NANOLEK has submitted documents to receive marketing authorizaton for BRUKINSA in the Russian Federation as a treatment for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
BRUKINSA (zanubrutinib) is currently approved in the United States and China for the treatment of certain patients with mantle cell lymphoma.
“In NANOLEK we have found a distribution partner who we believe can professionally promote BRUKINSA (zanubrutinib) in Russia and across the EAEU. We value NANOLEK’s experience in working with global biotechnology companies and its particular expertise in promoting specialty care medicines. We are excited to work with NANOLEK in reaching our goal of developing and delivering impactful medicines that will be accessible to far more cancer patients around the world,” said Todd Yancey, M.D., SVP of Global Medical Affairs & New Market Development at BeiGene.
“Cancer diagnoses just keep on growing, but the number of people who get into remission and overcome this disease is growing as well. We are witnessing new generation drugs entering the market and providing treatment with fewer side effects. We are glad that BeiGene has entrusted us with its new product and we look forward to it soon becoming available to Russian patients. On the tenth anniversary of our company, this partnership is becoming even more important to us as in addition vaccines, we actively develop oncology segment”, said Vladimir Khristenko, President of NANOLEK.
Stanislav Naumov, Chairman of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union: “For most people, cancer is one of the most terrifying words of all. We are pleased to know that the state has made this a priority issue: the nationwide program “Fight Against Cancer“ is implemented as part of the National Healthcare Project and targeted at reducing the mortality rate from malignant neoplasms. On the other hand, members of our association are paying particular attention to the treatment of cancer. Collaboration between such innovative companies as BeiGene and NANOLEK represents one more step forward in the treatment of this disease, will increase the patient survival rate, and help overcome a popular opinion on cancer as a terrible and incurable disease.”
Background information
BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists, that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Mantle cell lymphoma is a B-cell lymphoma that develops from malignant B-lymphocytes of the immune system. It belongs to a group of diseases known as non-Hodgkin’s lymphomas. This type of lymphoma is characterized by a particularly aggressive behaviour, short time to progression, and chemoresistance during relapse. Most patients are diagnosed in the advanced stage of the disease.
BRUKINSA is approved in the United States as a treatment for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
BRUKINSA has received conditional approval from the in China NMPA for the treatment of MCL in adult patients who have received at least one prior therapy and for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy. Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
Currently, more than 20 marketing applications for BRUKINSA have been submitted covering 45 countries and regions globally, including the United States, China, and European Union.
The estimated incidence rate in the Russian Federation is about 1,030 new cases of mantle cell lymphoma per year.
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.