Nanolek
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Russian biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. It was created RUSNANO in 2011 together with the Epidbiomed group of companies. The total investment in the project amounted to 4 billion, rubles including co-financing of RUSNANO in the amount of 1.28 billion rubles.
Nanolek specializes in the production of import-substituting and innovative drugs, both in-house and created with the involvement of international partners. One of the manufacturers of pediatric vaccines in the Russian Federation. In total, Nanolek has 20 drugs in its portfolio, another 35 are at various stages of preparation for release and will enter the market within the next five years (data for December 2021). In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases (data as of April 2022).
Nanolek supports scientific educational activities in active cooperation with ROOG (Russian Society of Oncohematologists). The Company promotes the development of a further educational program for hematologists for future indications of CLL, Waldenstrom macroglobulinemia and marginal zone cell lymphoma.
Performance indicators
2021: Revenue growth by 57% to RUB 19.5 billion
The Nanolek biopharmaceutical company shared the Zdrav.Expert financial results of 2021 on April 14, 2022. For the second year in a row pharmaceutical , the company showed rapid growth. So, in 2020, revenue increased by 70% to 12.4 billion, and in rubles 2021 the company took a new height: annual revenue reached 19.5 billion rubles, which is 57% higher than a year earlier. Over the year, more than 30 million packages of drugs were produced.
Despite the fact that the name of the company in 2021 often sounded in connection with the vaccine "KoviVak," which in December began to be produced at the Nanolek plant in the Kirov region by order of the developer - the Center named after Chumakov, the main growth driver was not "covid." As noted in the company, Covidolek contributed, showing a significant increase in sales, but in general, drugs related to the treatment of covid brought less than 20% of revenue.
According to Nanolek estimates, the key part of the annual turnover in 2021 fell on the production of drugs from the main portfolio. For liquid dosage forms - due to pediatric vaccines, Polymilex and Pentaxim. For solid dosage forms (tablets), a significant share of growth was ensured by the production of a record amount of Concor, which is used for coronary heart disease and heart failure.
In 2021, Nanolek signed an agreement with Sanofi on the production of meningococcal vaccine Menactra, which is an important milestone in the formation of the company's pediatric portfolio. Already at the end of February 2022, the partners released the first series of Menaktra at a plant in the Kirov region.
In 2021, thanks to Nanolek Russian , two new drugs appeared on the market: small-molecule heparin for the prevention of thromboembolism - "Cibor" and a drug for the treatment of mantle-cell lymphoma - "Brookins." "Efferon" The company considers original specialized drugs such as Brookinza, Hunteraza, Cibor, as well as sorption columns to be growth points.
The company allocated a total of 1.5 billion rubles for development in 2021 (70% more than last year). Of these, about 0.7 billion rubles were allocated for the development of the company's portfolio, including clinical trials of the domestic vaccine against HPV (papillomavirus) - the joint development of Nanolek and Kombiotech. The company also continued the annual modernization of the plant in the Kirov region, including the opening of a biochemical laboratory with an area of more than 140 m2 in December.
According to Mikhail Nekrasov, CEO of Nanolek, the company has been increasing its competencies for 10 years and has learned a lot through partner projects with global players of "big pharma." At the beginning of 2021, Nanolek adopted an updated strategy for the next five years, and the increase in annual turnover by 57% is the result of a clear direction that the company set itself a year ago.
 | "The difficult situation in the Russian economy associated with sanctions is likely to affect our company. We await the decision of our international partners on previously planned investment projects, which they are revising. But basically our plans remain in force, even despite the growth of the key rate to 17%, "said the head of the company. |  |
The company is moving in accordance with the strategy adopted a year ago: it is strengthening the import substitution line and continues to invest in full-cycle biotechnological production at a plant in the Kirov region, including the development of substances for vaccines. In total, it is planned to allocate up to 5 billion rubles for these purposes over the next three years, added Mikhail Nekrasov.
History
2024: Intero Invest and DD Kalita acquired shares in Nanolek
On April 17, 2024, it became known that the management companies Intero Invest Sergey Ostashevich and DD Kalit Vasily Kulkov acquired 25 percent shares in the Russian pharmaceutical company Nanolek, which specializes in the production of import-substituting drugs (including vaccines) for the prevention and therapy of socially significant diseases. The amount of the transaction is estimated at 9-10 billion rubles.
