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Tonghua Dongbao: Phase I clinical trial application for BC Combo approved in Germany
Date：2022-04-12
Author：東寶
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Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") was approved by the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for the phase I clinical trial of BioChaperone? Combo ("BC Combo"), a soluble insulin glargine/lispro injection (THDB0207 injection) the other day.
The approval will greatly improve the R&D efficiency of BC Combo. The upcoming 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 phase III clinical trials. This marks an R&D milestone for the Company, demonstrating its effort to accelerate its R&D pipeline and its capability to carry out R&D activities on a global scale. It also provides valuable experience for subsequent products to undergo international clinical trials and paves the way for the Company's global expansion.
BC Combo is the only compound preparation that can combine the long-acting insulin glargine and the rapid-acting insulin lispro, which is a leading and unique product available in the market. Combined with new excipients, the soluble insulin glargine and insulin lispro injection can form a stable dual insulin compound preparation at a neutral pH value. 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, it can better control fasting and postprandial blood sugar in a balanced manner. Compared with pre-mixed insulin, it can better control fasting blood sugar, reduce the risk of hypoglycemia caused by the "shoulder effect", and is easier to use.
Deficiency in early postprandial insulin secretion is particularly pronounced in Chinese patients compared to foreign patients. It is typical for Chinese patients with type 2 diabetes to have elevated postprandial blood sugar levels, poor fasting blood sugar control, and a risk of hypoglycemia. However, few of these clinical needs are satisfied. BC Combo is expected to become a more effective, convenient, and safer alternative to the existing pre-mixed insulin products, expanding treatment options for Chinese patients.
The dual insulin market is lucrative. According to information published on Novo Nordisk's official website, Ryzodeg? has seen substantial growth in sales revenue since it was approved in China in 2019. Specifically, Novo Nordisk reported Ryzodeg? sales revenue of about RMB 42 million for 2020 and about RMB 291 million for 2021, signaling a rosy prospect for the dual insulin product. According to IQVIA, sales of insulin degludec and insulin aspart injection in China are expected to rocket to RMB 3 billion by 2025. In the future, the soluble insulin glargine and insulin lispro injection will provide more treatment options for patients and will also advance the development of the Company.
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.
