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    NANOLEK
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      NANOLEK
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        NANOLEK
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        History

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        2021

        2021

        NANOLEK ranks first in the Top fast growing companies of the Techuspech-2020 Rating for the second year in a row.

        NANOLEK has stepped up in two categories compared to the 2019 rating results: the Main Rating («Large Companies»), going up from 12th to 6th place, and the «Export Potential» category, going up from 24th to 18th place.

        NANOLEK and the global biotechnology company BeiGene have signed a strategic distribution agreement under which NANOLEK has acquired exclusive rights to the distribution, promotion, pharmacovigilance, and secondary packaging and release control of zanubrutinib, a drug sold under the brand name BRUKINSA®, in Russia and the Eurasian Economic Union (EAEU).

        In late February, NANOLEK summed up the results of 2020: revenue amounted to appr. RUB 12 billion, which is 60% higher than in 2019 (7.5 billion). The investment volume was more than 828 million rubles, which is 66% higher than in 2019 (500 million rubles).

        In 2020, tax deductions to the budget of the Kirov region (a place where the NANOLEK biopharmaceutical plant is located) amounted to 225.9 million rubles, which is almost 2.5 times higher than in 2019 (100 million rubles)

        NANOLEK was granted a market authorization for Rituximab (INN). The authorization was issued on February 11, 2021 by the Ministry of Health of the Russian Federation, for a period of 5 years.

        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.


        2020

        2020

        NANOLEK began 2020 by receiving a prestigious award: the company took the first place in the Large Fast-growing Companies category in the TechUspekh-2019 rating.

        At the end of March, NANOLEK and Efferon announced the beginning of a strategic partnership to actively market a unique medical product, in particular, two types of Efferon sorption columns.

        The device is used for extracorporeal blood purification. It can also be used in the treatment of acute respiratory infections caused by SARS-CoV-2 (COVID-19).

        In mid-April, the company summed up the results for 2019: the revenue amounted to 7.5 billion rubles, which is 60% higher than in 2018 (4.7 billion). The volume of investments amounted to more than 500 million rubles.

        In 2019, tax payments to the budget of the Kirov Region (where the NANOLEK Biopharmaceutical Plant is located) amounted to about 100 million rubles, which is 2.5 times higher than in 2018 (40 million).

        An Auditor’s Report was made by the Independent Auditor of Crow Rusaudit LLC on the annual accounting (financial) statements of Nanolek LLC for 2019, dated 10 April 2020. The Auditor made the opinion that the Accounting (financial) statements of Nanolek LLC are reliable and sufficiently reflect the financial results of operations and cash flows of Nanolek LLC.

        At the end of April, the small investment company Invak, a joint venture of Nanolek LLC and the Federal State Budgetary Institution for Science and Technology of the RAS named after M. P. Chumakov, applied for registration the first domestic inactivated polio vaccine (IPV).

        Nanolek LLC entered the list of systemically important organizations of the Russian economy.

        The decision to include the organization in the list was taken by the government commission to increase the sustainability of the development of the Russian economy.

        The industry list was posted on the website of the Ministry of Industry and Trade of Russia on 25 April 2020.

        NANOLEK joined the American Chamber of Commerce (AmCham Russia).

        President of NANOLEK Vladimir Khristenko: «For NANOLEK, membership in AmCham Russia is an important step in the realities we see today. The world is changing, and we all must support each other, exchanging experience and ideas, and be at the forefront of the international scientific and business plan.»

        NANOLEK and COMBIOTECH announce a long-term strategic partnership to produce an entirely domestic 4-valent vaccine against human papillomavirus (HPV) Type 4 (6, 11, 16, 18), which causes cervical cancer.

        According to the World Health Organization, cervical cancer (CC) is only cancer that can be prevented by primary prevention — vaccination against HPV.

        The full-cycle production of the medicine will begin at the production facilities of NANOLEK in the Kirov Region; investments in the project will amount to about 1.8 billion rubles. The planned time limit for completing preclinical trials is mid-2020, clinical trials will continue until the end of 2022. At the end of 2023, it is scheduled to register and start the production of the medicine.

        In May, NANOLEK and Sanofi announced a new stage in the development of a long-term partnership to localize in Russia the full-cycle production of a five-component combined pediatric vaccine developed by the company Sanofi, in particular, successful bottling of validation series.

