and has been included in the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition). The drug promises great growth potential.
