Mabion on 28 January announced that its partner Laboratorio LKM has filed a preliminary version of the registration dossier of its MabionCD20 drug with the Ministry of Health of Argentina.
The dossier does not include clinical study reports as Mabion is still carrying out Phase III trials of the drug in Europe, but the move should speed up the approval procedure by even up to several months by allowing the Argentine ministry to examine the remaining modules early, CEO Maciej Wieczorek told Parkiet. According to Mr Wieczorek, the Phase III trials of MabionCD20 can be said to be nearing completion. As he explained, Argentina is the latest country where the company initiated the registration process, in line with its strategy to introduce the drug initially in less regulated markets.
Mabion’s partnership agreement with Laboratorio LKM covers eight other countries in Latin America, namely Venezuela, Peru, Chile, Uruguay, Ecuador, Colombia, Bolivia, and Paraguay.