BeiGene Announces that Baiyueze(R) (zanubrutinib) has been accepted by the U.S. Food and Drug Administration for a New Indication Marketing Authorization Application for the Treatment of Chronic Lymphocytic Leukemia

<>/* Style Definitions */ span.

FDA target date for decision on this application under the Prescription Drug Filer Fees Act is October 22 , 2022

BEIJING, China and CAMBRIDGE, Mass.
, Feb.
22, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a science-based company A global biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and improve access to medicines for patients around the world
.

The company announced today that the U.

Weijuan Huang, MD, Chief Medical Officer of Hematology at BeiGene, said: "We are excited to announce that the FDA has accepted the marketing authorization application for Baiyaze® for the treatment ^of CLL ^.
Another important milestone in the project
.

Baiyueze® demonstrated an investigator-assessed overall response rate (ORR) superior to ^ibrutinib in the ALPINE study in relapsed/refractory patients, and in the initial The SEQUOIA study of CLL patients demonstrated better progression-free survival (PFS) than chemoimmunotherapy, which shows that Baiyueze® is ^expected to improve the treatment effect of CLL patients

The sNDA filing for CLL/SLL is based on 2 pivotal, randomized Phase 3 studies and 8 supporting studies in B-cell malignancies
.

Among them , the two global phase 3 trials of ^Baiyueze® in the treatment of CLL/SLL are: ALPINE study (NCT03734016), which compared Baiyueze® with ibrutinib ^for the treatment of relapsed/refractory (R/R ) patients; and the SEQUOIA ( ^NCT03336333 ) study comparing Baiyueze® with bendamustine combined with rituximab in treatment-naïve (TN) patients

"While previously approved BTK inhibitors have benefited many patients with CLL," said Jennifer R.
However, not all patients can achieve good clinical remission, and many patients cannot tolerate previously approved BTKi treatment regimens, so patients still have persistent unmet clinical needs
.

CLL patients treated with Baiyueze® were generally well tolerated, had a low incidence of atrial fibrillation, and demonstrated strong efficacy compared with ibrutinib and ^{chemoimmunotherapy}

About Chronic Lymphocytic Leukemia 

Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults
.

CLL accounts for about a quarter of new cases of leukemia, with more than 21,000 new cases in the United States in 2021 ^[1]

^About Baiyueze®

Baiyueze® ( ^zanubrutinib ) is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) independently developed by BeiGene scientists.
It is currently undergoing extensive clinical trials around the world as a single drug.
and in combination with other therapies to treat a variety of B-cell malignancies
.

Since new BTK is continuously synthesized in the human body, Baiyueze® is designed to achieve complete and sustained inhibition of ^BTK protein by optimizing bioavailability, half-life and selectivity

Baiyueze® ^has previously been approved for the treatment of three indications in the United States: November 2019, approved for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one prior therapy; August 2021 , approved for the treatment of adult patients with Waldenström macroglobulinemia (WM); and September 2021, approved for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20 therapy *
.

To date, Baiyueze® ^has received more than 20 approvals in more than 40 countries and regions including the United States, China, the European Union and the United Kingdom, Canada, Australia and other international markets
.

At present, there are still more than 40 drug regulatory applications under review worldwide

* Accelerated approval for this indication based on overall response rate
.

Subsequent formal approval for this indication will be contingent upon verification and description of clinical benefit in confirmatory trials
.

