BeiGene and Nanolek announced that Baiyueze(R) (Zebutinib) was approved in Russia for the treatment of patients with relapsed or refractory mantle cell lymphoma

Beijing, China, Cambridge, Massachusetts, and Moscow, October 20, 2021/PRNewswire/ - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) is a scientifically based global bio A technology company that focuses on the development and commercialization of innovative drugs worldwide to improve treatment effects and access to drugs for patients around the world

"Baiyueze® is a new generation of BTK inhibitors, which can improve the clinical benefits of patients and reduce off-target side effects

Dr.

Vitaly Sokolinsky, Senior Director of BeiGene’s New Market Development Team in Russia, said: “We look forward to working with Nanolek to bring this clinically urgently needed new therapy to MCL patients

Vladimir Khristenko, President of Nanolek, said: “This approval is an important milestone for the well-being of patients, and we are proud of this

The marketing authorization of Baiyueze® for the treatment of MCL in Russia is based on the results of two single-arm clinical trials

Among the 118 patients with MCL who had received at least one treatment in the past, 36 patients (31%) had serious adverse reactions after receiving Baiyueze® treatment.

The recommended dose of Baiyueze® is 160 mg twice daily or 320 mg once daily, either on an empty stomach or after meals

About Mantle Cell Lymphoma (MCL)

MCL is a rare type of non-Hodgkin's lymphoma (NHL) that occurs on the outer edge of the lymph node (ie, the "mantle area") [1].

About Baiyueze® (Zebutinib)

Baiyueze® (Zebutinib) is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) independently developed by BeiGene scientists.

Baiyueze® has been approved for the following indications in the following regions:

In November 2019, Baiyueze® was approved in the United States for the treatment of mantle cell lymphoma (MCL) patients* who had previously received at least one therapy; in June 2020, Baiyueze® was approved for treatment in China Adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past**; In June 2020, Baiyueze® was approved in China for the treatment of adult chronic lymphocytic leukemia who has received at least one treatment in the past ( CLL) or small lymphocytic lymphoma (SLL) patients**; In February 2021, Baiyueze® was approved in the United Arab Emirates for the treatment of patients with relapsed or refractory MCL; March 2021, Baiyueze® Approved in Canada for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM); In June 2021, Baiyueze® was approved in China for the treatment of Wahrenheit's macroglobulinemia who had received at least one treatment in the past ( WM) patients**; In July 2021, Baiyueze® was approved in Canada for the treatment of adult mantle cell lymphoma (MCL) patients who had received at least one treatment in the past; In July 2021, Baiyueze® was approved in Canada.

So far, Baiyueze® has submitted more than 30 listing applications for multiple indications, covering the United States, China, the European Union and more than 20 other countries or regions

*This indication is based on the accelerated approval of the overall response rate (ORR)

**This indication was approved with conditions

About BeiGene Oncology

BeiGene continues to promote the research and development of best-in-class or first-in-class clinical drug candidates through independent research and development or with like-minded partners, and is committed to providing influential, accessible and affordable drugs to patients around the world

At the same time, BeiGene is also cooperating with other innovative companies to jointly promote the research and development of innovative therapies to meet global health needs
.
In China, BeiGene is selling a variety of oncology drugs authorized by Amgen and Bristol-Myers Squibb
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The company has also cooperated with many companies including Amgen, Biotech, EUSA Pharma, Mirati Therapeutics, Seagen and Zymeworks to meet the current global unmet medical needs to a greater extent
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BeiGene has also reached a cooperation with Novartis, authorizing Novartis to develop, produce and commercialize Bezeran® in North America, Europe and Japan
.

About BeiGene

BeiGene is a science-based global biotechnology company that focuses on the development of innovative and affordable drugs to improve treatment outcomes and access to drugs for patients around the world
.
The company's broad drug portfolio currently includes more than 40 clinical drug candidates
.
The company accelerates the development of diversified and innovative drug pipelines by strengthening independent research and development capabilities and cooperation
.
We are committed to comprehensively improving access to medicines for more than 2 billion people around the world by 2030
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BeiGene has built a team of more than 7,000 people on five continents around the world
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For more information, please visit the official website .

About Nanolek

Nanolek is a Russian biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov
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The company is committed to the production of imported generic drugs and innovative drugs through independent research and development or co-production with partners
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Nanolek is one of the leading companies in the production of vaccines for children in Russia
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Currently, Nanolek has 20 drugs in its product portfolio.
In addition, there are 35 drugs at different stages in the marketing process and are scheduled to be launched in the next 5 years
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The company’s factory was opened in Kirov in 2014.
The factory introduced international standard operations and technology.
In addition to GMP certification, the production facilities also regularly pass the quality inspections of large international pharmaceutical companies.
Cooperate with companies such as Aspen to produce drugs
.
 

Nanolek also actively cooperates with RSOH (Russian Society of Oncology and Hematologists) to promote science education
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Nanolek also provides continuing education programs for hematology doctors for the indications that CLL, Waldenstrom's macroglobulinemia and marginal zone cell lymphoma intend to apply for
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Company website:  

Forward-looking statement

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including the development and commercialization of Baiyueze® in Russia and other markets The potential business opportunities of Baiyueze®, the potential business opportunities of Baiyueze® in Russia, the potential of Baiyueze® to become the best-in-class BTK inhibitor and provide patients with better clinical benefits, and the potential for The plans, commitments, ambitions and goals of BeiGene mentioned under the sub-headings "Jeshen Oncology" and "About BeiGene"
.
Due to various important factors, actual results may differ materially from forward-looking statements
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These factors include the risks of: BeiGene’s ability to prove the efficacy and safety of its drug candidates; the clinical results of the drug candidates may not support further development or marketing approval; the actions of the drug administration department may affect the initiation of clinical trials , Timetable and progress, and drug marketing approval; BeiGene’s ability to market drugs and drug candidates (if approved) to achieve commercial success; BeiGene’s ability to obtain and maintain intellectual property protection for its drugs and technologies; Jeshenzhou’s reliance on third parties for drug development, production and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercialization of pharmaceutical products, and its ability to obtain further working capital to complete the development of drug candidates and realize and maintain profitability ; The impact of the global pandemic of COVID-19 on BeiGene’s clinical development, supervision, commercial operations, and other businesses; and BeiGene’s more comprehensive discussion in the "Risk Factors" section of Form 10-Q in the most recent quarterly report Various risks; and discussions on potential risks, uncertainties and other important factors in BeiGene’s subsequent submission to the U.
S.
Securities and Exchange Commission
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All information in this press release is only as of the date of the press release, and BeiGene has no responsibility to update such information unless required by law
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references:

[1] Lymphoma Research Foundation.
Understanding Mantle Cell Lymphoma.
Available at https://lymphoma.
org/wp-content/uploads/2018/10/MantleCellLymphomaFact-Sheet.
pdf Accessed October 2021.

[2] Philip J.
Bierman, James O.
Armitage, in Goldman's Cecil Medicine (Twenty Fourth Edition), 2012.

[3] https://glavonco.
ru/cancer_register/%D0%9F%D0%BE%D0%BC%D0%BE%D1%89%D1%8C%202019.
pdf.
Accessed October 2021

Source: BeiGene