Articles from BeiGene, Ltd.

TEVIMBRA Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).
By BeiGene, Ltd. · Via Business Wire · December 27, 2024
BeiGene to Change Nasdaq Ticker Symbol to “ONC” on January 2; Present at 43rd Annual J.P. Morgan Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced it will change its Nasdaq ticker symbol to “ONC” on January 2, 2025, reflecting its long-standing commitment to delivering innovative oncology medicines globally.
By BeiGene, Ltd. · Via Business Wire · December 23, 2024
BeiGene Announces Global Licensing Agreement for MAT2A Inhibitor
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it has entered into a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. (“CSPC”) for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors.
By BeiGene, Ltd. · Via Business Wire · December 12, 2024
BeiGene Advances Leadership in CLL at ASH 2024 with New Data From Its Hematology Franchise Including BRUKINSA® and Novel Pipeline Assets
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that plans to change its name to BeOne Medicines Ltd., today announced the presentation of new clinical data at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, underscoring its leadership in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) through continued clinical success with BRUKINSA® (zanubrutinib) and promising advancements in its pipeline assets.
By BeiGene, Ltd. · Via Business Wire · December 9, 2024
BeiGene and CLL Society Partner to Advance Test Before Treat™ Campaign, Promoting Biomarker Testing to Improve Patient Outcomes in CLL
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced its new partnership with CLL Society, the world’s leading authority for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) cancer patients. Together, they are advancing Test Before Treat™, an awareness campaign that aims to connect with healthcare providers (HCPs) and educate patients with CLL/SLL about the critical importance of biomarker testing before initial treatment and retesting at each subsequent treatment to help ensure each patient receives the most effective, personalized therapy. BeiGene and CLL Society will spotlight the campaign and partnership launch during the upcoming American Society of Hematology (ASH) 2024 Annual Meeting and Exposition.
By BeiGene, Ltd. · Via Business Wire · December 4, 2024
BeiGene to Host Investor Webcast Highlighting Key Data from ASH and the San Antonio Breast Cancer Symposium on December 16, 2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it will host an investor webcast on December 16, 2024 at 8:30 am EST. The Company’s R&D leadership team will provide an update on BeiGene’s innovative portfolio and pipeline, focusing on key presentations at the American Society of Hematology Meeting (ASH) and the San Antonio Breast Cancer Symposium.
By BeiGene, Ltd. · Via Business Wire · December 2, 2024
European Commission Approves BeiGene’s TEVIMBRA for First-Line Treatment of Advanced/Metastatic Esophageal Squamous Cell Carcinoma and Gastric or Gastroesophageal Junction Cancer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines, today announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
By BeiGene, Ltd. · Via Business Wire · November 27, 2024
BeiGene to Present at Upcoming Investor Conferences
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it will participate in fireside chats at two upcoming investor conferences:
By BeiGene, Ltd. · Via Business Wire · November 26, 2024
BeiGene Announces Settlement of Litigation Against Generic Filer of BRUKINSA
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company which intends to change its name to BeOne Medicines Ltd., today announced it has entered into a settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of BRUKINSA® (zanubrutinib) in the U.S.
By BeiGene, Ltd. · Via Business Wire · November 19, 2024
BeiGene Unveils Proposed Name Change to BeOne Medicines, Reaffirming Its Mission to Unite Global Community Against Cancer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced its intent to change the Company’s name to BeOne Medicines Ltd., confirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
By BeiGene, Ltd. · Via Business Wire · November 14, 2024
BeiGene Announces Third Quarter 2024 Financial Results and Corporate Updates
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the third quarter of 2024.
By BeiGene, Ltd. · Via Business Wire · November 12, 2024
BeiGene to Present at the Jefferies London Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will participate in the Jefferies London Healthcare Conference on November 20, 2024, with a fireside chat at 2:30 p.m. GMT.
By BeiGene, Ltd. · Via Business Wire · November 6, 2024
BeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data across a range of B-cell malignancies and assets, including best-in-class Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib), at the 66th ASH Annual Meeting and Exposition in San Diego, December 7-10. BeiGene has 21 abstracts accepted at ASH 2024, with four selected for oral presentation.
By BeiGene, Ltd. · Via Business Wire · November 5, 2024
BeiGene Mourns Death of Beloved Board Member Donald Glazer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, is saddened to share the news that Donald Glazer recently passed away. Don was a Board member and the chair of the nominating and corporate governance committee.
