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Tonghua Dongbao: BC Lispro is approved for parallel Phase III and Phase I clinical trials
Date：2021-10-12
Author：Dongbao
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On March 28, 2021, Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company” or “Tonghua Dongbao”) submitted to the Center for Drug Evaluation of the National Medical Products Administration (the CDE) an application for Type II meeting on conducting parallel phase III and phase I clinical trials on BC Lispro (THDB0206), an ultra-rapid-acting insulin lispro injection. The application was recently approved by the CDE.
In June and July 2020, Tonghua Dongbao’s partner Adocia was approved by the German BfArM and the US FDA to initiate a phase I PK/PD clinical trial. The trial report was available in January 2021. According to the report, the ultra-rapid-acting insulin lispro injection prepared from Tonghua Dongbao's insulin lispro drug substances boasts faster absorption and onset of action and greater safety and tolerability than Humalog?, an insulin lispro injection approved in the US and Europe.
BC Lispro (THDB0206) is an improved version of the mealtime insulin analog (insulin lispro injection) using a new formulation technology. Early research reveals that, compared with mealtime insulin analogs, insulin lispro injections are absorbed more rapidly after subcutaneous administration, with higher early exposure and similar overall exposure, resulting in a greater, earlier glucose-lowering effect, but a similar overall hypoglycemic activity. The time-exposure and time-effect curves show a "leftward shift", similar to those of Fiasp? and Lyumjev? that have been marketed in foreign countries. This feature conforms to the physiological pattern of insulin secretion.
Defects in early-phase insulin secretion are particularly pronounced in Chinese diabetic patients compared to foreign patients. BC Lispro (THDB0206) is expected to restore early-phase insulin secretion, producing a faster and smoother glucose-lowering effect, while reducing the potential risk of late postprandial hypoglycemia caused by delayed secretion of endogenous insulin and/or delayed absorption of exogenous insulin. It also provides patients with greater convenience and flexibility in insulin injection timing.
BC Lispro is the first ultra-rapid-acting insulin product approved for clinical trials in China. The successful application for parallel clinical trials of BC Lispro offers valuable experience for the Company. If approved for marketing, the product is expected to further enrich and upgrade the Company's diabetes product portfolio. Patients will have more choices due to the Company’s complete product lineup. Meanwhile, the approval can help improve the Company's overall R&D and innovation capabilities, increase its core competitive edge and profitability, and thereby consolidate its lead in diabetes treatment.
Tonghua Dongbao will continue to keep a finger on the pulse of the cutting-edge and key technologies in diabetes and endocrine treatment, in a bid to build a world-class R&D and commercialization platform. Guided by the philosophy of "Establishing a Global Brand Through Consistent Innovation", the Company will vigorously advance technological innovation, inspire talent's creativity, and stick to the innovation-driven development strategy to promote high-quality business growth.
