Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") has recently completed a Phase I pivotal clinical trial on the BC Lispro (THDB0206), an ultra-rapid-acting insulin lispro injection, and yielded a clinical trial report, which shows that the trial has met the primary endpoint.

According to the report, compared with Humalog®, BC Lispro (THDB0206), after subcutaneous injection, exhibits significantly faster absorption in pharmacokinetics, higher early absorption, as well as the noticeably faster onset of action and more substantial effect in pharmacodynamics, with good tolerability and safety profiles.

BC Lispro (THDB0206) was previously approved for Phase III clinical trials in patients with type 1 and type 2 diabetes in parallel with this Phase I pivotal clinical trial, which is progressing well. The positive results of this Phase I pivotal clinical trial have reaffirmed the ultra-rapid-acting clinical benefits of BC Lispro (THDB0206) and laid a solid scientific foundation for the Phase III clinical trial.

About the clinical trial

Following the clinical trial approval, the Company initiated the first phase of the "open-label, positive-controlled, randomized, three-phase, crossover trials to evaluate the pharmacokinetics and pharmacodynamics of single-dose injection of BC Lispro (THDB0206) in healthy Chinese subjects." The main objective of this trial was to evaluate whether BC Lispro (THDB0206) boasts faster absorption and onset of action than Humalog®.

About BC Lispro (THDB0206)

BC Lispro (THDB0206) is an improved version of the third-generation 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" compared to those of insulin lispro injections.

The hyposecretion of insulin in the early phase is particularly pronounced in diabetic patients from China compared to those from other countries. BC Lispro is intended to restore the early-phase insulin secretion, producing a faster and more stable 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 a next-generation rapid-acting insulin analog. The only similar drugs available worldwide are Novo Nordisk's Fiasp® and Eli Lilly's Lyumjev®. These insulin analogs feature faster and better drug absorption, resulting in a faster onset of insulin action, similar to the physiological pattern of postprandial insulin secretion. BC Lispro is expected to be the first Chinese-made ultra-rapid-acting insulin analog, since Fiasp® and Lyumjev® are not yet available in China.