(AOF) – Adocia has launched three clinical studies with diabetic patients, in Germany, with its product BC Combo. BC Combo is an innovative combination of rapid-acting insulin Lispro (Humalog) and slow-acting insulin Glargine (Lantus). It offers diabetic patients better regulation of their glycaemia compared to the premix insulins widely used today in the world. These studies, entirely financed by the Chinese industrial group Tonghua Dongbao, will be used for the entry into phase III of BC Combo.
These clinical studies conducted in Germany will feed into the Phase 3 entry application file in China.
BioChaperone Combo targets the premix insulin market, which represents 65% of insulin volumes used in China.
The BioChaperone Combo agreement provides for the payment to Adocia of a maximum amount of 50 million dollars subject to reaching future development milestones and double-digit royalties on sales made by Tonghua Dongbao.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: evaluation of the overall benefit/risk ratio with several thousand patients.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for hospital-university research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.