        At the biomedical production complex of NANOLEK in Kirov, the stability of three validation series of a five-component combined pediatric vaccine (Pentaxim®) is being studied with the participation of representatives of Sanofi. In accordance with the Technology Transfer Agreement, quality control will be carried out during the established period.

        In the middle of June, NANOLEK was given a market authorization by the Ministry of Health of the Republic of Belarus for the socially significant drug «Hunterase» used in the treatment of the rare orphan disease Mucopolysaccharidosis type II.

        The market authorization is issued for a period of 5 years.

        Market authorizations for this drug were earlier issued in Russia and Kazakhstan as well.

        In the middle of August, Immolab, a subsidiary of Nanolek LLC, obtained the status of the Skolkovo project participant. The company is going to develop a vaccine against COVID-19 by receiving support from the Innovation center. The relevant entry was made in the register on August 12, 2020.

        In September 2020, NANOLEK was included in the first Forbes' ranking "Top Russian pharmaceutical companies". Vladimir Khristenko, President of NANOLEK, and Maxim Stetsyuk, Executive Director of the company, have been ranked among the Top Managers in Russia by the Russian Association of Managers.

        Market authorizations for the drugs "Nebivolol-Nanolek" and "Ramipril" were issued by the Ministry of health of the Republic of Uzbekistan. Market authorizations shall remain valid for a period of 5 years. The Republic of Uzbekistan became the fourth export country in a row in terms of delivery of various drugs.

        In November 2020, NANOLEK has won PRIORITET Awards 2020 in the nomination «Localization of production» for HUNTERASE® — the drug used in the treatment of Hunter syndrome».

        In December, NANOLEK corporate media hit the top 3 list in the «Silver Threads 2020» contest: they took the second place in the category «Best corporate account in social networks» and the third place in the nomination «Best corporate magazine».

        In December 2020, the biopharmaceutical company NANOLEK and Sechenov University, one of the leading research universities in Russia, signed an agreement on strategic and technological partnership in the development of immunobiological drugs.

        Intellectual and technical potential of the joint partnership will cover the entire range of activities aimed at development of immunobiological drugs, including vaccines, from the creation of a drug concept to the production of finished medicines and preclinical trials.

        This cooperation is expected to become the first step on the pathway of successful partnership between fundamental science and state-of-the-art production.

        NANOLEK received a registration certificate from the Ministry of Health of the Republic of Belarus for the POLIMILEX medicine — an inactivated vaccine to prevent poliomyelitis.



        2019

        February 2019

        NANOLEK registers an HIV drug (Atazanavir-Nanolek) in the State Register of Medicinal Products

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        March 2019

        NANOLEK announces the start of clinical trials of a vaccine against pneumococcal infections; the project will facilitate the uninterrupted provision of a highly effective and safe drug, included in the list of the National Vaccination Schedule (NVS), to citizens of the Russian Federation and the CIS

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        April 2019

        NANOLEK becomes a member of the Developing Countries Vaccine Manufacturers Network (DCVMN)

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        June 2019

        NANOLEK and veterinary market leader MSD Animal Health sign an agreement for production of veterinary vaccines in Russia

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        July 2019

        NANOLEK and Chumakov Scientific Center establish joint enterprise Invac to manufacture a domestic inactivated polio vaccine (IPV)

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        August 2019

        NANOLEK withdraws from the list of RUSNANO portfolio companies

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        October 2019

        NANOLEK and Janssen, a pharmaceutical products division of Johnson & Johnson LLC, announced the localization in Russia of the production of Darzalex® (daratumumab) used in the treatment of multiple myeloma

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        November 2019

        NANOLEK and Sanofi are signing a Memorandum of Intent on the start of a new project to localize the production of a combined conjugate vaccine for the prevention of meningococcal infection



        December 2019

        NANOLEK and Merck announce the start of a full production cycle for the manufacture of "Concor" to treat arterial hypertension, coronary heart disease and chronic heart failure.

        10dec

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        NANOLEK and Sanofi announced the successful completion of the first stage of supplies of the Pentaxime® vaccine produced at the NANOLEK biomedical facility under a two-year government contract (for 2019–2020). In total, 3.5 million doses of the vaccine were manufactured and delivered in 2019, which made it possible to protect about 1 million children from five dangerous infections: tetanus, pertussis, diphtheria, polio and Hemophilus type b infection.



