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Tonghua Dongbao: BC Combo meets primary endpoint in phase I clinical trial in Germany
Date：2023-10-24
Author：東寶
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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") completed three key phase I clinical trials of BC Combo (THDB0207), a soluble insulin glargine and insulin lispro injection, and generated the clinical study reports. The primary endpoints were met in the studies.
Compared with single insulin components, THDB0207 is a unique and effective formulation with a PK profile typical of mixed insulin preparations and is indicated to improve both fasting and postprandial glucose control. The PK-PD analysis shows that during mealtime, compared to mixed protamine zinc recombinant human insulin lispro injection 25R, THDB0207 has higher early exposure and lower late exposure, which may reduce the risk of late postprandial hypoglycemia. During the basal phase, 12 hours after administration, THDB0207 still had a higher exposure and stronger pharmacodynamic response that lasted 30 hours after dosing, indicating its potential to enhance fasting glucose control. The overall evaluation demonstrates that THDB0207 has a good benefit-risk ratio, which supports further clinical development in the next phase.
About the clinical trial
Upon receiving German BfArM approval for BC Combo clinical trials, the Company initiated three phase I clinical trials (CT046, CT047, and CT048) in May 2022 to evaluate the clinical pharmacology of the drug.
About THDB0207 Injection
BC Combo is the only co-formulation that can combine the long-acting insulin glargine and the rapid-acting insulin lispro. Utilizing new excipients, THDB0207 Injection is a stable neutral-pH co-formulation of insulin lispro and insulin glargine.
At present, the only dual-insulin product in the world is Ryzodeg? (insulin degludec and insulin aspart injection) from Novo Nordisk. Ryzodeg? has been launched in many countries and regions such as Japan, Europe, and the United States since 2012. It was approved for marketing in China in May 2019. At present, the only dual-insulin product in China is Ryzodeg? (insulin degludec and insulin aspart injection).
The market size of dual-insulin injections continues to expand. According to information published on Novo Nordisk's website, Ryzodeg? has seen substantial growth in sales revenue since it was approved in China in 2019. Specifically, Novo Nordisk reported sales revenue of about RMB 42 million from Ryzodeg? for 2020, about RMB 275 million for 2021, and about RMB 1.21 billion for 2022. According to IQVIA, sales of insulin degludec and insulin aspart injections in China are expected to rocket to RMB 3 billion by 2025.
As a veteran player in China's diabetes treatment market, the Company boasts the broadest portfolio of products on offer and under development, including 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, which can meet the needs of different diabetic patients in the market. The market for our products will continue to expand. Going forward, the Company will continue to launch quality products to achieve high-quality development and maintain its lead in the industry.