Pharmaceutical company "Nanolek" was founded in 2011 by the son of former Deputy Prime Minister Viktor Khristenko Vladimir. Since 2012, it has been owned by the Cypriot Nanolek Holding Limited. Since 2019, the ultimate beneficiaries of the company have been Nanolek President Vladimir Khristenko, former deputy of the Legislative Assembly of the Kirov Region and CEO of the company Mikhail Nekrasov, as well as their partners Yevgeny Weinstein and Andrei Reus. In May 2023, Nanolek moved to K2 Group when the company was re-registered from Cyprus to Russia. At the same time, the K2 Group received indirect control over the Nanolek enterprise a little earlier - in the summer of 2022, having bought out the parent structure of the company.
According to the Vedomosti newspaper, referring to data received from the general director of Infoline analytics Mikhail Burmistrov, Kulkov and Ostashevich paid 4.25-4.75 billion rubles for 25 percent shares in the pharmaceutical company. The remaining 50% of the enterprise retained the K2 Group, which belongs to the former chairman of the board of directors of Nanolek Anton Pak.
It is noted that Vasily Kulkov is the son of Yegor Kulkov, who, together with Viktor Kharitonin, Roman Abramovich and other shareholders of Sibneft, founded the Pharmstandard company in 2003. DD Kalita has been owned by Vasily Kulkov since February 2021.[1]
2023
Plan to invest 5 billion rubles in the production of vaccines against HPV, chickenpox and others in the Kirov region
On October 31, 2023, the Governor of the Kirov Region Alexander Sokolov and the General Director of Nanolek Vladimir Nesterenko signed a number of agreements on cooperation in the socio-economic sphere. Among the signed documents are an agreement of intent to implement an investment project for the production of biotechnological substances and vaccines on the territory of the Nanolek biomedical complex for 5 billion rubles and a roadmap for the further development of the social infrastructure of the Orichevsky district of the Kirov region.
Cooperation between the Kirov region and Nanolek is aimed at strengthening the investment climate and developing particularly significant areas for the region: the biotechnology industry, the special economic zone, transport infrastructure, social formations protection and employment. population
Nanolek plans to implement an investment project to create new capacities for the production of biotechnological substances and vaccines for the prevention of socially significant diseases. Among the drugs planned for production at the planned facilities within the framework of the investment project are Nanolek's own vaccine against the human papillomavirus, a vaccine against chickenpox, meningococcal infection and other vaccines for the prevention of socially significant diseases.
The company plans to implement an investment project in 7 years, from 2025 to 2032. Nanolek will produce an additional 14 million packages of drugs per year and will create 280 new jobs.
The volume of tax payments for ten years of drug production is about 4 billion rubles.
In the period 2011-2023 the volume of Nanolek investments in the biomedical complex in the Kirov region amounted to more than 12 billion rubles, the amount of tax payments - 2 billion rubles.
Within the framework of the road map signed by the parties for the joint development of social infrastructure in the village of Lyovintsy, Orichevsky district, Kirov region, where the Nanolek plant is located, joint work is envisaged in the field of support for kindergarten and school under the state program of the Kirov region "Development of education"; Nanolek's participation in events to create a comfortable urban environment in the Orichevsky district; development of the transport sphere by extending bus routes and creating an additional bus stop.
Nanolek has been providing versatile support to the Orichevsky district since 2011, when the construction of the company's plant began.
