BeiGene receives positive opinions from the European Medicines Agency's Committee for Human Medicines (CHMP) on the treatment of adult patients with Fahrenheit's macroglobulinemia

Beijing, China, Basel, Switzerland and Cambridge, Massachusetts, September 17, 2021/PRNewswire/ - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) today announced the European Medicines Management The Committee on Medicines for Human Use (CHMP) of the Agency (EMA) recommends approval of Baiyueze® (Zebutinib) for adult patients with Waldenstrom's macroglobulinemia (WM) who have previously received at least one treatment, or as an unsuitable chemical First-line treatment options for immunotherapy of WM patients

Professor Christian Buske, medical director of the Comprehensive Cancer Center of Ulm University Hospital in Germany and one of the investigators of the ASPEN trial, said: "Although BTK inhibitors have become a promising therapy for WM, they have low response rates or strong side effects.

CHMP’s positive opinions are based on the results of the ASPEN Phase 3 randomized clinical trial.

Compared with ibrutinib, Baiyueze ® shows better safety characteristics, and the incidence of specific adverse events is lower, including atrial fibrillation/atrial flutter (Baiyueze ® 2.

Dr.

Gerwin Winter, senior vice president of BeiGene and head of European commercialization, said: "We already have a strong team in Europe and have the opportunity to further cooperate with European researchers who have participated in the Baiyueze® trial.

After CHMP announces its positive opinions, the European Commission will review BeiGene’s listing application and is expected to issue a final review decision within 67 days after receiving the CHMP’s opinions

About Fahrenheit Macroglobulinemia

Waldenstrom's macroglobulinemia (WM) is a rare lymphoma, accounting for about 1% of all non-Hodgkin's lymphomas, and usually progresses slowly after diagnosis [2]

About the ASPEN test

This randomized, open, multi-center ASPEN Phase 3 clinical trial (NCT03053440) aims to evaluate ibrutinib versus ibrutinib in the treatment of relapsed/refractory (R/R) and naive (TN) Fahrenheit macroglobulin Patients with hememia (WM)

The trial included two cohorts.

Random cohort 1 enrolled 102 patients treated with Zebutinib, of which 83 were relapsed or refractory (R/R) patients and 19 were naive (TN) patients; Ibrutinib group was enrolled 99 patients were collected, of which 81 were R/R patients and 18 were TN patients

The results of cohort 2 were previously announced at the 24th European Hematology Association (EHA) Annual Meeting, with an overall response rate (ORR) of 80.

About Baiyueze® (Zebutinib)

Baiyueze® 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, there are a total of more than 30 Baiyueze® related listing applications submitted for multiple indications, covering the United States, China, the European Union and more than 20 other countries or regions

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

**This indication was approved with conditions
.
Full approval for this indication will depend on the results of ongoing confirmatory randomized, controlled clinical trials
.

About BeiGene Oncology

BeiGene continues to promote the 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
.
The company's global clinical research and development team has about 2,300 people, and the team is still expanding
.
This team is currently supporting more than 90 clinical studies worldwide and has recruited more than 13,000 patients and healthy subjects
.
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
.
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
.
At present, three drugs independently researched and developed by BeiGene have been approved for the market: Baiyueze® (BTK inhibitor, which has been approved for marketing in the United States, China, Canada and other international markets), Baizian® (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)
.

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
.
In China, BeiGene is selling a variety of oncology drugs authorized by Amgen and Bristol-Myers Squibb
.
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
.
BeiGene has also reached a cooperation with Novartis, authorizing Novartis to develop, produce and commercialize Bezeran® in North America, Europe and Japan 
.

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
.
The company's broad drug portfolio currently includes more than 40 clinical drug 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 around the world by 2030
.
BeiGene has built a huge team of more than 7,000 people on five continents around the world
.
For more information, please visit
.

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 regarding the future development and potential of Baiyueze® in the EU and other markets The commercialization of Baiyueze® has the potential to become the best-in-class BTK inhibitor, as well as the statement of the potential clinical benefits, safety advantages and business opportunities of Baiyueze®
.
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 effectiveness 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 may affect the clinical trials Initiation, 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 of its drugs and technologies; BeiGene's reliance on third parties for drug development, production and other services; BeiGene's limited operating experience and its ability to obtain further working capital to complete the development and commercialization of drug candidates; The impact of clinical development, commercialization, operations, and other businesses of Jeshenju; and the various risks discussed more fully in the "Risk Factors" section of the most recent quarterly report of BeiGene in the 10-Q form of the latest quarterly report; and BeiGene Discussion of potential risks, uncertainties and other important factors in the subsequent submission to the US Securities and Exchange Commission
.
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
.

references:

[1].
Tam, et al.
A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study.
Blood.
October 2020.
136;18: 20382050.

[2].
Lymphoma Research Foundation.
Getting the Facts: Waldenström Macroglobulinemia.
Available at https://lymphoma.
org/wp-content/uploads/2020/09/LRF_Factsheet_Waldenstro%CC%88m-Macroglobulinemia_090920.
pdf.
Accessed April 2021.

[3].
Lymphoma Research Foundation.
Available at https://lymphoma.
org/aboutlymphoma/nhl/wm/.
Accessed December 2020.

[4].
Buske, C, et al.
Treatment and outcome patterns in European patients with Waldenström's macroglobulinaemia: a large, observational, retrospective chart review.
The Lancet Haematology 2018; 5: e0299-309.

Source: BeiGene