The Medsintez Plant took part in the Scientific and Practical Conference of Pediatric Endocrinologists of the Sverdlovsk Region

On November 26, 2022, the Medsintez Plant took part in the Scientific and Practical Conference of Pediatric Endocrinologists of the Sverdlovsk Region From Clinical Cases to Innovative Projects, dedicated to the 25th anniversary of the endocrinology department of the Regional Children's Clinical Hospital. Leading experts of Russia in the field of healthcare and endocrinology took part in the conference. At the exhibition of domestic pharmaceutical manufacturers, held within the framework of the conference, the Medsintez Plant presented analogue human insulin preparations Rosinsulin®. Doctors – pediatric endocrinologists and endocrinologists of healthcare organizations of the Sverdlovsk Region, the Ural Federal District and other regions of Russia noted the plant's contribution to the drug safety of the country.

About 2,000 children with diabetes receive medical care in the Sverdlovsk Region, and more than 200 new cases of diabetes in children are detected annually. «According to the data of the State Register of Diabetes Mellitus, as of November 1, 2022, 1875 children under 18 years with various types of diabetes mellitus (DM) are registered in the dispensary at the Regional Center for Pediatric Endocrinology (RCPE), including 1789 with type 1 diabetes, as well as 57 children with prediabetes,» Aleksey Kiyaev, chief freelance pediatric specialist, endocrinologist of the Russian Ministry of Health in the Ural Federal District, said. He also noted that all children from the Sverdlovsk Region with the most severe incurable endocrine pathology received treatment and were observed at the Regional Children's Clinical Hospital (RCCH), on the basis of which the Regional Center for Pediatric Endocrinology has been created since October 2019

A full-cycle biotechnological enterprise Medsintez Plant LLC specializes in the development and production of pharmaceutical products and is one of the first industrial production facilities in Russia for finished dosage forms of genetically engineered human insulin that meet the requirements of GMP EC. For 20 years, the company has been actively involved in the implementation of import substitution programs for medicines in the Russian Federation.

The Medsintez Plant produces finished dosage forms of genetically engineered human insulin Rosinsulin® and analogue human insulins Rosinsulin Aspart R® and Rosinsulin Glargine® based on its own substances. The drugs are produced in the most convenient and familiar dosage forms for consumers – in cartridges, vials and pre-filled syringe pens. The decision of the Ministry of Health of the Russian Federation to add the medicine Rosinsulin Glargine (100 IU/ml) to the State Register of Medicines is expected. An analogue medicine Rosinsulin Glargine 300 Medsintez with a concentration of 300 IU/ml has also been developed.

The use of analogue insulin Rosinsulin Aspart R® in therapy in children diagnosed with type 1 diabetes mellitus during phase III of clinical trial showed high efficacy and safety of the drug: similar results of long-term glycemic control were obtained when compared with soluble human insulin.

A clinical trial using soluble human insulin before meals and Insulin Aspart after meals was conducted in children (20 patients aged 2 to 6 years, for 12 weeks, of which 4 patients were under 4 years of age); and a pharmacokinetic and pharmacodynamic study using a single dose was conducted in children aged 6-12 years and in adolescents aged 13-17 years. The pharmacodynamic profile of Insulin Aspart in children was similar to that in adult patients.
 
The efficacy and safety of Insulin Aspart injected as bolus insulin in combination with Insulin Detemir or Insulin Degludec as basal insulin was studied in two randomized controlled clinical trials up to 12 months in children and adolescents aged 1 to 18 years (712 patients). The trial included 167 children aged 1 to 5, 260 children aged 6 to 11, and 285 children aged 12 to 17 Improvements in HbA1c (glycated hemoglobin) and safety profile were comparable in all age groups.

High-tech Russian production at the Medsintez Plant ensures a world-class level of quality and safety of manufactured medicines. At the same time, domestic production of of insulins from our own substance does not depend on currency exchange rates, which means that it offers favorable prices for finished products in comparison with imported analogues. The Medsintez Plant is ready to meet the annual demand for insulin preparations in Russia by 100%.

The main issues for discussion at the conference of pediatric endocrinologists were current trends in the epidemiology of endocrine diseases in children, new challenges in practical diabetology and the improvement of specialized medical care using remote technologies. Discussion of the clinical experience of personalized diagnostics and treatment of rare endocrinopathies was also important at the conference: endogenous hypercortisolism, adrenal insufficiency, thyropathies, rickets-like diseases, short stature, disorders of sexual development. The specialists also discussed the concept of consistent monitoring of patients with chronic endocrine diseases from the moment of diagnosis during all age periods of life.