By BeiGene, Ltd. · Via Business Wire · October 28, 2024
BeiGene Receives Positive CHMP Opinions for TEVIMBRA® as a First-Line Treatment for Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer and Esophageal Squamous Cell Carcinoma
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended authorization for TEVIMBRA® (tislelizumab) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC).
By BeiGene, Ltd. · Via Business Wire · October 21, 2024
BeiGene Highlights Waldenström’s Macroglobulinemia Innovation at IWWM 2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research from studies evaluating BRUKINSA® (zanubrutinib), Bruton tyrosine kinase (BTK) chimeric degradation activation compound (CDAC) degrader BGB-16673 and B-cell lymphoma 2 (BCL2) inhibitor sonrotoclax in patients with Waldenström’s macroglobulinemia at the 12th International Workshop on Waldenström's Macroglobulinemia (IWWM) Oct. 17-19 in Prague, Czech Republic.
By BeiGene, Ltd. · Via Business Wire · October 16, 2024
BeiGene Provides Update on FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%.
By BeiGene, Ltd. · Via Business Wire · September 26, 2024
Global Oncology Innovator BeiGene Appoints Shalini Sharp to Board of Directors
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the appointment of Shalini Sharp to its Board of Directors and as a member of the Board’s Audit Committee, effective September 27, 2024.
By BeiGene, Ltd. · Via Business Wire · September 26, 2024
BeiGene Announces Updates to Commercial Leadership Team
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the appointment of Matt Shaulis as General Manager of North America, effective September 25.
By BeiGene, Ltd. · Via Business Wire · September 9, 2024
BeiGene to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will participate in the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024, with a fireside chat at 10 a.m. EDT.
By BeiGene, Ltd. · Via Business Wire · August 28, 2024
BeiGene’s BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLL
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), for adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including BTK inhibitor (BTKi) and B-cell lymphoma 2 (BCL2) inhibitor.
By BeiGene, Ltd. · Via Business Wire · August 26, 2024
BeiGene Opens Flagship U.S. Biologics Manufacturing and Clinical R&D Facility, Continues Global Expansion to Deliver Medicines to More Patients Around the World
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the opening of its flagship U.S. facility in Hopewell, N.J., at the Princeton West Innovation Campus, which houses state-of-the-art biologics manufacturing capabilities and a clinical research and development center that further bolster the Company’s differentiated model as an oncology innovator. BeiGene has more than 30 molecules at clinical or commercial stage, and the 42-acre facility provides flexibility to scale production of its innovative medicines today and in the future to meet the needs of patients with cancer.
By BeiGene, Ltd. · Via Business Wire · July 23, 2024
BeiGene Announces Appointment of Aaron Rosenberg as Chief Financial Officer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the appointment of Aaron Rosenberg as Chief Financial Officer, effective July 22. Mr. Rosenberg will succeed Julia Wang, who is departing to pursue external opportunities and will stay with the Company through August to support the transition.
By BeiGene, Ltd. · Via Business Wire · July 18, 2024
BeiGene to Present New Data from SEQUOIA Study Evaluating BRUKINSA® plus Venetoclax in High-Risk First-Line CLL/SLL at EHA2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib) today at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain in an oral session (Abstract S160). The presentation will feature data from arm D of SEQUOIA evaluating BRUKINSA in combination with venetoclax in treatment-naïve (TN) patients with high-risk chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation. The preliminary data demonstrate that in the 65 response-evaluable patients treated with the combination, the overall response rate (ORR) was 100%, and the rate of complete response (CR) plus CR with incomplete hematopoietic recovery (CRi) was 48%. The safety profile of the combination is consistent with that of the treatment components, and no new safety signals were seen.
By BeiGene, Ltd. · Via Business Wire · June 14, 2024
BeiGene to Present at the Goldman Sachs 45th Annual Global Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the Company will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 with a fireside chat at 1:20 pm EDT.
By BeiGene, Ltd. · Via Business Wire · June 4, 2024
BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of new analyses for BRUKINSA® (zanubrutinib) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024. The presentations highlight analyses of the efficacy and safety of BRUKINSA compared to other Bruton’s tyrosine kinase inhibitors (BTKis) used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
By BeiGene, Ltd. · Via Business Wire · May 24, 2024
BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data from its hematology portfolio and pipeline at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June 13-16, 2024. BeiGene has 28 abstracts accepted at EHA2024, with four scheduled for oral presentations.
