BeiGene announced that a new indication for zebutinib ® for the initial treatment of Fahrenheit macroglobulinemia has been accepted in China

China's State Drug Administration (NMPA) approved Baiyueze ® in June 2021 for the treatment of patients with relapsed or refractory Fahrenheit macroglobulinemia (WM).

The market application for the new indications is based on the results of the ASPEN test, which is expected to expand the scope of application of Baiyueze ® to the first-line WM

BEIJING, CHINA AND CAMBRIDGE, MASSACHUSETTS, Jan. 20, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a global, science-based biotechnology company focused on developing and commercializing innovative drugs worldwide to improve treatment outcomes and access to patients worldwide. The Company today announced that the Drug Evaluation Center (CDE) of the State Drug Administration of China (NMPA) has accepted a new indication for the marketing of its BTK inhibitor, Zebutinib ®, for the treatment of adult patients with Fahrenheit macroglobulinemia (WM) (sNDA).

Dr. Huang Weijuan, Chief Medical Officer of BeiGene Hematology, said: "It is good news for us that the sNDA application has also been accepted by the NMPA following the approval of Baiyueze ® for the treatment of patients with recurrent or refractory Warfarin Macroglobulinemia (WM). This means that once approved, more people with Fahrenheit macroglobulinemia in China will have the opportunity to use the drug. The ASPEN trial showed that Baiyueze ® is a safe and effective treatment option for patients with WM, with a lower risk of cardiovascular events such as atrial fibrillation. With the support of ASPEN trial data, Baiyueze ® has been approved for the treatment of WM patients in the United States, Canada, Australia and the European Union, and we look forward to continuing discussions with CDE to provide this drug with 'best-in-class' potential to more WM patients in China." ”

The sNDA application is based on data from the ASPEN trial, a randomized, open-label, multicenter Phase 3 clinical trial (NCT03053400) comparing data from Baiyueze ® and ibrutinib for the treatment of patients with relapse/refractory (R/R) or initial (TN) WM.

The Independent Review Committee (IRC) assessed the revised remission criteria (Treon 2015) of the 6th International Symposium on Fahrenheit Macroglobulinemia (IWWM-6) as follows: a combination of 28% (95% CI: 20,38) in the Ibutinib ® group compared with 19% (95% CI: 12), in the Ibrutinib group. 28) Although the difference between the two sets of data did not reach statistical significance (p=0.09), Baiyueze ® showed higher VGPR rate data, and the quality of mitigation showed an improvement trend[1]

In the ASPEN trial, Pfizer ® achieved more advantageous safety data compared with ibutinib, with a lower incidence of specific adverse events, including atrial fibrillation/atrial flutter (2% vs. 15%) and major bleeding (6% vs. 9%) In 101 patients with WM treated with Blitinib ®, 4% of patients discontinued treatment due to adverse events and 14% of patients lowered the dose due to adverse events[4]

About Fahrenheit macroglobulinemia Fahrenheit macroglobulinemia is a rare indolent lymphoma that accounts for less than 2% of patients with non-Hodgkin lymphoma (NHL)[1] The disease is usually more common in older people, mainly found in the bone marrow, but may also involve lymph nodes and spleen[2] In China, there are about 88,200 new cases of lymphoma each year, of which about 91% are NHL, which means that there are about 1,000 new cases of WM per year in the mainland[3] About Baiyueze ® (Zebutinib)

Baiyueze ® (Zebutinib) is a Small Molecule Inhibitor independently developed by BeiGene scientists Bruton's Tyrosine Kinase (BTK), which is currently undergoing extensive clinical trial projects around the world, as a single drug and in combination with other therapies to treat a variety of B cell malignancies Because the new BTK will continue to be synthesized in the human body, Baiyueze ® is designed to achieve complete access to the BTK protein by optimizing bioavailability, half-life and selectivity. Continuous inhibition With pharmacokinetics that differentiates 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 patients with adult sleeve cell lymphoma (MCL) who had received at least one treatment in the past*
• In June 2020, Baiyueze ® was approved in China for the treatment of MCL patients who had received at least one previous treatment**
• In June 2020, Baiyueze ® was approved in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who had received at least one treatment before**
• 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 patients with Fahrenhet macroglobulinemia (WM).
• In June 2021, Baiyueze ® was approved in China for the treatment of WM adult patients who had received at least one treatment before**
• 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 had received at least one treatment before**
• In August 2021, Baiyueze ® was approved in Brazil for the treatment of adult MCL patients who had 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 marginal lymphoma (MZL) patients who had previously received at least one anti-CD20 therapy**
• In October 2021, Baiyueze ® was approved in Singapore for the treatment of adult MCL patients who had previously received at least one treatment
• In October 2021, Baiyueze ® was approved in Israel for the treatment of adult MCL patients who had previously received at least one treatment
• In October 2021, Baiyueze ® was approved in Australia for the treatment of adult WM patients who have previously received at least one treatment or as a first-line treatment option for patients who are not suitable for chemotherapoimmunotherapy WM
• In October 2021, Baiyueze ® was approved in Australia for the treatment of adult MCL patients who had previously received at least one treatment.
• In October 2021, Baiyueze ® was approved in Russia for the treatment of adult MCL patients who had previously received at least one treatment
• In November 2021, Baiyueze ® was approved in Saudi Arabia for the treatment of adult mantle cell lymphoma (MCL) patients who had received at least one previous treatment;
• In November 2021, Baiyueze ® was approved in the European Union, Iceland, Liechtenstein and Norway for the treatment of adult patients with Fahrenheit macroglobulinemia (WM) who had previously received at least one therapy, or as a first-line therapy for the treatment of patients who were not suitable for chemoimmunotherapy;
• In December 2021, Baiyueze ® was approved in the UK for the treatment of adult patients with Fahrenheit macroglobulinemia (WM) who had previously received at least one therapy, or as a first-line therapy for the treatment of patients who were not suitable for chemotherapy and immunotherapy;
• In December 2021, Baiyueze ® was approved in Ecuador for the treatment of adult mantle cell lymphoma patients who had previously received at least one therapy.

