BeiGene to Demonstrate Strength of Hematology Portfolio and Pipeline at European Hematology Association 2022 Congress

Data from four pivotal trials continue to build evidence base for BRUKINSA^� (zanubrutinib) in B-cell malignancies

Pipeline showing promise with early data for BGB-11417, a BCL-2 inhibitor, as monotherapy and in combination with zanubrutinib

CAMBRIDGE, Mass., BEIJING & BASEL, Switzerland–(BUSINESS WIRE)–$BGNE #BeiGene–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced 20 presentations from the Company’s global clinical development programs in hematologic malignancies at the European Hematology Association (EHA) 2022 Hybrid Congress being held June 9 – 12, 2022 in Vienna, Austria.

“With an oral presentation for the ROSEWOOD trial of zanubrutinib in follicular lymphoma and 19 poster presentations describing clinical data and patient-focused endpoints, our scientific presence at EHA demonstrates BeiGene’s commitment to improving patient-care through innovative research,” said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. “We look forward to sharing data pointing to the promise of our pipeline in areas of high unmet need for people with hematologic malignancies.”

BeiGene presentation highlights

Zanubrutinib

• ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial
• ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia
• SEQUOIA: Patient-reported outcomes from a Phase 3 randomized study of zanubrutinib versus bendamustine plus rituximab (br) in patients with treatment-naïve (tn) chronic lymphoctic leukemia (CLL)/ small lymphocytic lymphoma (SLL)
• ALPINE: Health-related quality of life outcomes associated with zanubrutinib vs ibrutinib monotherapy in patients with relapsed/refractory (rr) CLL/SLL: results from the randomized Phase 3 ALPINE trial

Early-stage pipeline

• Two poster presentations for BCL-2 inhibitor BGB-11417
  • Monotherapy and combination with zanubrutinib: Phase 1 data in CLL, non-Hodgkin’s lymphoma and acute myeloid leukemia (AML)
  • Monotherapy: preliminary safety and efficacy in AML