| | In any collaboration - public or private - it's like a win-win system - everyone should be the winners. First of all, people who work at the enterprise live in Kirov, Orichevsky district or Lyovintsy. We signed a double agreement just about this - about people. So that we jointly create a social base and infrastructure for people: education, culture, housing. We see that the enterprise is developing very efficiently, the volume of production is increasing, they occupy their unique niche. For all regions, the main problem now is the availability of opportunities to attract labor resources. Colleagues from Nanolek understand this, trying to solve this problem by action. Together with us, they are developing a common project to create infrastructure for people here, they are attracted by more favorable economic conditions, - commented Alexander Sokolov, Governor of the Kirov Region. | |
| | The partnership between Nanolek and the Kirov region began at the time of confirmation of plans for the construction of the plant in 2010 and continues constructively to this day. By contributing to the development of the region, we provide synergy and mutual development in completely different areas. Let me give you an example. Despite the change in the situation in the supply of foreign components for production, Nanolek found partners in the small business segment of the Kirov region. For 9 months of 2023, due to work with local manufacturers in the field of mechanical engineering and the production of spare parts, the company saved about 50 million rubles. I note that parts from Kirov manufacturers are approved by global quality services for use in the production of drugs by Nanolek partners - international pharmaceutical companies - at our plant in the Kirov region. This indicates a high level of local engineering, - noted Vladimir Nesterenko, General Director of Nanolek. Speaking of personnel potential, I would like to note that the company not only creates a comfortable environment in the surrounding areas, but also actively cooperates with Vyatka State University, a supporting university in the region with great scientific and educational potential. Such multilateral cooperation in various fields allows Nanolek to solve issues of development and release of new drugs, personnel tasks, in turn contributing to the development of biotechnological specialization of the Kirov region. | |
Registration of the company in the Russian Federation
In early June 2023, it became known about the change of registration of Nanolek from Cypriot to Russian. Legally, the new owner of the vaccine manufacturer was the K2 Group company registered in the Russian Federation.
As Vedomosti writes with reference to the data of the SPARK-Interfax system, the deal was closed on May 24, 2023. Before that, it was owned by the Cypriot Nanolek Holding Limited, and since April 28, the Management-Asset investment fund (it is also managed by the K2 Group Management Company).
| | The changes that have occurred are associated with new regulatory requirements for Russian business, "a Nanolek representative told the newspaper. | |
According to him, the old ownership structure in the current conditions has ceased to be relevant. He did not disclose other details.
The press service of Nanolek confirmed the information about the re-registration of the company. They explained that earlier registration in Cyprus was necessary to facilitate work with international partners.
K2 Group is owned by Anton Pak, former chairman of the Nanolek board of directors. By the beginning of June 2023, this position (like the council itself) was abolished, Pak does not hold other posts in the company, specified in Nanolek. Pak worked in the banking sector, including deputy chairman of the IFC bank, and also headed the North Caucasus Development Corporation.
According to Natalia Abtseshko, head of the international projects group at Vegas Lex law firm, Russian business, in whose capital foreign shareholders participate, is experiencing a number of difficulties by June 2023. For example, difficulties arise when the parent and subsidiary companies interact in the supply of goods and the provision of services. DSM Group CEO Sergei Shulyak also notes that recently cases of sale of companies to management have become more frequent. This is common practice to take businesses out of the risk of sanctions.[2]
Appointment of Vladimir Nesterenko as General Director of Nanolek
Vladimir Nesterenko became the general director of Nanolek. Its co-founder and former leader Mikhail Nekrasov decided to leave his post and focus on scientific activities. This was reported to Zdrav.Expert by representatives of Nanolek on May 17, 2023. Read more here.
2022
The departure of Vladimir Khristenko from the post of president of Nanolek
Nanolek co-founder Vladimir Khristenko announced his resignation from the presidency, which he has held since 2015. This was announced on December 29, 2022 by Zdrav.Expert representatives of the Nanolek company. He transferred the full leadership of the pharmaceutical company - the supplier of 25% of vaccines for the national vaccination calendar of Russia - to his partner, General Director of Nanolek Mikhail Nekrasov. The composition of the company's shareholders remains unchanged. Read more here.
Visit of Dmitry Chernyshenko
On August 26, 2022, as part of a working visit to the Kirov Region, Deputy Prime Minister of the RFD Chernyshenko visited the Nanolek plant.
Dmitry Chernyshenko highly appreciated the activities of the enterprise, stressing that there is a huge potential for further development and import substitution in the field of pharmaceuticals.
The company continues its first major project in the field of import substitution - the domestic HPV vaccine, the development of Nanolek and Kombiotech: the 3rd phase of a clinical study is underway in August 2022). The vaccine should hit the market in 2025. The company will equip a separate building at the plant for this project and will produce it according to the full cycle - this is another breakthrough for Nanolek.
Шаблон:Quote 'author = said Dmitry Chernyshenko, Deputy Prime Minister of the Russian Federation.
