ADOCIA has expanded its strategic alliance with Tonghua Dongbao Pharmaceuticals to manufacture and supply insulin lispro and insulin glargine APIs to Adocia worldwide, excluding China. Under the Supply Agreements, Tonghua Dongbao will manufacture and supply insulin lispro and insulin glargine APIs to Adocia, in accordance with Adocia’s specifications and quality standards.
 
Tonghua Dongbao has an annual manufacturing capacity of more than three tons of insulin, spread over several manufacturing facilities. While already commercializing human-insulin-based products in China and other markets, Tonghua is also developing multiple insulin analogs, including, insulin glargine which is already filed for commercial approval in China, and insulin lispro, expected to enter Phase III testing. Tonghua Dongbao insulin lispro is manufactured in the same plant as the human insulin used in its currently marketed products; a plant which has passed a cGMP audit enabling Phase III studies in Europe.
 
“We are very pleased to strengthen our strategic alliance with Tonghua Dongbao and enter global supply agreements for insulin lispro and insulin glargine. These agreements give us full control, outside China, over the further development of BioChaperone Lispro, our ultra-rapid insulin, and BioChaperone Combo, our combination of insulins glargine and lispro,” said Gérard Soula, chief executive officer of Adocia. “This also opens additional collaboration opportunities with biopharmaceutical companies focused in diabetes with no existing insulin manufacturing facilities and, also, device companies integrating synergies between innovative medicines, devices and care management systems.”
 
“The high quality of Tonghua Dongbao’s insulins, their state-of-the-art facilities and their large manufacturing capacity were all key elements in our decision to expand our collaboration with these supply agreements,” said Olivier Soula, Deputy General Manager and Director of R&D at Adocia. “Both Companies have defined a clear path towards approval of these insulins by regulated markets authorities and are very confident on its successful implementation. Securing insulin lispro supply is also a significant milestone towards the Phase 3 development of BioChaperone Lispro.”