BeiGene Announces Acceptance by Swissmedic of Marketing Authorization Application for BRUKINSA® (Zanubrutinib) in Waldenström’s Macroglobulinaemia

BASEL, Switzerland--(BUSINESS WIRE)--$BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM). Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic.

Swissmedic, the Swiss Agency for Therapeutic Products, reviews new products for market authorization. Within this process, Swissmedic evaluates a product’s quality, safety, and effectiveness through clinical trial data.

Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: “The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer.”

The MAA is supported by data from the randomized Phase 3 ASPEN clinical trial (NCT03734016), evaluating zanubrutinib compared to ibrutinib in adult patients with WM.¹

The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.

About Waldenström’s Macroglobulinemia

WM is a rare lymphoma representing approximately 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.² The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.³ Throughout Europe, the estimated incidence rate of WM is approximately 7 for every 1 million men and 4 for every 1 million women.⁴

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is currently approved in several regions for various indications.¹ To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of approximately 7,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

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 filing and potential approval of a marketing authorization application for BRUKINSA in Switzerland, the potential for BRUKINSA to provide clinical benefit to patients, BeiGene's advancement, anticipated clinical development, regulatory milestones and commercialization of BRUKINSA, and BeiGene’s plans, commitments, aspirations and goals under the heading “About BeiGene”. You should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. 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.

* BRUKINSA is currently approved:
- For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)
- For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)^b
- For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)^b
- For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021)
- For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021)
- Registered and reimbursed for the treatment of MCL in patients who have received at least one prior therapy (Israel, April 2021)
- For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)^b
- For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021)

^a Approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
^b Approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

References:

¹ Tam CS, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. October 2020. 136(18): 2038-2050.
² Lymphoma Research Foundation. Getting the Facts: Waldenström Macroglobulinemia. Accessed July 2021. Available at https://lymphoma.org/wp-content/uploads/2020/09/LRF_Factsheet_Waldenstro%CC%88m-Macroglobulinemia_090920.pdf.
³ Lymphoma Research Foundation. Accessed July 2021. Available at https://lymphoma.org/aboutlymphoma/nhl/wm/.
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.

European Office
BeiGene Switzerland GmbH
Aeschengraben 27, 21^st Floor
4051 Basel, Switzerland
+41 61-685-1900
MedicalInformationEU@beigene.com

Investor Contact
Gabrielle Zhou
+86 10-5895-8058
ir@beigene.com

Media Contact
Liza Heapes or Vivian Ni
+1 857-302-5663 or +1 857-302-7596
media@beigene.com