Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or "the Company") has initiated the Phase I clinical trials in China for Insulin Degludec/Liraglutide Injection following the receipt of a clinical trial approval notification from the National Medical Products Administration (NMPA). Recently, the Company successfully dosed the first patient.

This milestone represents a major step forward in the Company's R&D of GLP-1RA combination drug products for insulin analogs, further enhancing its competitive edge in the treatment of endocrine disorders. Building on its extensive experience in diabetes care and research, Tonghua Dongbao is poised to accelerate the clinical trial process, expedite the process for product approvals, and offer a more diverse and comprehensive portfolio of therapeutic options.

Insulin Degludec/Liraglutide Injection presents enormous market potential and the market is growing rapidly. The original innovator product, marketed as Xultophy/诺和益® 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, which includes the Chinese Mainland, Hong Kong, and Taiwan, surged from RMB 45 million in 2022 to 431 million in 2023. The first quarter of 2024 saw regional sales climb to approximately RMB 332 million, a staggering 602% increase year-on-year.

About Phase I Clinical Trials of Insulin Degludec/Liraglutide Injection

Following approval from the NMPA, Phase I clinical trials have been initiated to perform a pharmacokinetic comparison between our Insulin Degludec/Liraglutide Injection and Novo Nordisk's Xultophy®. This single-dose, randomized, open-label, two-period, crossover study is being conducted on healthy Chinese subjects. The primary goal is to assess the pharmacokinetic similarity between a single subcutaneous injection of our product and Xultophy®. The secondary goal is to evaluate the pharmacokinetic profiles, safety, and tolerance of a single subcutaneous injection of Insulin Degludec/Liraglutide in comparison with Xultophy® among healthy Chinese subjects.

About Insulin Degludec/Liraglutide Injection

The Insulin Degludec/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, 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.