{{quote 'author = noted Mikhail Nekrasov, General Director of Nanolek. |
In light of the course of the Russian Federation for intensive import substitution, the ideal moment has come to actively start with the launch of the Biopolis project. Our company will become its anchor resident and we will only be pleased to welcome the emergence of other strong players alongside us in the future of Biopolis. We are not afraid of competition: according to world studies, the more strong players connect in one cluster, the better they all develop. Behind them will pull up infrastructure, and new "smart" jobs, and science, and education,}}
2.2% increase in staff, to 842 people
The Russian biopharmaceutical Nanolek on April 27, 2022 reported an increase in staff and additional vacancies in light of the course at. Since the import substitution end of February, the company's staff has grown by 2.2%, to 842 people, and the number of open vacancies has increased due to the exchange rate for import substitution.
| | Nanolek did not stop the process of searching for candidates for vacant positions for a minute, moreover, we strengthened the focus of searching for candidates for positions of researchers in our R&D-a center in the city, Pushchino as well as technologists/biotechnologists at the plant in. Under Kirov state the import substitution agenda, this has become more relevant than ever, "said Maria Voronina, Deputy General Director of Nanolek for Personnel Management and Administrative Affairs. | |
According to her, the attractiveness of regional vacancies in Kirov for candidates will grow in the future: Nanolek is an anchor resident of a special economic zone in the Kirov region with a focus on biotechnology and pharmaceuticals - Biopolis. For April 2022, Biopolis is in the active design stage, and in a few years, when it is implemented, the company expects a qualitative influx of young scientists and pharmacists. A comfortable environment for life and self-realization, as well as communities in the "city of scientists" will become another argument for relocation.
In the active phase and cooperation with universities: "Nanolek" makes it possible to undergo production practice and internship to future specialists from Vyatka State and,, St. Petersburg State Chemical and Pharmaceutical University RNIMU named after N.I. Pirogova Ministry of Health of Russia RUDN research institutes HSE and other universities. Successful graduates get a chance to become young specialists at Nanolek.
As of April 2022, more than 10 vacancies have been opened in the company:
- preclinical and clinical research manager,
- researcher (biochemistry/isolation and purification),
- researcher (genetic engineering),
- Research Fellow in Cellular Technology,
- Process Engineer/Biotechnologist,
- Drug Registration Manager,
- Key Account Manager (Commerce, Vaccines),
- Health Care Structure Manager,
- analyst in the Department of Strategic Development,
- regional health information specialist.
Investing 3.5 billion rubles in the launch of vaccine production in a full cycle
The design of the building for the production of vaccines in a full cycle, including the development of substances, at the Nanolek plant in the Kirov region will be completed by the summer of 2022, and in 3 years they plan to start producing the first fully domestic vaccine against the human papillomavirus (HPV). This was announced on March 23, 2022 by Zdrav.Expert representatives of Nanolek. The project in the company was called "Our Tesla."
Photo: kirov.online
As part of the project, the Nanolek biopharmaceutical company is reconstructing a production building with a total area of more than 2.5 thousand m2 at an innovative plant Kirov in the region. In addition to the zones for the production of the active pharmaceutical substance, production control laboratories, engineering systems, offices and auxiliary premises will be located here.
The layout and concept of the case will meet the global Good Manufacturing Practice standards, which establish requirements for production and quality control at high-tech pharmaceutical enterprises. The production will be equipped with biotechnological equipment from Russian and international suppliers. The design of the hull is scheduled to be completed in the second quarter of 2022.
According to Nanolek, the total investment in the Nasha Tesla project will amount to more than 3.5 billion rubles. Of these:
- 1.5 billion rubles will be allocated for the main technological equipment,
- for engineering systems - 1 billion rubles,
- for laboratory equipment - more than 150 million rubles,
- for the transfer and scaling of production technology - 850 million rubles.
As specified, the company has already invested several hundred million rubles in the Nasha Tesla project and plans to apply for a loan to the Industry Development Fund under the Priority Projects program. The cost of equipment due to the current difficulties of working with European suppliers, as well as the search for new potential partners in other markets, will increase, according to Nanolek, by 20-30%.