Presentation details

Abstract Title and Number	Session/Location	Date and Time (all times CEST)	Presenting Author
BeiGene Hematologic Malignancies Clinical Data at EHA2022 Hybrid Congress
Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial   Abstract Number: S205	Session Title: Indolent and mantle cell lymphoma; Session room: Hall C1	Saturday, June 11 11:30 AM – 12:45 PM	Pier L. Zinzani, M.D., Ph,D.
ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib vs ibrutinib in patients with Waldenström macroglobulinemia (WM)   Abstract Number: P1161		Friday, June 10 16:30 – 17:45 PM	Alessandra Tedeschi, M.D.
Results of a Phase 2 expanded access study of zanubrutinib in patients with Waldenström macroglobulinemia   Abstract Number: P1160		Friday, June 10 16:30 – 17:45 PM	Jorge J. Castillo, M.D.
Zanubrutinib in older patients (pts) with relapsed/refractory marginal zone lymphoma: subgroup analysis of the Magnolia study   Abstract Number: P1162		Friday, June 10 16:30 – 17:45 PM	Prof. Stephen Opat
Tislelizumab, a PD-1 inhibitor for relapsed/refractory mature T/NK-cell neoplasms: results from a Phase 2 study   Abstract Number: P1239		Friday, June 10 16:30 – 17:45 PM	Emmanuel Bachy. M.D., Ph.D.
A Phase 1 study with the novel B-cell lymphoma 2 inhibitor BGB-11417 as monotherapy or in combination with zanubrutinib in patients with B-cell malignancies: preliminary data   Abstract Number: P687		Friday, June 10 16:30 – 17:45 PM	Prof. Stephen Opat
Preliminary safety and efficacy of BGB-11417, a potent and selective B-cell lymphoma 2 (BCL2) inhibitor, in patients with acute myeloid leukemia   Abstract Number: P590		Friday, June 10 16:30 – 17:45 PM	Prof. Jake Shortt
A Phase 1 first in-human study of BGB-16673, a Bruton tyrosine kinase protein degrader, in patients with B-cell malignancies (trial in progress)   Abstract Number: P686		Friday, June 10 16:30 – 17:45 PM	Constantine S. Tam, M.B.B.S., M.D., F.R.A.C.P., F.R.C.P.A.
Zandelisib on intermittent dosing as a single agent or in combination with rituximab or zanubrutinib in relapsed/refractory follicular lymphoma: results from a multi-arm Phase 1b study   Abstract Number: P1114		Friday, June 10 16:30 – 17:45 PM	Felipe Samaniego, M.D.
BeiGene Patient-Reported Outcomes (PRO), Real-World Evidence (RWE) and Health Economics & Outcomes Research at EHA2022 Hybrid Congress
Patient-Reported Outcomes from a Phase 3 Randomized Study of Zanubrutinib versus Bendamustine Plus Rituximab (BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)   Abstract Number: P662		Friday, June 10 16:30 – 17:45 PM	Paolo Ghia, M.D., Ph.D.
Health-Related Quality of Life Outcomes Associated With Zanubrutinib Versus Ibrutinib Monotherapy In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (RR CLL/SLL): Results from the Randomized Phase 3 ALPINE Trial   Abstract Number: P663		Friday, June 10 16:30 – 17:45 PM	Peter Hillmen, M.B., Ch.B., Ph.D.
Population-Wide Patterns of Care in Chronic Lymphocytic Leukemia in Australia: An Analysis of the Pharmaceutical Benefits Scheme Dataset   Abstract Number: P661		Friday, June 10 16:30 – 17:45 PM	Constantine Tam, M.B.B.S., M.D., F.R.A.C.P., F.R.C.P.A.
Real world evidence of impact of atrial fibrillation (AF) on clinical and economic outcomes in patients (pts) with chronic lymphocytic leukemia (CLL)   Abstract Number: P685		Friday, June 10 16:30 – 17:45 PM	Asher Chanan-Khan, M.B.B.S., M.D.
Real-world treatment patterns and comparative effectiveness of Bruton tyrosine kinase inhibitors (BTKi) in patients (pts) with mantle cell lymphoma (MCL)   Abstract Number: P1157		Friday, June 10 16:30 – 17:45 PM	Bijal D. Shah, M.D.
Real-world treatment (tx) patterns and economic burden of patients (pts) with Marginal Zone Lymphoma (MZL)   Abstract Number: P1158		Friday, June 10 16:30 – 17:45 PM	Bijal D. Shah, M.D.
BeiGene Online Only Abstracts at EHA2022 Hybrid Congress
Zanubrutinib in acalabrutinib-intolerant patients with B-cell malignancies   Abstract Number: PB1890		Online Only	Mazyar Shadman, M.D., M.P.H.
Efficacy of First-Line Treatment for Chronic Lymphocytic Leukemia: A Bayesian Network Meta-Analysis   Abstract Number: PB1888		Online Only	Asher Chanan-Khan, M.B.B.S., M.D.
Network Meta-Analysis of Progression Free Survival in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia   Abstract Number: PB1887		Online Only	Asher Chanan-Khan, M.B.B.S., M.D.
Population-Wide Patterns of Care in Mantle Cell Lymphoma in Australia: An Analysis of the Pharmaceutical Benefits Scheme Dataset   Abstract Number: PB2082		Online Only	Constantine Tam, M.B.B.S., M.D., F.R.A.C.P., F.R.C.P.A.
Treatment persistence and adherence to ibrutinib in patients with WM: a German claims data analysis   Abstract Number: PB2081		Online Only	Prof. Christian Buske

About BRUKINSA

BRUKINSA (zanubrutinib) 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 supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 45 countries and regions, including the United States, China, the EU, and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

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 over 8,000 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 BeiGene’s advancement, anticipated clinical development, regulatory milestones and commercialization of BGB-11417, BGB-16673, tislelizumab, zandelisib and zanubrutinib and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “About BeiGene.” 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 BeiGene’s clinical development, regulatory, commercial, manufacturing, 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.

Contacts

Investor Contact
Kevin Mannix

+1 240-410-0129

ir@beigene.com

Media Contact
Emily Collins

+1 201-201-4570

media@beigene.com