In October 2021, Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company" or "Tonghua Dongbao") received the notice of approval from the National Medical Products Administration (NMPA) for the clinical trial of its ultra-rapid-acting insulin lispro injection, BC Lispro (THDB0206) ("BC Lispro"). The phase III clinical trial has been initiated in China, and the first subject was successfully enrolled the other day.
This will provide a sufficient basis for the Company's application for the registration of BC Lispro. 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.
BC Lispro is a next-generation rapid-acting insulin analog which 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, BC Lispro shows faster subcutaneous absorption, greater 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 Liumjev® that have been marketed in foreign countries. Its action profile closely matches the physiological insulin secretion pattern. Fiasp® and Liumjev® feature faster and better drug absorption, resulting in a faster onset of insulin action, which is closer to the physiological insulin secretion pattern following a meal. Fiasp® and Liumjev® are not yet available in China.
Chinese diabetic patients suffer more serious under-secretion of insulin in the early phase than foreign patients. The Company's BC Lispro is intended to restore the early-phase insulin secretion, resulting in a more rapid and stable glucose-lowering effect. Meanwhile, it can reduce the risk of post-prandial hypoglycemia due to delayed endogenous insulin secretion and/or delayed exogenous insulin absorption. It also provides patients with greater convenience and flexibility in insulin injection timing.
In the future, Tonghua Dongbao will continue accelerating the R&D process and making it more efficient to achieve the speedy launch of high-quality drugs. 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. The Company will also continue pursuing high-quality and innovation-driven growth.