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

This is the first pharmaceutical approval of Baiyueze® in Russia

At present, Baiyueze® has been approved for the treatment of mantle cell lymphoma in 10 countries, including the United States, China, Canada, Australia and other countries

BeiGene is committed to rapidly advancing the global registration of BeiGene through independent declaration or cooperation with strategic partners

Based on an exclusive distribution agreement, Nanolek will be responsible for the commercialization of Baiyueze® in Russia

Beijing time October 20, 2021, BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) is a global biotechnology company focusing on the development and commercialization of innovative drugs worldwide , To improve the treatment effect and the accessibility of medicines for patients around the world
.
Nanolek is a Russian biopharmaceutical company specializing in the production of imported alternative drugs and innovative drugs

"Baiyueze® is a new generation of BTK inhibitors, which can improve the clinical benefits of patients and reduce off-target side effects
.
The approval of Beyueze® will bring new choices for clinicians and patients and is expected to help Russian MCL patients receive treatments with better prognosis and better tolerability

Dr.
Huang Weijuan, Chief Medical Officer of BeiGene Hematology, said: “This approval once again confirms the potential of Baiyueze® as a potential'best-in-class' BTK inhibitor for the treatment of hematological malignancies
.
We are very much I am happy to bring this drug to patients with MCL in Russia

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 most common adverse event was infectious pneumonia (11%).
And bleeding (5%)
.
Eight patients (7%) discontinued treatment due to adverse reactions during the trial.

The recommended dose of Baiyueze® is 160mg twice a day or 320mg once a day, which can be taken orally on an empty stomach or after meals
.
The dosage of the drug can be adjusted according to the adverse reaction, and the dosage can be reduced for patients with severe liver damage and who are taking potential drug interactions with Baiyueze®

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”) [i].
MCL patients account for approximately 5% of all NHL cases [i]
.
The incidence of MCL in men is higher than in women[i], and many patients with MCL are diagnosed around the age of 60[i]
.
MCL patients have a poor prognosis, with a median survival of 3 to 4 years, and they are often diagnosed in the late stages of the disease[ii]
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In Russia, there are more than 1,000 new cases of MCL every year[iii]
.

About Baiyueze® (Zebutinib)

Baiyueze® (Zebutinib) is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) independently developed by BeiGene scientists.
It is currently undergoing extensive clinical trials worldwide as a single drug Combined with other therapies to treat a variety of B-cell malignancies
.
Since the new BTK will be continuously synthesized in the human body, Baiyueze® is designed to achieve complete and continuous inhibition of BTK protein by optimizing the bioavailability, half-life and selectivity
.
With its differentiated pharmacokinetics from other approved BTK inhibitors, Baiyueze® can inhibit the proliferation of malignant B cells in multiple disease-related tissues
.

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 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 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 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one treatment in the past**

In February 2021, Baiyueze® was approved in the United Arab Emirates for the treatment of patients with relapsed or refractory MCL

In March 2021, Baiyueze® was approved in Canada for the treatment of adult WM patients

In April 2021, Baiyueze® was registered in Israel and included in the local medical insurance reimbursement list for the treatment of adult MCL patients who have received at least one treatment in the past*

In June 2021, Baiyueze® was approved in China for the treatment of adult WM patients who have received at least one treatment in the past**

In July 2021, Baiyueze® was approved in Canada for the treatment of adult MCL patients who had received at least one treatment in the past**

In July 2021, Baiyueze® was approved in Chile for the treatment of adult MCL patients who have received at least one treatment in the past

In August 2021, Baiyueze® was approved in Brazil for the treatment of adult MCL patients who have received at least one treatment in the past

In August 2021, Baiyueze® was approved in the United States for the treatment of adult WM patients

In September 2021, Baiyueze® was approved in the United States for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20 treatment

In October 2021, Baiyueze® was approved in Singapore for the treatment of adult MCL patients who have received at least one treatment in the past

In October 2021, Baiyueze® was approved in Australia for the treatment of WM adult patients who have received at least one therapy in the past, or as a first-line therapy for patients who are not suitable for chemoimmunotherapy

In October 2021, Baiyueze® was approved in Russia for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past
.

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)
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Full approval for this indication will depend on the verification and description of clinical benefits in confirmatory trials
.

**This indication was approved with conditions
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Full approval for this indication will depend on the results of ongoing confirmatory randomized, controlled clinical trials
.

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
.
The company's global clinical research and development team has about 2,300 people, and the team is still expanding
.
This team is currently supporting more than 90 clinical studies worldwide and has recruited more than 13,000 patients and healthy subjects
.
BeiGene's own clinical development team plans and leads the development and expansion of the company's product pipeline, providing support and guidance for clinical trials covering more than 40 countries/regions around the world
.
At present, three drugs independently researched and developed by BeiGene have been approved for marketing: Baiyueze® (BTK inhibitor, which has been approved for marketing in the United States, China, Canada, Australia and other international markets), Baizian® (effectively Anti-PD-1 antibodies that avoid Fc-γ receptor binding have been approved for marketing in China) and Baihuize® (approved for marketing in China)
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BeiGene has a team that pursues high quality and innovation, based on science and medicine, and has established a leading position in China, building a large-scale commercial team focused on oncology
.

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
.
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
.
For more information, please visit
.

About Nanolek

Nanolek is a Russian biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov
.
The company is committed to the production of imported generic drugs and innovative drugs through independent research and development or co-production with partners
.
Nanolek is one of the leading companies in the production of vaccines for children in Russia
.
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
.
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
.
Company website: Forward-looking statement

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including the development and commercialization plans of Bejoyze® in Russia and other markets, and the potential business of Bejoyze® Opportunity, the launch plan of BaiGene in Russia, BaiGene becomes the best-in-class BTK inhibitor and provides patients with the potential for better clinical benefit.
BeiGene’s plans, commitments, ambitions and goals mentioned under the subheading "Shenzhou"
.
Due to various important factors, actual results may differ materially from forward-looking statements
.
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
.
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
.

references:

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

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

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