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WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of four abstracts that highlights data from its immunology portfolio at the ACR Convergence 2024 taking place in Washington, D.C. from November 14–19, 2024. Sobi’s commitment to delivering innovative treatments for people living with immunological diseases is seen in global studies spanning multiple disorders: Results from two Phase 3 trials evaluating the effect on patient-reported outcomes in patients with chronic refractory gout treated with SEL-212.Initial data on the effect of anti-drug antibodies on serum uric acid (sUA) reduction and safety in response to treatment with SEL-212.DISSOLVE 1 Phase 3 study: Results of a post hoc analysis of sustained sUA reduction and safety of SEL-212 in patients with chronic refractory gout living in the United States.Results from a Phase 3 Study and a pooled analysis of two prospective trials evaluating efficacy and safety of emapalumab in patients with Macrophage Activation Syndrome in Still’s disease. Key Sobi data to be presented at ACR Convergence 2024 Chronic Refractory GoutSEL-212Improvements in Patient-Reported Outcomes After Treatment with SEL-212 in Adults with Refractory Gout: Results from Two Randomized Phase 3 TrialsSession: Patient Outcomes, Preferences, & Attitudes Poster ISaturday, November 16; 10:30 AM - 12:30 PMImpact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional TherapySafety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE StudiesSession: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster IIIMonday, November 18; 10:30 AM - 12:30 PM Macrophage Activation SyndromeEmapalumabEfficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective TrialsLate-Breaking AbstractsNovember 19; Session Time: 8:00 AM - 9:30 AM; Presentation Time: 9:00 AM - 9:15 AM All abstracts can be accessed via the official ACR Convergence website. ContactsFor details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media, click here. About SEL-212SEL-212 is being developed as a novel once-monthly combination medicine that integrates targeted immunomodulation with uricase-based therapy and is being investigated for the treatment of chronic refractory gout . SEL-212 consists of pegadricase, a proprietary pegylated uricase, co-administered with nanoencapsulated sirolimus. About Chronic Refractory GoutGout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic refractory gout (CRG), where patients are resistant to conventional medicines and symptoms are more persistent. CRG is a painful and debilitating condition in people with persistent raised serum uric acid (sUA) levels, which may result in several flares per year and the development of nodular masses of uric acid crystals known as tophi. About emapalumab-lzsgEmapalumab-lzsg is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, emapalumab-lzsg is indicated for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab-lzsg is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval in 2018 was based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).For the treatment of HLH, Emapalumab is indicated for administration through twice per week until hematopoietic stem cell transplantation (HSCT). The efficacy and safety of emapalumab are currently being evaluated. Emapalumab is currently under investigation (phase 3) in patients with MAS in Still’s disease or systemic lupus erythematosus (SLE) (EMERALD; NCT05001737). U.S. Indication for Gamifant® (emapalumab-lzsg)Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Important Safety InformationInfectionsBefore initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay. During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated. Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration. Increased Risk of Infection With Use of Live VaccinesDo not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied. Infusion-Related ReactionsInfusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion. Adverse ReactionsIn the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%). Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema. Please see the full Prescribing Information for Gamifant. About Sobi North AmericaAs the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/usa or at www.sobi.com. About Sobi®Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Brian Castellibrian.castelli@sobi.com

