Obtaining a market authorization for this drug is one of the most important steps in the cooperation between NANOLEK and mAbxience (a global fully-fledged biotech company, with over a decade of experience in the development, manufacture and commercialization of biopharmaceuticals). The process of transferring the local production will make it possible to offer a Russian-made medicine to Russian patients.
Rituximab is a chimeric mouse/human anti-CD20+ lymphoma monoclonal antibody. Rituximab specifically binds to the CD20 transmembrane antigen located on pre-B-lymphocytes and mature B-lymphocytes. Mechanism for Rituximab to function is effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells. Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
The level of circulating CD20+ B-lymphocytes decreases in both lymphoma and normal lymphocytes.
The indications for the use of Rituximab are recurrent or chemoresistant B-cell, CD 20-positive non-Hodgkin’s lymphoma with low malignancy or follicularity; follicular lymphoma stage III-IV combined with chemotherapy in patients previously untreated; follicular lymphoma as maintenance therapy after the response to induction therapy; CD 20-positive diffuse B-cell non-Hodgkin’s lymphoma combined with CHOP chemotherapy; chronic lympholeukemia combined with chemotherapy in patients who have not received standard therapy before, and recurrent or chemoresistant chronic lympholeukemia combined with chemotherapy.
Vladimir Khristenko, President of NANOLEK:
“NANOLEK develops its business in three key areas: vaccines, specialty care, contract manufacturing. Issuance of a market authorization for INN Rituximab and adding new drugs to the cancer portfolio is an important milestone not only for the company. Nanolek team has done a great job in helping even more patients to get access to high-quality and state-of-the-art therapy in the Russian Federation.”
ABOUT THE NANOLEK COMPANY
Nanolek is a modern, fast-growing Russian biopharmaceutical company with own high-tech full-cycle production according to GMP and ISO standards, which specializes in the production of import-substituting and innovative medications, both of its own form and those created with the involvement of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique technology transfer expertise in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.).
Today, the company is one of the leaders in the production of pediatric vaccines in the Russian Federation. The NANOLEK company operates in the following areas: vaccines, specialty care, CMO.
Nanolek LLC became the winner of the Platinum Ounce-2019 Award, in the Vector of the Year nomination, as part of the Project of the Year & Business Project sub-nomination. A laureate of the prize in the field of effective use of advanced technologies PRIORITY-2020 in the Localization of Production nomination for HANTERAZA medicine intended to treat Hunter’s Syndrome. Nanolek took first place in the Fast-growing Large Companies Category of the TEKHUSPEKH-2020 Rating. It was also a participant in the priority project of the Ministry of Economic Development of Russia Support for Private High-tech Companies-leaders (National Champions) in 2017.
On August 14, 2019, Nanolek LLC left the list of RUSNANO portfolio companies.
In 2020, Nanolek LLC was included in the list of backbone enterprises of the Russian economy.
The decision to include the organization in the list was made by the government commission to improve the sustainability of the Russian economy’s development. The industry list was published on the website of the Ministry of Industry and Trade of Russia on April 25, 2020.
ABOUT MABXIENCE
mAbxience is a fully integrated global biopharmaceutical company specialising in the development, manufacture and commercialization of monoclonal antibodies, and forms part of the pharmaceutical group Insud Pharma. Founded in 2010, mAbxience operates three state of the art facilities, located in Spain and Argentina. mAbxience is working on several biopharmaceutical products spanning to different therapeutic areas. In 2014 mAbxience launched its first biosimilar, Rituximab (Product Code: RTXM83-MB01), which is now approved and marketed in a range of markets worldwide.
mAbxience is committed to the quality, safety and efficacy of its medicines. The mAbxience team is passionate about patient care and expanding access to its biopharmaceutical medicines all over the world. The Company’s mission is to improve patient access to quality treatments for conditions that require costly medications and positively contributing to the sustainability of healthcare systems.
The Insud Pharma group was founded by Dr. Hugo Sigman and Dr. Silvia Gold and has over 40 years’ experience in the pharmaceutical sector and employs over 6,000 professionals worldwide.