By BeiGene, Ltd. · Via Business Wire · May 14, 2024
BeiGene Reports First Quarter 2024 Financial Results and Business Updates
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced results from the first quarter 2024 and business highlights.
By BeiGene, Ltd. · Via Business Wire · May 8, 2024
BeiGene Demonstrates Global Progress in 2023 Responsible Business & Sustainability Report
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.
By BeiGene, Ltd. · Via Business Wire · April 26, 2024
Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024.
By BeiGene, Ltd. · Via Business Wire · April 24, 2024
BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
By BeiGene, Ltd. · Via Business Wire · April 23, 2024
BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. TEVIMBRA will be available in the U.S. in the second half of 2024.
By BeiGene, Ltd. · Via Business Wire · March 14, 2024
BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma
BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy. The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S.
By BeiGene, Ltd. · Via Business Wire · March 7, 2024
BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego. BeiGene has nine abstracts scheduled for poster presentations at AACR.
By BeiGene, Ltd. · Via Business Wire · March 6, 2024
BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia
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.
By BeiGene, Ltd. · Via Business Wire · February 29, 2024
BeiGene to Present at Upcoming Investor Conferences
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Company will participate in fireside chats at two upcoming investor conferences:
By BeiGene, Ltd. · Via Business Wire · February 28, 2024
BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The FDA’s action date on the BLA is expected in December 2024.
By BeiGene, Ltd. · Via Business Wire · February 27, 2024
BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today reinforced its continued global expansion, rapid global and U.S. revenue growth, and innovative R&D strategy with the presentation of results from the fourth quarter and full year 2023 and business highlights.
By BeiGene, Ltd. · Via Business Wire · February 26, 2024
BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications:
By BeiGene, Ltd. · Via Business Wire · February 26, 2024
BeiGene Welcomes Experienced Life Sciences Executive Olivier Brandicourt to Board of Directors
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that Olivier Brandicourt, M.D. has been appointed to its Board of Directors. Dr. Brandicourt will join the audit committee of the Board.
By BeiGene, Ltd. · Via Business Wire · January 23, 2024
FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has approved a label update for BRUKINSA® (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
By BeiGene, Ltd. · Via Business Wire · December 22, 2023
BeiGene to Present at the 42nd Annual J.P. Morgan Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Company will participate in the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8th, 2024 with a presentation at 1:30 pm PT.
By BeiGene, Ltd. · Via Business Wire · December 21, 2023
BeiGene to Host ASH Investor Meeting in Person and via Webcast on December 10, 2023
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will host an Investor Event at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego and via webcast at 8:00 PM PST on December 10, 2023. This event will cover BeiGene’s R&D progress and broad hematology portfolio, with invited speakers presenting key data from the ASH 2023.
By BeiGene, Ltd. · Via Business Wire · November 29, 2023
BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data across a range of assets and blood cancers at the upcoming 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 9-12 in San Diego, California. BeiGene has 24 abstracts accepted at ASH, with three abstracts scheduled for oral presentations.
By BeiGene, Ltd. · Via Business Wire · November 28, 2023
BeiGene and Ensem Therapeutics Announce Partnership to Advance Differentiated CDK2 Inhibitor
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and Ensem Therapeutics, Inc. (ENSEM), a biotechnology company focusing on high-value and difficult-to-drug oncology targets, today announced an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor.
By BeiGene, Ltd. · Via Business Wire · November 21, 2023
BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma
BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has granted marketing authorization for BRUKINSA® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. This marks the fourth indication in the European Union (EU) for BRUKINSA, which is now approved to treat more patient populations in the EU than any other Bruton’s tyrosine kinase (BTK) inhibitor.
By BeiGene, Ltd. · Via Business Wire · November 17, 2023
BeiGene Continues Global Growth with Third Quarter 2023 Financial Results and Business Updates
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results from the third quarter of 2023 and business highlights.
By BeiGene, Ltd. · Via Business Wire · November 9, 2023
BeiGene to Present at the Jefferies London Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Company will participate in the Jefferies London Healthcare Conference on Wednesday, November 15th, 2023 with a fireside chat at 2:00 pm GMT.