About BeiGene Oncology

BeiGene continuously promotes the research and development of best-in-class or first-in-class clinical drug candidates through independent research and development or in collaboration with like-minded partners, and is committed to providing effective, accessible and affordable medicines to patients around the world
.
The company's global clinical research and development team of approximately 2,900 people is still growing, and is currently supporting more than 100 ongoing or in-progress clinical studies worldwide, with more than 14,500 patients and healthy subjects enrolled
.
The company has a deep product pipeline and a wide range of experiments.
The experiments have covered more than 45 countries/regions around the world, and all of them are led by the company's internal team
.
The company is deeply engaged in the development of targeted therapy and tumor immunotherapy for hematological and solid tumors, while focusing on the exploration of monotherapy and combination therapy
.
At present, three drugs independently developed by BeiGene have been approved for marketing: ^Baiyueze® (BTK inhibitor, which has been approved for listing in the United States, China, EU, Canada, Australia and other international markets) , Baizean® ⁽ Anti-PD-1 antibody that can effectively avoid Fc-gamma receptor binding, has been approved for marketing in China) and Baihui Ze® ⁽ has been approved for marketing in China)
.
 

At the same time, BeiGene is also working with other innovative companies to jointly advance the research and development of innovative therapies to meet global health needs
.
In China, BeiGene is selling a number of oncology drugs licensed by Amgen, Bristol-Myers Squibb, EUSA Pharma, and Bio-Tech
.
The company is also working with companies including Mirati Therapeutics, Seagen and Zymeworks to better address current unmet medical needs worldwide
.
 

In January 2021, BeiGene and Novartis announced a collaboration, granting Novartis the co-development, production and commercialization of BeiGene's anti-PD-1 antibody Baizean® in North America, Europe and ^Japan
.
Based on this fruitful collaboration, the FDA is reviewing a new drug marketing authorization application (BLA) for ^Baizean , while BeiGene and Novartis announced two new agreements in December 2021, granting Novartis a joint Develops, manufactures and commercializes BeiGene's TIGIT inhibitor ociperlimab (currently in Phase 3 clinical development) and grants rights to 5 approved Novartis oncology products in BeiGene's portfolio in designated regions in China
.

About BeiGene

BeiGene is a global, science-based biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and improve access to medicines for patients around the world
.
The company's extensive drug portfolio currently includes more than 40 clinical 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 worldwide by 2030
.
BeiGene has built a team of more than 8,000 people on five continents
.
For more information, please visit http:// .
 

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 , Announcements on regulatory filings and potential commercialization, the potential of Baiyaze® ^to deliver improved clinical benefit and safety benefits to patients, the potential commercialization opportunities of ^Baiyueze® , and in "About BeiGene Oncology" and BeiGene's plans, vision, ambitions, and goals as referred to under the subtitle "About BeiGene
.
" Actual results may differ materially from forward-looking statements as a result of various important factors
.
These factors include the risk of: BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; clinical results of drug candidates that may not support further development or marketing approval; actions by regulatory authorities that may affect the outcome of clinical trials Initiation, timelines and progress, and drug marketing approvals; BeiGene's ability to achieve commercial success with its 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, manufacturing, and other services; BeiGene's limited experience in obtaining regulatory approval and commercializing pharmaceutical products, and its access to further working capital to complete drug candidate development and commercialization and remain profitable capabilities; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercialization, and other businesses; BeiGene’s more comprehensive coverage in the “Risk Factors” section of its most recent quarterly report on Form 10-Q risks discussed; and discussions of potential risks, uncertainties and other important factors in BeiGene's subsequent filings with the SEC
.
All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law
.

references

1.
National Cancer Institute.
Available here: https://seer.
cancer.
gov/statfacts/html/clyl.
html

2.
American Cancer Society.
Cancer Facts & Figures 2021.
Atlanta ; American Cancer Society; 2021.
Available here: https:// -facts-figures-2021.
html

3.
Global Burden of Disease Cancer Collaboration.
Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2017.
JAMA Oncol.
2019 ;5(12):1749-1768.

4.
National Cancer Institute.
Chronic Lymphocytic Leukemia Treatment (PDQ®) – Patient Version.
Available here: https://

5.
Haselager MV et al.
Proliferative Signals in Chronic Lymphocytic Leukemia; What Are We Missing? Front Oncol.
2020; 10: 592205.

6.
Cancer Support Community.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Available here: https:// .