BeiGene announced presentations from the Company's global clinical development programs in hematologic malignancies and solid tumors at the 2022 Annual Meeting of the American Society of Cancer Oncology (ASCO) being held on June 3-7, 2022. BeiGene presentation highlights: ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial.

RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer. 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, Great Britain, Canada, Australia, and additional international markets.

Currently, more than 40 additional regulatory submissions are in review around the world. Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body's immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to Fc?R on macrophages.

In pre-clinical studies, binding to Fc?R on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene's immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials.

More information on the clinical trial program for tislelizumab can be found at: https://www.beigene.com/en-us/science-and-product-portfolio/pipeline. Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab is currently in regulatory review in first line recurrent/metastatic nasopharyngeal cancer in China and as a potential treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy in the U.S. and in NSCLC and ESCC in Europe.

In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the U.S., Europe, and Japan.