BeiGene announces that Baiyueze(R) (Zebutinib) has been approved for the first time in Australia for the treatment of Fahrenheit's macroglobulinemia

This is the second approval recently obtained in the Asia-Pacific region following the approval of Baiyueze® in Singapore on October 1 for the treatment of mantle cell lymphoma

This approval is based on the results of the head-to-head ASPEN study of Baiyueze® versus ibrutinib in Fahrenheit's macroglobulinemia, which includes Australia

Beijing, China, Sydney, Australia and Cambridge, Massachusetts, October 8, 2021/PRNewswire/ - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) is a global biotechnology company The company focuses on the development and commercialization of innovative drugs worldwide

In addition, Baiyueze® has recently been approved by the Singapore Health Sciences Agency (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past

Professor Con Tam (Bachelor of Internal Medicine and Surgery, Doctor of Medicine), the principal investigator of the Baiyueze® clinical project and the head of the low-grade lymphoma and chronic lymphocytic leukemia disease group of the Peter MacCallum Cancer Center in Australia, said: "BTK inhibition is the treatment of WM patients.

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 2

David Young, head of the Australian WMozzies organization, commented: “Although WM is a slowly progressing lymphoma, not all patients can respond well to existing treatment options, and many patients have discontinued treatment due to adverse reactions.

BeiGene has submitted an application for reimbursement of Bai Yue Ze® to the Pharmaceutical Benefits Advisory Committee of Australia (PBAC)

Dr.

"The approval of Bejoyze® in Australia and the recent approval in Singapore signify the further expansion of Bejoyze® in the Asia-Pacific region

The marketing authorization of Baiyueze® for the treatment of WM in Australia is based on the effectiveness of the ASPEN trial

In the ASPEN trial, a total of 101 WM patients were randomly assigned to receive Baiyueze® treatment, and 5% of the patients discontinued treatment due to adverse events, including cardiac hypertrophy, neutropenia, plasma cell myeloma, and subdural hemorrhage

The overall safety profile of Baiyueze® is based on the combined data of 779 patients with B-cell malignant tumors who have received Baiyueze® in 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 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 had received at least one treatment in the past* 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 (CLL) who had received at least one treatment in the past.

At present, in addition to the United States and China, a total of more than 30 Baiyueze® has completed the submission of relevant listing applications for multiple indications, covering the European Union and more than 20 other countries

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

**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
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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
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The company's global clinical research and development team has about 2,300 people, and the team is still expanding
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This team is currently supporting more than 90 clinical studies worldwide and has recruited more than 13,000 patients and healthy subjects
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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
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The company pays special attention to the targeted therapy of hematological tumors and solid tumors and tumor immunotherapy, and focuses on single-drug and combination therapies
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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 and other international markets), Baizean® (which can effectively avoid Fc -γ receptor-binding anti-PD-1 antibody has been approved for marketing in China) and Baihuize® (approved for marketing in China)
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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 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
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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 broad drug portfolio currently includes more than 40 clinical drug candidates
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The company accelerates the development of diversified and innovative drug pipelines by strengthening independent research and development capabilities and cooperation
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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 huge team of more than 7,000 people on five continents around the world
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For more information, please visit
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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 and commercialization plans of Baiyueze® in Australia, Singapore, the Asia-Pacific region and other markets.
The potential commercialization opportunities of Baiyueze®, the accessibility of Baiyueze® to Australian patients, the potential of Baiyueze® to become a "best-in-class" BTK inhibitor, the potential benefits to patients, and the The plans, commitments, ambitions and goals of BeiGene under the headings "About BeiGene Oncology" and "About BeiGene"
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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 new coronary pneumonia on BeiGene’s clinical development, supervision, commercial operations and other businesses; BeiGene discussed more fully in the "Risk Factors" section of the most recent quarterly report on Form 10-Q Various risks; and discussions on potential risks, uncertainties and other important factors in BeiGene's subsequent submission to the US 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:// Accessed August 2021.

Source: BeiGene