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  • The «Medsintez» plant carries on implementation of the large-scale ‘Import-substituting production of genetic engineering and analog insulin from own substance’ project

The «Medsintez» plant carries on implementation of the large-scale ‘Import-substituting production of genetic engineering and analog insulin from own substance’ project

Details
Published: 18 December 2018

Today, the company has a developed technology for obtaining the RosinsulinAspart and RosinsulinGlargin substances as well as their dosage forms.

Clinical trials of finished drugs made of these substances started in 2017 and are still going on. By now, the RosinsulinAspart and RosinsulinGlargin formulations have passed the first clinic phase and the results have shown their full bioequivalence with the original drugs. In accordance with the approval granted by the Ministry of Health, the third-phase clinical trials of RosinsulinAspart have been launched. Also, an application for the third-phase clinical trials of RosinsulinGlargin, the most complex drug, has been submitted. During the third-phase clinical trials, the drugs will be administered to patients with diabetes mellitus to assess tolerance and effectiveness compared to standard treatment methods. A positive test result is expected, since the third-phase trials of the Rosinsulin human genetic engineering insulin have already proven good results in terms of tolerance.

The implementation of the project will allow to give up purchasing foreign substances and create a full-cycle insulin production.

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