BeiGene announced that Baiyueze(R) (Zebutinib) was approved for the treatment of mantle cell lymphoma

This is the second indication approved by Baiyueze® in Australia after it was approved for the treatment of Fahrenheit's macroglobulinemia for the first time in Australia recently.

At present, Baiyueze has been approved for the treatment of mantle cell lymphoma in 9 countries 

Beijing, China, Sydney, Australia and Cambridge, Massachusetts, October 11, 2021/PRNewswire/ - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) is a global company based on science A biotechnology company that focuses on the development and commercialization of innovative drugs worldwide

After being approved by the Australian Drug Administration (TGA) for the two indications of Beyze ®, Australian patients can immediately obtain Beyyze ® through the "Post-marketing Approval/Pre-Insurance Drug Use Plan" sponsored by BeiGene

Professor Stephen Opat, Director of Clinical Hematology at Monash University and the principal investigator of the Zebutinib clinical project, said: “Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin’s lymphoma (NHL) and is usually considered to be An incurable disease

“Australia is one of the countries with the highest incidence of NHL in the world.

BeiGene has submitted a reimbursement application for Baiyueze® to the Pharmaceutical Benefits Advisory Committee of Australia (PBAC), of which MCL indications have been recommended to be included in the reimbursement subsidy list in July 2021

Dr.

In Australia, more than 6000 people are diagnosed with non-Hodgkin's lymphoma (NHL) each year, which is also the sixth most common cancer among Australian adults

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

In a multicenter phase 2 trial BGB-3111-206 (NCT03206970) in the treatment of patients with relapsed or refractory (R/R) MCL with zebutinib, the ORR was 83.

Among the 118 MCL patients who had received at least one treatment in the past, 13.

The overall safety data of Baiyueze® comes from 779 patients with B-cell malignant tumors who have received Baiyueze® in multiple clinical trials.

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

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 multiple indications in the United States, China, Australia, Canada and other international markets, and is currently being further developed to support more marketing approvals worldwide

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
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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 companies including Amgen, Biotech, EUSA Pharma, Mirati Therapeutics, Seagen and Zymeworks to meet the current unmet medical needs of the world 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
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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
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The company's extensive drug portfolio currently includes more than 40 clinical drug candidates, through the strengthening of the company's independent competitiveness and cooperation with other companies
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We are committed to accelerating the development of existing diversified and innovative drug pipelines, and hope to comprehensively improve access to drugs for more than 2 billion people around the world by 2030
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BeiGene has built a huge team of more than 7,000 people on five continents around the world
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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 of Baiyueze® in Australia, the Asia-Pacific region and other markets And commercialization plans, the potential business opportunities of BaiGene, the plan to increase the availability of BaiGene in Australia, the potential clinical benefits of BaiGene, and the The plans, commitments, ambitions and goals of BeiGene mentioned under the subtitle of "BeiGene"
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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] BRUKINSA Australia Product Information.
Available at https:// Accessed October 2021.

[2] https:// Accessed August 2021.

[3] https:// August 2021.

Source: BeiGene (Beijing) Biotechnology Co.
, Ltd.