Development of generic drugs is an important goal for the Rissian Federation, since many of the currently used and effective medications for treatment of socially significant diseases have been developed and manufactured abroad. Although these drugs are registered in Russia, their high prices remains an obstacle for their wide use, resulting in insufficient purchasing by the country and limited supply to the patients.
Currently, Russian health care system is strongly dependent on importing drugs for treatment of many serious medical conditions, like cancer and rare genetic diseases. Unfortunately, drug import is highly dependent on the market conditions, which is unacceptable for the country from a strategic point of view. As a result, many patients with life-threatening health conditions, such as cardiovascular, oncologic, autoimmune and others, are treated with suboptimal, outdated, ineffective or unsafe medical products.
Establishment of a manufacturing facility for generic drugs in Russia is not an easy task, as it requires the availability of a full cycle research and development infrastructure, starting from the pre-clinical stage all the way to the product marketing. However, our Holding has successfully achieved this goal.
At the same time, development of improved biopharmaceuticals, and especially the innovative medical products, is a much more ambitious goal. However, the real challenge here is to bring together a team of highly qualified professionals, cutting-edge science and state-of-the-art technology for the success of the project. Now we are confident that the International Biotechnology Center “Generium” (“IBC “Generium”), established within the Holding, is capable of successfully achieving these goals.
Improved and innovative medical products can dramatically reduce the death rate in Russian Federation by opening new opportunities for treatment of serious and rare diseases, for which treatment either did not exist, was not effective or safe enough.
Development of innovative, first-in-class therapeutics is associated with huge financial risks and long term investments, but the results justify the means. Such therapeutics will not only broaden the repertoire of treatable medical conditions and improve people’ s lives; they will also strengthen the position of Russia on the international pharmaceutical market, and will present a serious commercial success.
Manufacturing technology has been developed, clinical studies have been done and currently the following medicinal products are on the Russian market: Diaskintest®, Infibeta®, Coagil® VII, Octofactor®, Innonafactor®, Filgrastim substance and Somatropin substance.
For another three therapeutics manufacturing technology has been developed and clinical studies are ongoing: Reveliza®, Apagin®, Glurazim®.
Manufacturing technology has been developed and clinical trial application has been submitted for Deplera®.
Currently 9 medicinal products are at the preclinical phase with 4 of them being innovative.
Another 10 innovative biologics for various cancers including B-cell lymphomas (non-Hodgkin’s lymphomas) and other tumors (metastasizing as well) are under development.
In 2012 our Holding has launched several productive research collaborations with leading biotech companies abroad, focused on development and implementation of innovative therapeutic cell-based technologies. These technologies and cell-derived products will provide patients in the Russian Federation with the advanced and affordable methods of treating a number of debilitating diseases.
Status of product development:
|Allergic diseases||GNR-044||Protein based Biosimilar||R&D stage|
|Autoimmune diseases||GNR-042||Protein based Biosimilar||Preclinical trials in vivo|
|GNR-045||Protein based Biosimilar||Preclinical trials in vivo|
|Cardiovascular diseases||GNR-004||Protein based Biosimilar||Phase III clinical studies|
|Congenital diseases||GNR-001||Protein based Biosimilar||Registered|
|GNR-002||Protein based Biosimilar||Registered|
|GNR-003||Protein based Biosimilar||Registered|
|GNR-008||Protein based Biosimilar||Phase I clinical studies|
|GNR-021||Protein based Innovative||Preclinical trials in vivo|
|GNR-039||Protein based Biosimilar||Preclinical trials in vivo|
|Infectious diseases||GNR-007||Protein based Biosimilar||Preclinical trials in vivo|
|Oncology||GNR-006||Protein based Biosimilar||Clinical trial permission has been granted|
|GNR-011||Protein based Innovative||Phase II-III clinical studies|
|GNR-022||Protein based Innovative||Preclinical trials in vivo|
|GNR-027||Protein based Biosimilar||Preclinical trials in vivo|