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On January 26 (Beijing time), Adocia, a biotechnology company focused on the treatment of diabetes and other metabolic diseases, announced positive results of its clinical trial of the ultra-rapid-acting insulin lispro injection (BC Lispro). Adocia used the insulin lispro drug substances supplied by Tonghua Dongbao in this clinical trial. The positive results prove the performance and quality of Tonghua Dongbao’s insulin lispro drug substances and pave the way for the two companies to carry out the phase III clinical trial in China and the worldwide market.

Back in 2018, Adocia formed a strategic alliance with Tonghua Dongbao to develop and commercialize BC Lispro in China and other Asian territories. Tonghua Dongbao also supplies insulin lispro and insulin glargine drug substances to Adocia for the worldwide market.

Previous clinical studies of Adocia demonstrated the faster onset of action and improved glycemic control of BC Lispro, prepared from the insulin lispro drug substances of Eli Lilly and Company, compared to Humalog, Novolog, and Fiasp. BC Lispro also showed great safety and tolerability.

To advance the phase III clinical trial that studies the BC Lispro prepared from Tonghua Dongbao’s insulin lispro drug substances in Europe and the US, Adocia designed this clinical trial and obtained approvals from the German regulator and the US FDA in July 2020 successively.

This randomized, crossover, double-blind glucose clamp study was conducted in 30 patients with type 1 diabetes. It evaluated and compared the pharmacodynamic and pharmacokinetic profiles and safety of four formulations, i.e., BC Lispro based on the patented BioChaperone excipient and Tonghua Dongbao’s insulin lispro drug substances, BC Lispro based on the patented BioChaperone excipient and Eli Lilly and Company’s insulin lispro drug substances, Humalog (Eli Lilly and Company) approved in the US, and Humalog (Eli Lilly and Company) approved in Europe.

The results showed that the BC Lispro based on Tonghua Dongbao’s insulin lispro drug substances demonstrated faster absorption and onset of action with good safety and tolerability than Humalog approved in the US and Europe. In addition, BC Lispro based on Tonghua Dongbao’s insulin lispro drug substances showed similar pharmacodynamic and pharmacokinetic profiles with the BC Lispro prepared from Eli Lilly and Company’s insulin lispro drug substances, which suggests that data from the previous clinical studies can be bridged.

Olivier Soula, Deputy CEO and R&D Director of Adocia, said this study was an important milestone for Adocia in BC Lispro development, paving the way for the phase III clinical trial in Europe and the US.

Mr. Leng Chunsheng, Chairman of Tonghua Dongbao, said that the positive clinical trial results are of great value to both parties, and will play a positive role in advancing the phase III clinical trial of BC Lispro, which has already got the NMPA approval, in China. Going forward, Tonghua Dongbao will double down on drug R&D and further enrich its product portfolios to be an explorer and leader of novel drugs R&D in the field of endocrinology.