Reactivation of P-BCMA-101 CAR-T cells and a repeat stringent complete response (sCR) more than 3 years after original CAR-T therapy Demonstrates potential of stem cell memory T cells (TSCM), a key differentiator for Poseida's CAR-T programs SAN DIEGO, Sept. 4, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, highlighted new data from a case study of a patient with relapsed multiple myeloma treated in a clinical trial of P-BCMA-101, the Company's original investigational T stem cell memory (TSCM)-rich BCMA targeting autologous CAR-T cell therapy. The data were presented in an oral session at the Society of Hematologic Oncology (SOHO) Twelfth Annual Meeting in Houston. "This case study demonstrates the remarkable potential of T stem cell memory-based therapies, providing a strong anti-myeloma response with a long-term remission and notably CAR-T cell persistence," said Thomas G. Martin, M.D., Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and Director of Hematology, Blood and Marrow Transplantation and Cellular Therapy at UCSF, and co-leader of the Cancer Immunology & Immunotherapy Program at the UCSF Helen Diller Family Comprehensive Cancer Center. "Most notably, we believe this is the first time that a T-cell engager has been seen to reactivate a CAR-T therapy, and the evidence suggests that this reactivation drove a second wave of CAR-T cell proliferation that led to another complete response three years after the initial successful CAR-T treatment. This patient is now off all anti-myeloma treatments and living in remission for more than nine months following 1 week of TCE therapy, a truly amazing outcome." "These patient clinical data demonstrate the power of TSCM CAR-T cells, which are a core element of all our investigational next-generation, off-the-shelf allogeneic CAR-T cell therapies," said Syed Rizvi, M.D., Chief Medical Officer of Poseida Therapeutics. "P-BCMA-101 demonstrated durable persistence due to the high TSCM content in the final product. This long-term persistence and engraftment led to activation by the TCE several years after initial CAR-T therapy. The high TSCM content and durable persistence is a unique feature of all autologous and allogeneic Poseida CAR-T." Background Information and Oral Presentation Highlights Patients with relapsed/refractory multiple myeloma who receive BCMA-directed CAR-T therapy can achieve deep and durable remissions, but most patients relapse. Detection of CAR-positive cells wanes rapidly over the first six months, and significant re-expansion of CAR-T cells has not been demonstrated previously in the clinical setting. In this case study, a 57-year-old female patient with relapsed multiple myeloma received P-BCMA-101, an investigational TSCM-rich autologous CAR-T therapy. TSCM cells are a subset of T cells that have unique properties: They are long-lived, multi-potent and self-replicating and can engraft and create differentiated cells. Two months after receiving treatment, the patient achieved a partial response that deepened into a stringent complete response and remained in remission for nearly 2 years (22.5 months). More than three years after receiving P-BCMA-101, she relapsed and was treated with one cycle of talquetamab, a T-cell engaging bispecific antibody that targets CD3 and GPRC5D. Upon receiving talquetamab, the patient developed a brisk lymphocytosis. Evaluation of peripheral blood revealed high levels of P-BCMA-101 CAR-T cells. Thorough molecular analysis revealed that the lymphocytosis was benign and reactive. The patient achieved complete remission with slow resolution of lymphocytosis. The patient continues to be in sCR and off all therapy more than nine months after receiving the last and only full dose of the T-cell engaging therapy. Poseida's lead investigational allogeneic CAR-T program, P-BCMA-ALLO1, is currently being evaluated in patients with relapsed/refractory multiple myeloma. The Company will report new clinical data at the International Myeloma Society 21st Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024. Additional P-BCMA-ALLO1 clinical updates are planned for the second half of 2024, subject to coordination with Roche, which has a strategic collaboration with Poseida covering multiple investigational allogeneic CAR-T therapies targeting blood cancers, including P-BCMA-ALLO1. In November 2022, Poseida made the strategic decision to transition its cell therapy focus from an autologous to an allogeneic approach. The Company believes the future of cell therapy and its ability to offer new treatment options lies in an allogeneic approach in which T cells are derived from healthy donors rather than from the patients themselves. Poseida has applied learnings from its autologous programs to support the development of its allogeneic pipeline. About P-BCMA-ALLO1 P-BCMA-ALLO1 is an investigational allogeneic CAR-T therapy licensed to Roche that targets B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA. Phase 1 clinical data presented at ASH 2023 supports the Company's belief that TSCM-rich allogeneic CAR-Ts have the potential to offer an effective, safe and reliable treatment addressing unmet needs in multiple myeloma. The U.S. Food and Drug Administration granted Orphan Drug Designation to P-BCMA-ALLO1 for the treatment of multiple myeloma. Additional information about the Phase 1 study is available at (NCT04960579). About Poseida Therapeutics, Inc. Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for both solid tumors and hematologic cancers as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at and connect with Poseida on X and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy, safety and reliability profile of such product candidates; the quotes from Drs. Martin and Rizvi; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; and the other risks described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. SOURCE Poseida Therapeutics, Inc.

