LYON, France--(BUSINESS WIRE)--Regulatory News:
ADOCIA (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC) and Tonghua Dongbao Pharmaceuticals (Shanghai Stock Exchange 600867) announced today an expansion of their strategic alliance with Tonghua Dongbao to manufacture and supply insulin lispro and insulin glargine APIs to Adocia worldwide, excluding China.
“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, CEO 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.”
As the local leader in the Chinese insulin market, Tonghua Dongbao has an annual manufacturing capacity of more than three tons of insulin, spread over several state-of-the-art manufacturing facilities. While already commercializing human-insulin-based products in China and other markets, Tonghua Dongbao is also developing multiple insulin analogs. Notably, insulin glargine is already filed for commercial approval in China, and insulin lispro is expected to enter Phase 3 testing there. 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 3 studies of Tonghua Dongbao human insulin in Europe.
“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.”
Under the terms of the Supply Agreements, Tonghua Dongbao will manufacture and supply insulin lispro and insulin glargine APIs to Adocia, in accordance with Adocia’s specifications and established quality standards.
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins and peptides. Adocia’s portfolio of injectable treatments for diabetes, featuring six clinical-stage products and two preclinical products, is among the largest and most differentiated of the industry. Adocia also recently expanded its portfolio to develop treatments for obesity and short bowel syndrome.
The proprietary BioChaperone® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone to each protein for a given application to address specific patient needs.
Adocia’s clinical pipeline includes four novel insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone Lispro U100 and U200), a combination of basal insulin glargine and rapid-acting insulin lispro (BioChaperone Combo), a rapid-acting formulation of human insulin (HinsBet U100), and a prandial combination of human insulin with amylin analog pramlintide (BioChaperone Pramlintide Insulin). An aqueous formulation of human glucagon (BioChaperone Human Glucagon) successfully completed a Phase 1 trial. Adocia also develops two combinations of insulin glargine with GLP-1 receptor agonists (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide), a ready-to-use aqueous formulation of teduglutide (BioChaperone Teduglutide) and a ready-to-use combination of glucagon and GLP-1 RA (BioChaperone Glucagon GLP-1), all of which are in preclinical development.
Adocia aims to deliver “Innovative medicine for everyone, everywhere.”
To learn more about Adocia, please visit us at www.adocia.com
About Tonghua Dongbao Pharmaceuticals
Tonghua Dongbao Pharmaceutical co., Ltd. is a China-based company with over 2,000 employees, 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 produces 10 different types of products with over 100 specific pharmaceutical products in production. The Company's main products portfolio consists of recombinant human insulin crystal API, regular recombinant human insulin injection Gansulin R, isophane protamine recombinant human insulin injection Gansulin N, 30/70 mixture recombinant human insulin injection Gansulin 30R, 50/50 mixture recombinant human insulin injection Gansulin 50R, 40/60 mixture recombinant human insulin injection Gansulin 40R, Zhen Nao Ning capsules and Dongbao Gantai tablets, among others. The Company also provides medical instruments. The Company distributes its products within domestic markets and to overseas markets.
This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the “Risk Factors” section of the Reference Document filed with the French Autorité des marchés financiers on April 19, 2018 (a copy of which is available on www.adocia.com) and to the development of economic conditions, financial markets and the markets in which Adocia operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not currently considered material by Adocia. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Adocia to be materially different from such forward-looking statements.
This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia shares in any jurisdiction.