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Tonghua Dongbao: First subject enrolled in phase I clinical trial of BC Combo in Germany
Date：2022-05-19
Author：東寶
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In April 2022, Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company" or "Tonghua Dongbao") received the notice of approval from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, for the phase I clinical trial of its soluble insulin glargine and insulin lispro injection, BC Combo (THDB0207 Injection). The phase I clinical trial has been initiated in Germany, and the first subject was successfully enrolled in the CT046-ADO05 trial the other day.
The phase I clinical trial will enable the Company to obtain data about BC Combo through glucose clamp studies conducted as per world-class technical standards, and hence accelerate the early clinical pharmacology studies in support of the phase III clinical trial. It will also provide valuable experience for the Company to apply for and conduct international clinical trials of more products in the future. If approved for marketing, this product, together with the Company's existing products, will form a comprehensive portfolio of diabetes drugs, which will further enhance the Company's core competitiveness and consolidate its leading position in the diabetes treatment field.
Utilizing new excipients, BC Combo is a stable neutral-pH co-formulation of insulin lispro and insulin glargine. It shows a rapid and efficacious onset of action in the prandial phase, little superposition in the transition phase, and long-lasting effects in the basal phase in terms of pharmacokinetics and pharmacodynamics. Compared with basal insulin, a dual-insulin treatment is expected to control fasting and postprandial blood sugar levels in a balanced manner. Compared with pre-mixed insulin, it can better control fasting blood sugar levels, reduce the risk of hypoglycemia caused by the "shoulder effect", and is easier to use.
BC Combo is the only co-formulation that can combine the long-acting insulin glargine and the rapid-acting insulin lispro. 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. 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 221 million for Q1 2022, signaling a rosy prospect for the dual-insulin product. According to IQVIA, sales of insulin degludec and insulin aspart injections in China are expected to rocket to RMB 3 billion by 2025.
Going forward, Tonghua Dongbao will further expand its R&D pipeline for the treatment of endocrine and metabolic disorders, and adapt to the needs of diverse patients with a multi-level product portfolio. It will continue improving its R&D efficiency and quality to turn itself into an innovative pharmaceutical company as soon as possible. Meanwhile, it will build up its presence in overseas markets and improve its competitive edge on all fronts to continuously enhance its corporate value.
