BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that clinical results and subgroup analyses from the Company’s robust lung cancer program will be presented at the European Society for Medical Oncology (ESMO) Congress 2021.

“We continue to make meaningful progress with our deep immuno-oncology portfolio, including our lung cancer program of seven Phase 3 trials in NSCLC. Driven by growing clinical insights, we are working to accelerate the development of tislelizumab in novel combinations in lung cancer, including with our internally discovered potent investigational anti-TIGIT antibody ociperlimab and therapeutic agents from collaborations, such as sitravatinib,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “In addition, our scientists are exploring new modalities for potential combinations with tislelizumab in lung cancer and other solid tumors, and with the ongoing Novartis collaboration, tislelizumab can be leveraged with their oncology pipeline for more combination opportunities. We plan to work to realize the therapeutic potential of this differentiated checkpoint inhibitor through combinations in various tumor types for patients worldwide.”

To learn more about BeiGene’s research and development and activities around ESMO, please visit https://beigenemedical.eu/.

Broad Lung Cancer Program Focused on Tislelizumab Combination Treatments

BeiGene is pursuing diverse mechanisms of action in combination with tislelizumab to complement targeting of the PD-1 pathway for potentially improved clinical outcomes or to overcome resistance associated with disease progression.

In NSCLC, many patients who have achieved a response to front-line anti-PD-1 antibody treatment eventually relapse due to resistance. Through its collaboration with Mirati Therapeutics, BeiGene is investigating the combination of tislelizumab and sitravatinib, a spectrum-selective tyrosine kinase inhibitor potentially capable of reversing immunosuppressive tumor microenvironment to overcome immune resistance. BeiGene is conducting a Phase 3 trial of this novel combination in NSCLC, and clinical results from an ongoing Phase 1b trial in patients with metastatic NSCLC, both naïve and refractory or resistance to anti-PD-(L)1 treatment, will be presented at ESMO Congress 2021.

Another novel combination of tislelizumab that BeiGene is investigating in lung cancer is with ociperlimab, a potent, Fc-intact investigational anti-TIGIT-antibody in Phase 3 clinical development. TIGIT is a co-inhibitory immune checkpoint receptor expressed on multiple immune cells and has recently emerged as a new therapeutic target that in collaboration with PD-1 has the potential to further suppress antitumor immune response. Tislelizumab’s broad combination portfolio in lung cancer also includes PI3K-delta inhibitor BGB-10188, anti-TIM-3 antibody BGB-A425, and chemotherapy.

Growing NSCLC Program Driven by Scientific Excellence and Clinical Insights

To address the prevalence of NSCLC worldwide and the clinical unmet need despite treatment progress in recent years, BeiGene is currently evaluating tislelizumab in a comprehensive NSCLC program of more than 10 clinical trials covering disease settings from early to late lines.

To gain key insights into how different patient characteristics can impact treatment outcomes, BeiGene’s immuno-oncology team reviews clinical results from NSCLC trials by geography, disease stage, smoking status, and using biomarkers.

Subgroup analyses on BeiGene’s RATIONALE 307 trial recently presented at the 2021 World Conference on Lung Cancer (WCLC) showed that tislelizumab in combination with chemotherapy provided consistent survival benefits in treatment-naïve patients with squamous NSCLC, regardless of PD-L1 expression, blood tumor mutation burden (TMB), tissue TMB, and disease stage (IIIB or IV).

At the ESMO Congress 2021, additional analyses on smokers vs. nonsmokers in the two Phase 3 clinical trials in first-line NSCLC, RATIONALE 304 and RATIONALE 307 will be reported.

In addition, the Company is exploring tislelizumab’s potential as an early treatment option, with an ongoing global Phase 3 trial RATIONALE 315 in neoadjuvant or adjuvant settings.

BeiGene’s ePoster Presentations at ESMO Congress 2021

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 team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. 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. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and 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 and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

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 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 BeiGene's plan for the advancement, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab and other drug candidates, 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 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.

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