The first product within the framework of the Our Tesla project will be a completely domestic vaccine against the human papillomavirus - this is a joint development of Nanolek and Kombiotech (the developer and manufacturer of the full cycle of the recombinant hepatitis B vaccine). The capacity of the production building will allow the production of up to 8 million doses of the finished HPV vaccine from 2025, the company noted.
Prevention virus will help reduce mortality from. cancer Human papillomavirus (HPV) causes cancer and precancerous conditions of the cervix, vagina, external female genitalia, penis and anus, and some head and neck cancers in adults. According to data published in 2021 in the scientific journal Lancet, HPV vaccination reduces the risk by 90% - cervical cancer a disease from which more than 300 thousand people die annually. This is a vaccination without age, but above WHO all recommends that girls from 9 to 13 years old, and among people 27-45 years old - first of all, people living with HIV, and. smoker The vaccine is already included in the national calendars of preventive vaccinations in 91, in Russia country of the world as of March 2022 it is included in separate regional vaccination calendars, it is planned to add it to the national calendar in 2024. So far Russia , only foreign vaccines are available to residents.
| | "We started developing the Our Tesla project almost two years ago, in the midst of a pandemic. Our own production of vaccines, which are included in the National Calendar of Preventive Vaccinations, is a priority for us. The "Our Tesla" project will help bring to the market one of the most important vaccines that will significantly reduce the oncological incidence in women, "said Vladimir Khristenko, President of Nanolek. | |
In 2021, preclinical studies of the vaccine were completed, according to the results of which the domestic drug showed a more favorable safety profile and better tolerability than the drug produced in the United States. The risk of adverse events was 7% lower than that of the reference drug, while all changes in the well-being of the subjects were mild - mainly reactions at the site of vaccine administration, for example, redness, itching and tenderness when pressed. The Russian vaccine also showed good immunogenicity: most volunteers developed antibodies to all four of the most common oncogenic strains after a single administration.
2021
Production in the Kirov region
The company's plant in the Kirov region, opened in 2014, was built with an eye to the best world practices and technologies. The production not only has a GMP certificate, but also regularly undergoes quality audits of large international pharmaceutical corporations: according to information for December 2021, the Nanolek plant produces drugs together with companies such as Sanofi, Janssen, Merck, Aspen.
Attracting 2 billion rubles for the production of vaccines against the human papillomavirus and a drug for the treatment of lymphoma
On October 21, 2021, it became known that the expert council of the Industrial Development Fund (FRP) approved the Nanolek company a loan in the amount of 2 billion rubles for the localization of pharmaceutical production.
As the press service of the FRP clarifies, the funds presented within the framework of the Priority Projects program will be used to manufacture active pharmaceutical substances of the vaccine against human papillomavirus and a monoclonal antibody for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and some other diseases. If necessary, the production capacity will cover the annual needs of the Russian market for these drugs, added to the FRP.
The total cost of the project is estimated at 4 billion rubles. The source of receipt of the remaining 2 billion rubles by October 21, 2021 is not called. It is only known that Nanolek will allocate part of the money from its budget.
Within the framework of the project, it is planned to reconstruct one of the buildings of the Nanolek biomedical complex in the Kirov region. The company will direct the loan funds to the purchase of production equipment. Own funds will be used to purchase technologies, transfer them, conduct the entire complex of preclinical and clinical studies, as well as registration procedures.
The implementation of the project will allow the release of the first fully local vaccine against the human papillomavirus in Russia, as well as reduce the cost of production and more quickly approach the development of new drugs and vaccines in the event of epidemiological threats, indicate in the FRP.
In the period from 2024 to 2028, the company plans to release up to 250 thousand packages of monoclonal antibody for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and up to 11.3 million packages of vaccine against human papillomavirus.[3]
Opening of the R&D center for 50 million rubles
In September 2021, Nanolek opened R&D a center in the science city of Pushchino. Investments in this project amounted to 50 million, and rubles within five years the pharmaceutical company plans to invest about 2 billion rubles in the development of drugs.
The R&D Center "Nanolek" began working on the basis of the Pushchinsky Institute of Biological Instrumentation of the Russian Academy of Sciences, whose scientists are engaged in new technologies in physicochemical biology , medicine and pharmacology. Andrei Ulitin, laureate of the state prize in the field of science, became its scientific director, the team included candidates of biological sciences and senior researchers - experts in cell technology, cell biology and genetic engineering. The management of the R&D center and its integration into the Nanolek strategy will be provided by Svetlana Zakirova, Candidate of Biological Sciences, Deputy General Director for Research and Development.
