Adocia announced that its partner Tonghua Dongbao releases positive topline results on the second Phase 3 clinical trial on BioChaperone Lispro (THDB0206 injection), a novel Ultra-Rapid Insulin formulation. Conducted by Tonghua Dongbao, this Phase 3 study was approved by the Chinese Regulatory Authorities (CDE1). The randomized, open, multicenter study evaluated the safety and efficacy of THDB0206 injection compared to Humalog in adults with Type 1 Diabetes. Tonghua Dongbao currently employs over 3,000 people and has sales of around $280 million. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of about $2.3 billion. Results
A total of 550 Chinese adults with Type 1 diabetes with inadequate glycemic control and using daily multiple injections of insulin were randomized. After 26 weeks of treatment, HbA1c decreased significantly in both groups compared to the baseline. The reduction in the THDB0206 injection group was comparable to that of the Humalog® group, meeting the primary endpoint. The first key secondary endpoint was also demonstrated, with a statistically significant lower rise of blood glucose after a standard meal for the THDB0206 injection group, compared to the Humalo group. In addition, the study shows a significant trend of blood glucose improvement 2 hours after a standard meal for the THDB0206 injection group, compared to the Humalo group. The 10-point self-monitoring blood glucose (SMBG) of patients at week 26, an important supportive endpoint of the trial, confirmed the advantage of this product in controlling postprandial blood glucose, with a statistical improvement 1 hour after each meal (breakfast, lunch, dinner). In addition, the safety and tolerability of THDB0206 injection were good. Most of the adverse events were mild or moderate, and the incidence of adverse events and hypoglycemic events were similar to those of Humalo. Those results confirm the positive results obtained with THDB0206 injection in people with Type 2 Diabetes, as communicated in July 2025.
TONGHUA DONGBAO PHARMACEUTICAL CO., LTD. is a China-based company, principally engaged in the research and development, manufacture and distribution of pharmaceuticals. The Company provides biological products, traditional Chinese medicines and chemical supplements, applied in the treatment of diabetes and cardiovascular and cerebrovascular diseases, among others. The Company's main products portfolio consists of recombinant human insulin bulk drugs and injections, zhennaoning capsules, among others. The Company also provides medical instruments, plastic-steel windows and profiles, and operates property business. The Company distributes its products within domestic markets and to overseas markets.
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