The US FDA granted accelerated approval to Baiyueze® (Zebutinib) for the treatment of relapsed or refractory marginal zone lymphoma

This is the third approval of Baiyueze® in the FDA and the first approval in the field of marginal zone lymphoma.

After Baiyueze® monotherapy, 20% of patients achieved complete remission

Baiyueze® is generally well tolerated and is consistent with its known safety characteristics

Beijing, China and Cambridge, Massachusetts, September 15, 2021/PRNewswire/ - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) is a global biopharmaceutical company focused on Develop and commercialize innovative drugs worldwide
.

The company announced today that the U.

This accelerated approval is based on overall response rate (ORR) results
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The subsequent full approval of this indication will depend on whether the confirmatory test can further confirm the patient's clinical benefit

Weijuan Huang, Chief Medical Officer of BeiGene, said: "We are very pleased to see the FDA approving the use of BaiGene for the treatment of previously treated patients with marginal zone lymphoma.
This is an important milestone and a dedicated BeiGene.
The results of the joint efforts of the team, researchers, and the patients participating in the trial and their families.
The results of the
MAGNOLIA study once again confirmed that the highly selective structural design of Baiyueze® can be transformed into a better curative effect for patients
.

In addition.
, We are continuously evaluating Baiyueze® through an extensive global clinical development project, which will enable us to have a deeper understanding of this potentially best-in-class BTK inhibitor and its impact on patients

As the main investigator of the MAGNOLIA trial, Dr.
Stephen Opat, MD, Head of Hematology at Monash University in Australia and Director of Clinical Hematology at Monash Hospital, commented: "BTK plays a key role in the B cell receptor signaling pathway, and is also a border zone lymph node.
A major cause of tumor formation
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In the MAGNOLIA trial, Baiyueze® showed an impressive total response rate and complete response rate.

Meghan Gutierrez, CEO of the American Lymphoma Research Foundation, commented: "The approval of Baiyueze® can bring a new treatment option for patients with relapsed or refractory marginal zone lymphoma, and improve the treatment of patients.
The result brings new hope
.

"

The FDA approval is based on the effectiveness of two single-arm clinical trials.
The primary endpoints of these two trials are ORR evaluated by the Independent Review Committee (IRC) based on the 2014 Lugano classification criteria
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A multi-center, pivotal Phase 2 MAGNOLIA clinical trial (NCT03846427) evaluated the efficacy of Baiyueze® in R/R MZL patients who have received at least 1 line of anti-CD20 therapy
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A total of 66 patients were enrolled in the study, 26 of which were extranodal subtypes, 26 were lymph node subtypes, 12 were splenic subtypes, and 4 were unknown subtypes

Another global Phase 1/2 study BGB-3111-AU-003 (NCT02343120) evaluated 20 patients with MZL, including 9 extranodal subtypes, 5 lymph node subtypes, and 6 splenic subtypes
.

Based on the evaluation of CT scan, the ORR obtained by Baiyueze® was 80% (95% CI: 56, 94), and the CR rate was 20%

The most common (≥30%) adverse reactions of Baiyueze®, including abnormal detection data in 847 patients, are neutropenia, upper respiratory tract infection, thrombocytopenia, bleeding, lymphopenia, Skin rash and musculoskeletal pain
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The recommended dosage of Baiyueze® is 160 mg twice daily or 320 mg once daily, either on an empty stomach or after meals
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The dosage can be adjusted according to the adverse reaction.

About Baiyueze® (Zebutinib)

BRUKINSA® (BRUKINSA®, 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 agent and 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
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With its differentiated pharmacokinetics from other approved BTK inhibitors, Baiyueze® can inhibit the proliferation of malignant B cells in multiple disease-related tissues
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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.
) 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.
In March 2021, Baiyueze® was approved in Canada Approved for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM) 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 had received at least one treatment in the past** In July 2021, Baiyueze® was approved in Canada for the treatment of at least one type of treatment in the past.
Adult MCL patients with three treatments** In July 2021, Baiyueze® was approved in Chile for the treatment of adult MCL patients who had received at least one treatment in the past August 2021, Baiyueze® was approved for use in Brazil Treatment of adult MCL patients who have received at least one treatment in the past 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 at least Adult patients with marginal zone lymphoma (MZL) who received an anti-CD20 treatment

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
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*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
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**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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The 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, and provides 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: Beyzean® (BTK inhibitor, which has been approved for marketing in the United States, China, Canada and other international markets), Bezean® (which can effectively avoid Fc -γ receptor-binding anti-PD-1 antibody, has been approved for marketing in China) and Baihuize® (PARP inhibitor, has been 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 also cooperates with many 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 biopharmaceutical company, focusing on the development of innovative and affordable drugs, aiming to improve treatment outcomes and access to drugs for patients around the world
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Currently, the company's broad drug portfolio 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 worldwide 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
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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 BeiGene's promotion plan and expected clinical development, pharmaceutical regulatory milestones, and commercialization of BaiGene Progress, the potential to bring improved clinical benefits to patients, and BeiGene’s plans, commitments, ambitions and goals under the headings "About BeiGene Oncology" and "About BeiGene"
.
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 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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Source: BeiGene (Beijing) Biotechnology Co.
, Ltd.