Matching adjusted indirect comparison addresses key questions and limitations associated with previously presented analysis and suggests efficacy advantage of BRUKINSA vs acalabrutinib BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced a new matching adjusted indirect comparison (MAIC) of the efficacy of BRUKINSA® (zanubrutinib) versus acalabrutinib in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) based on data from the Phase 3 ALPINE and Phase 3 ASCEND trials. The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival. These data will be presented during the 28th Annual International Congress on Hematologic Malignancies® in Miami from February 29 - March 3. “The CLL landscape is evolving rapidly, and this MAIC provides timely comparative effectiveness data for physicians, and reinforces zanubrutinib role as a foundational CLL treatment via a robust evaluation of the efficacy in the ASCEND and ALPINE studies; the presented analysis not only accounts for differences in key patient characteristics, but also clarifies the impact COVID-19 may have had on study outcomes,” said Mazyar Shadman, M.D. M.P.H, Study Author and Innovators Network Endowed Chair, Associate Professor of Hematology and Oncology, Lymphoid Malignancies and Immunotherapy, Fred Hutch Cancer Center and University of Washington. “Head-to-head randomized clinical trials are the gold standard when it comes to evaluating the potential impact of individual treatments for patients. MAICs are intended to be hypothesis-generating, provided they are conducted with appropriate rigor to minimize potential biases.” In this MAIC, individual patient-level data from ALPINE was matched against the aggregate data from ASCEND. An unanchored MAIC was used due to the lack of a common comparator arm between the ALPINE and ASCEND trials. Given the differences in the timing of the studies, with respect to the onset of the COVID-19 pandemic, the analysis adjusted for the impact of COVID-19 in the ALPINE study. In a previously published MAIC of BRUKINSA versus acalabrutinib,1 there were significant limitations that precluded a robust efficacy comparison, including the exclusion of data from the final analysis of ALPINE, lack of adjustment for the impact of COVID-19 on the outcomes, lack of adjustment for key differences in patient characteristics, the effective sample size, and the exclusion of complete response rate and overall survival from the analysis. “BeiGene is committed to continuing to further our understanding of the efficacy and safety of our therapies and their potential to help patients among other options,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “This MAIC addresses key questions raised in a previously published analysis, presenting a more holistic representation of the efficacy associated with BRUKINSA versus acalabrutinib in relapsed or refractory chronic lymphocytic leukemia setting.” BRUKINSA is the only Bruton’s tyrosine kinase (BTK) inhibitor to demonstrate progression-free survival superiority vs ibrutinib in R/R CLL, as observed in the ALPINE trial.2 Acalabrutinib has demonstrated improvement in progression-free survival vs rituximab plus idelalisib/bendamustine in R/R CLL in the ASCEND trial and has also demonstrated progression-free survival noninferiority vs ibrutinib R/R CLL patients with chromosome 17p or 11q deletions in the ELEVATE-RR trial.3,4 The MAIC suggests that investigator-assessed progression-free survival was improved for BRUKINSA versus acalabrutinib in both the unadjusted population (HR=0.77 [95%CI: 0.55-1.07]), as well as the base case adjusted population (HR=0.68 [95%CI: 0.46-0.99]). Additionally, the odds ratio (OR) for complete response favored BRUKINSA over acalabrutinib in the unadjusted (OR=2.88 [95%CI: 1.18-7.02]) and base case adjusted populations (OR=2.90; [95%CI: 1.13-7.43]). Results for the sensitivity analysis were consistent with the base case. The overall survival trend remained consistently in favor of BRUKINSA. For additional details of the analysis, please refer to the full poster presentation. While MAIC analyses can be hypotheses-generating, in the absence of head-to-head data, the safety of a drug may be best evaluated using all available evidence across indications. A recent independent Mayo Clinic meta-analysis of 61 trials involving 6,959 patients who received ibrutinib plus an anti-CD20 antibody, acalabrutinib, and BRUKINSA extensively analyzed the adverse event profiles of the two therapies across several indications and reported key differences in the safety profiles of the two treatments.5 BRUKINSA is approved in 70 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea and Switzerland in selected indications, and it is under development for additional indications globally. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions. About MAICs Match adjusted indirect comparisons are intended to be hypothesis generating, and do not establish superior efficacy or safety of one drug over another. Results should be viewed in the context of study limitations and available clinical data. About ALPINE ALPINE is a randomized, global, Phase 3 trial (NCT03734016) comparing BRUKINSA with ibrutinib in previously treated patients with R/R CLL or small lymphocytic lymphoma (SLL). In the trial, a total of 652 patients across Europe (60%), the United States (17%), China (14%), and New Zealand and Australia (9%) were randomized to receive BRUKINSA (160 mg orally twice daily) or ibrutinib (420 mg orally once daily) until disease progression, death, or unacceptable toxicity. The primary endpoint of overall response rate (ORR) was assessed by both investigator and independent review committee (IRC) using the modified 2008 iwCLL guidelines, with modification for treatment-related lymphocytosis for patients with CLL, and as per Lugano Classification for non-Hodgkin’s lymphoma for patients with SLL. Key secondary endpoints included PFS and the rate of atrial fibrillation or flutter; other secondary endpoints included duration of response, overall survival, and incidence of adverse events. There was a pre-specified hierarchical testing of non-inferiority followed by superiority for ORR as assessed by investigator and IRC. As ORR superiority was demonstrated, progression-free survival was tested for noninferiority and superiority under hierarchical testing. In an extended follow-up of the ALPINE study at a median follow-up of 39 months, BRUKINSA showed sustained PFS improvement versus ibrutinib (HR: 0.68 [95% CI, 0.53-0.86] P=0.0011) among R/R CLL/SLL patients, with durable PFS benefit observed across key subgroups, including patients with 17p deletion or TP53 mutation (HR: 0.52 [95% CI, 0.33-0.83] P=0.0047). PFS benefit was consistent across multiple sensitivity analyses, demonstrating that PFS advantage with BRUKINSA was primarily driven by efficacy, and not better tolerability. The overall safety and tolerability pro consistent with previous ALPINE analyses, including persistently lower rates of cardiovascular events reported with BRUKINSA. The most commonly reported treatment emergent adverse events (≥20%) with BRUKINSA were COVID-19-related infection, neutropenia, hypertension, and upper respiratory tract infection.6 About BRUKINSA® (zanubrutinib) BRUKINSA is a small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia or small lymphocytic lymphoma Waldenström’s macroglobulinemia Mantle cell lymphoma (MCL) who have received at least one prior therapy Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen The MCL and MZL indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%) and anemia (7%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g. palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions In this pooled safety population, the most common adverse reactions, including laboratory abnormalities, in ≥30% of patients who received BRUKINSA (N=1550) included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information and U.S. Patient Information. About BeiGene BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter). 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 potential of BeiGene’s therapies to help patients; the efficacy and safety of BRUKINSA versus acalabrutinib in patients with R/R CLL; BeiGene’s advancement, anticipated clinical development, regulatory submissions and commercialization of zanubrutinib, particularly as a treatment for R/R FL; and BeiGene’s plans, commitments, aspirations, and goals under the heading “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, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, 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. To access BeiGene media resources, please visit our News & Media site. 1 Kittai AS, et al. A matching-adjusted indirect comparison of acalabrutinib versus zanubrutinib in relapsed or refractory chronic lymphocytic leukemia. Am J Hematol. 2023 Dec;98(12):E387-E390. doi: 10.1002/ajh.27110. Epub 2023 Oct 9. PMID: 37811799. 2 Brown JR, et al. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2023 Jan 26;388(4):319-332. doi: 10.1056/NEJMoa2211582. Epub 2022 Dec 13. PMID: 36511784. 3 Ghia P, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27. PMID: 32459600. 4 Sharman JP, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020 Apr 18;395(10232):1278-1291. doi: 10.1016/S0140-6736(20)30262-2. Erratum in: Lancet. 2020 May 30;395(10238):1694. PMID: 32305093; PMCID: PMC8151619. 5 Hwang S, et al. P632: COMPARISON OF TREATMENT-EMERGENT ADVERSE EVENTS OF ACALABRUTINIB AND ZANUBRUTINIB IN CLINICAL TRIALS IN B-CELL MALIGNANCIES: A SYSTEMATIC REVIEW AND META-ANALYSIS. Hemasphere. 2023 Aug 8;7(Suppl ):e47546cf. doi: 10.1097/01.HS9.0000969432.47546.cf. PMCID: PMC10428881. 6 J. R. Brown, et. Al. Extended Follow-up of ALPINE Randomized Phase 3 Study Confirms Sustained Superior Progression-Free Survival of Zanubrutinib Versus Ibrutinib for Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (R/R CLL/SLL). Blood 2023; 142 (Supplement 1): 202. doi: .