        2018

        March 2018

        Green Cross (South Korea) and NANOLEK register a drug in Russia for treatment of Hunter syndrome

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        July 2018

        Signing of a cooperation agreement between NANOLEK, the Government of Kirov Oblast, VyatSU, and Kirov State Medical University (KSMU), for the creation of a Regional Center for Clinical Research, which will enable the launch of full-cycle production of domestic drugs in Kirov Oblast

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        NANOLEK once again confirms conformity of its quality management system to the best international standards and obtains updated ISO 9001:2015, GOST R ISO 9001:2015 and IQ Net certificates pertaining to the transfer, production, packaging, storage and release of sterile and non-sterile drugs, including vaccines, blood products, immunomodulators, monoclonal antibodies, and cytokines



        December 2018

        NANOLEK and the German pharmaceutical company Merck launch full-cycle production of prediabetes and Type-2 diabetes mellitus drugs

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        2017

        March 2017

        Assignment by Russian Ministry of Health of orphan status to the drug Hunterase (Idursulfase)


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        Signing of cooperation agreement with the National Immunobiological Company

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        April 2017

        Launch of a second line of solid dosage forms and a line for small-batch production

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        Launch of cooperation with pharmaceutical company RIEMSER Pharma GmbH (Germany)

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        May 2017

        Approval granted for the second and third phase of clinical trials into an innovative influenza vaccine

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        August 2017

        Extension of IS0 9001 certificate for full-cycle production of biotechnology drugs

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        September 2017

        Signing of an agreement with SK Chemicals (South Korea) for the development and production of vaccines

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        December 2017

        Release of the latest series of the inactivated polio vaccine for the National Vaccination Schedule, to cater for the 2017 supply requirement

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        2016

        March 2016

        Conclusion of an agreement with Aspen to localize the low molecular weight heparin Fraxiparine (nadroparin calcium), a leading drug in the thromboprophylaxis segment in Russia, at the NANOLEK plant

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        April 2016

        Award of a patronage certificate by the Governor of Kirov oblast

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        September 2016

        Signing of strategic partnership agreement with TEVA (Israel)

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        November 2016

        Launch of biotechnological production (including manufacture of inactivated polio vaccine (IPV)

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        December 2016

        Completion of the first phase of clinical trials of an innovative influenza vaccine

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        2015

        March 2015

        Signing of an agreement with biotechnology company Green Cross (Republic of Korea) on strategic partnership for the development and production of high-tech biopharmaceuticals

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        June 2015

        Launch of serial production of solid dosage forms at the NANOLEK plant in Kirov Oblast

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        Signing of an agreement with Sanofi Pasteur to localize the 5-component combination vaccine Pentaxim®



        September 2015

        Signing of an agreement with EGIS and Celltrion (Korea) to localize the rheumatoid arthritis drug Flammegis®, a biosimilar of Infliximab

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        Award of international and Russian ISO 9001 quality certification

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        October 2015

        Signing of an agreement with Merck to localize the production of drugs to treat diabetes and cardiovascular diseases (Glucophage, Concor)



        2014

        December 2014

        Award of a license from the Ministry of Industry and Trade of the Russian Federation for the production of sterile and non-sterile medicinal products; official launch ceremony for the production of solid dosage forms (building 5)

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        2013

        March 2013

        NANOLEK, alongside BIOCOM, wins competitions of the Ministry of Industry and Trade of the Russian Federation on the development and organization of production of chemotherapy drugs Lomustine and Procarbazine, as well as the drug Tretinoin for treating leukemia and Hydroxychloroquine

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        July2013

        NANOLEK, alongside the Epidbiomed Group, wins the competition of the Ministry of Industry and Trade of the Russian Federation for the transfer of foreign developments of the recombinant influenza vaccine based on virus-like particles produced using a lentiviral vector



        2012

        July 2012

        July 26 – start of construction of the NANOLEK production complex in Kirov Oblast; ground-breaking ceremony involving the Governor of Kirov Oblast



        November 2012

        Signing of an agreement with Bilthoven Biologicals (Netherlands) on the development, technology transfer, and organization of production of the first domestic inactivated polio vaccine

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        December 2012

        The Governor of Kirov Oblast awards NANOLEK a patronage certificate as one of the most promising investment projects

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        2011

        April 2011

        The official date of NANOLEK incorporation




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