The laboratory in Pushchin will focus on vaccines and monoclonal antibodies for the treatment of cancer.
By September 2021, five drugs were presented in the portfolio of the Nanolek R&D Center:
- polyvalent vaccine against coronavirus and influenza;
- Herpes Zoster vaccine - it is given to people aged 50 and over;
- two biosimilar monoclonal antibodies;
- one original monoclonal antibody.
| | In pharmaceuticals, investing in early development is extremely risky. We decided to create our own R&D center and develop our own drugs from scratch, only having accumulated serious competencies in the production and transfer of technologies, "said Vladimir Khristenko, President of Nanolek. | |
According to him, Nanolek plans to become a leader among vaccine manufacturers in Russia within five years, adding at least four new vaccines to its portfolio.[4]
2020: Revenue growth by 70% to RUB 12.4 billion
In 2020, Nanolek's revenue amounted to 12.4 billion rubles, which is 70% more than in 2019.
2019: Implementation of the Marking project in Nanolek
- Potential use of MDLP data
- Main Article: FGIS MDLP Monitoring Drug Movement
Summary
- Labeling of medicinal products is a global and, apparently, inevitable process that takes place in the world markets Russia, USA, EU, Turkey, etc.)
- So far, there is no unambiguous understanding of the benefits of the labeling process, but participants in the commodity distribution chain have the opportunity to influence the system and achieve a mutually beneficial partnership with the regulator in terms of using data on the movement of goods
- The MDLP system has great potential to increase the transparency of trade and logistics processes for labeled goods
- Despite the local success of the implementation of the Marking project, a pilot operation stage is required for all participants in the distribution chain
2015
Revenue - 300 million rubles
The company's revenue in 2015 amounted to 300 million rubles.
Project to create a biotechnological complex in the Orichevsky district
As of August 2015, a project to create a modern biotechnological complex was being implemented in the Orichevsky district of the Kirov region (in 2014, the first stage of production was launched).
Portfolio company Rusnano Nanolek opens a laboratory of pharmaceutical technologies at Vyatka State University
On August 7, 2015, the Vyatka State University hosted the grand opening of the pharmaceutical biotechnology laboratory to train future employees of the biomedical complex of NANOLEK LLC (the village of Lyovintsy, Kirov Region).
The laboratory equipment is intended for mastering all stages of the development and production of modern biologics: from the cultivation of producer strains in a laboratory bioreactor to the isolation and purification of the target protein by ultrasonic disintegration, centrifugation, electrophoresis and chromatography and the production of finished dosage forms of preparations using a laboratory tablet press and a granulator. The equipment of the laboratory allows you to control the quality of drugs at all stages of their production - microscopes, spectrophotometers, tablet analyzer, etc. are used for this.
The total investment of NANOLEK LLC in the training of production personnel at Vyatka State University today has already amounted to more than 8 million rubles. So, in August 2015, the university launched a professional retraining program "Development of immunobiological drugs and technologies for their production," prepared by order of the Fund for Infrastructure and Educational Programs of RUSNANO and NANOLEK. Students of the program were both current specialists of the enterprise and graduates of the university in 2015 with a degree in biotechnology. Along with full-time training, the program uses specially designed electronic training modules - this allows you to effectively train specialists already working at the enterprise. Participants in the educational program can specialize in such areas as the production of vaccines, the manufacture of drugs based on monoclonal antibodies and recombinant proteins, management in biopharmaceuticals and the production of finished dosage forms.
VyatSU's cooperation with NANOLEK began even before the official launch of production: the university created an infrastructure in the field of biotechnology, which includes training laboratories of two departments, two scientific and educational centers - Nanotechnology and Bioengineering and several specialized laboratories, including the Laboratory of Physiology of Microorganisms, functioning at the university as a joint laboratory with the Komi Institute of Physiology of the Russian Academy of Sciences. In 2014, a recruitment for a new preparation profile was opened - "pharmaceutical biotechnology" with a high competition (on average, 6 people per place).
Notes
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