To date, more than 30 marketing applications for multiple indications have been submitted, covering the United States, China, the European Union and more than 20 other countries or regions.

*Accelerated approval for this indication based on total response rate (ORR) Full approval for this indication will depend on the validation and description of clinical benefit in the validated trial.

**Conditional approval for this indication Full approval for this indication will depend on the results of a confirmatory randomized, controlled clinical trial ongoing.

About BeiGene oncology

BeiGene continues to promote best-in-class or first-class clinical drug candidate development through independent research and development or with like-minded partners, and is committed to providing influential, accessible and affordable drug companies around the world with a global clinical research and development team of about 2,300 people, and the team size is still expanding, this team is currently supporting more than 90 clinical studies worldwide. More than 13,000 patients and healthy subjects have been recruited 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 around the world At present, three drugs independently 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), Bai Zean ® (anti-PD-1 antibody that can effectively avoid Fc-γ receptor binding, Approved for listing in China) and Parkway (® approved for listing in China) BeiGene has a team that pursues high quality and innovation, is based on science and medicine, and has established a leading position in China, creating a large-scale business team focused on oncology

At the same time, BeiGene is also working with other innovative companies to promote the research and development of innovative therapies to meet global health needs in China, and BeiGene is selling a number of oncology drug companies licensed by Amgen and Bristol-Myers Squibb through cooperation with companies including Amgen, BIT, EUSA Pharma, Mirati Therapeutics, Seagen and Zymeworks. BeiGene has also partnered with Novartis to license Novartis to develop, produce and commercialize Bavar ® in North America, Europe and Japan.

About BeiGene

BeiGene is a science-based global biotechnology company focused on developing innovative, affordable drugs to improve treatment outcomes and access for patients around the world Currently the company's broad drug portfolio includes more than 40 clinical drug candidates to accelerate the advancement of diversity by strengthening independent R&D capabilities and collaboration. Innovative Drug Pipeline Development We are committed to comprehensively improving drug accessibility for more than 2 billion people worldwide by 2030 BeiGene has built a team of more than 8,000 people on five continents around the world For more information, please visit.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential clinical benefits and advantages of Baiyueze ® compared to other BTK inhibitors, the progress of the BeiGene program, and The expected clinical development, pharmaceutical policy milestones and commercialization processes of Baiyueze ® ® by BeiGene Potential business opportunities, programs to improve ® accessibility in China, Best-in-class ® BTK inhibitors, potential ® clinical benefits for patients, and the beigene plans, commitments, ambitions and goals mentioned under the subtitles "BeiGene Oncology" and "About BeiGene" due to various important factors, Actual results may differ materially from forward-looking statements These factors include the risk that BeiGene's ability to demonstrate the efficacy and safety of its drug candidates may not support further development or marketing approval actions of the NMPA may affect the commencement of clinical trials. Timelines and progress and drug listing approvals BeiGene's ability to achieve commercial success of marketed drugs and drug candidates (if approved) BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technologies BeiGene's reliance on third parties for drug development, production and other services BeiGene's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products, and its ability to secure further working capital to complete drug candidate development and realization and remain profitable Impact of the COVID-19 pandemic on BeiGene's clinical development, regulatory, commercial operations and other businesses The types of risks that BeiGene discussed more fully in the "Risk Factors" section of the most recent quarterly report on Form 10-Q and the potential risks in BeiGene's post-period filings with the U.S. Securities and Exchange Commission, Discussion of Uncertainties and Other Material Factors All information in this press release is limited to the date of this press release, and BeiGene has no obligation to update such information except as required by law.

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