By BeiGene, Ltd. · Via Business Wire · November 8, 2023
BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia
BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of eligible adult patients with:
By BeiGene, Ltd. · Via Business Wire · October 20, 2023
BeiGene Announces the Phase 3 RATIONALE 315 Trial Met Primary Endpoints of Major Pathological Response Rate and Event-Free Survival for Tislelizumab Plus Chemotherapy in Patients with Resectable Non-Small Cell Lung Cancer (NSCLC)
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Phase 3 RATIONALE 315 study met its dual primary endpoints of major pathological response (MPR) by Blinded Independent Pathology Review (BIPR) and event-free survival (EFS) by Blinded Independent Central Review (BICR), demonstrating statistically significant and clinically meaningful improvements in patients with resectable Stage II or IIIA NSCLC treated with tislelizumab in combination with chemotherapy before surgery and as a single agent after surgery versus neoadjuvant chemotherapy plus placebo followed by placebo after surgery. The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy. The MPR and pCR data will be featured as a late-breaking mini oral presentation on October 23 at 2:55 p.m. CEST at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract #LBA58).
By BeiGene, Ltd. · Via Business Wire · October 17, 2023
BeiGene Announces Late-Breaking Data at ESMO Showing Tislelizumab plus Chemotherapy Significantly Improved Overall Survival at Final Analysis in First-Line Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced results from the final analysis of the Phase 3 RATIONALE 305 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) in the intent-to-treat (ITT) population as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). No new safety signals were identified. Study results will be featured as a late-breaking oral presentation on October 21 at 5:25 p.m. CEST at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract #LBA80).
By BeiGene, Ltd. · Via Business Wire · October 17, 2023
BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has approved TEVIMBRA® (tislelizumab) as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. Additionally, the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
By BeiGene, Ltd. · Via Business Wire · September 19, 2023
BeiGene Strengthens Global Portfolio and Regains Full Rights from Novartis for Anti-PD-1 Antibody TEVIMBRA® (tislelizumab)
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA (tislelizumab).
By BeiGene, Ltd. · Via Business Wire · September 19, 2023
BeiGene Accelerates Global Momentum with Strong Second Quarter 2023 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results from the second quarter of 2023 and business highlights.
By BeiGene, Ltd. · Via Business Wire · August 2, 2023
BRUKINSA® Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
By BeiGene, Ltd. · Via Business Wire · May 30, 2023
BeiGene Reports First Quarter 2023 Financial Results and Corporate Developments
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results for the first quarter 2023, recent business highlights, and upcoming milestones.
By BeiGene, Ltd. · Via Business Wire · May 4, 2023
BeiGene and SpringWorks Present Clinical Data on Lifirafenib, in Combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), and SpringWorks Therapeutics, Inc. (NASDAQSWTX), today announced that they will present updated clinical data from the Phase 1b trial of BeiGene’s RAF dimer inhibitor, lifirafenib, in combination with SpringWorks’ MEK inhibitor, mirdametinib, in patients with advanced or refractory solid tumors with RAS mutations, RAF mutations and other MAPK pathway aberrations. The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
By BeiGene, Ltd. · Via Business Wire · April 17, 2023
BeiGene Reports Fourth Quarter and Full Year 2022 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results for the fourth quarter and full year 2022, recent business highlights, and upcoming milestones.
By BeiGene, Ltd. · Via Business Wire · February 27, 2023
BeiGene Reports Third Quarter 2022 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide, today reported financial results for the third quarter of 2022, recent business highlights, and anticipated upcoming milestones.
By BeiGene, Ltd. · Via Business Wire · November 9, 2022
BeiGene Reports Second Quarter 2022 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide, today reported financial results for the second quarter of 2022, recent business highlights, and anticipated upcoming milestones.
By BeiGene, Ltd. · Via Business Wire · August 4, 2022
BeiGene Strengthens European Presence With the Opening of Regional Office in Basel, Switzerland
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, yesterday announced the opening of a new regional office in Basel, Switzerland. BeiGene has built a European organization, including commercial and clinical teams, and this new location will serve as a hub for the company’s operations in the region.
By BeiGene, Ltd. · Via Business Wire · May 17, 2022
BeiGene Reports First Quarter 2022 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today reported financial results for the first quarter of 2022, recent business highlights, and anticipated upcoming milestones.
By BeiGene, Ltd. · Via Business Wire · May 5, 2022
BeiGene Introduces Global Environmental, Social, and Governance Strategy
BeiGene, Ltd. (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 introduced the Company’s global environmental, social, and governance (ESG) strategy.
By BeiGene, Ltd. · Via Business Wire · April 26, 2022
IRC Determines BRUKINSA® (Zanubrutinib) Demonstrates Superior Overall Response Rate Versus Ibrutinib in Final Response Analysis of ALPINE Trial in Chronic Lymphocytic Leukemia
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced results from the Phase 3 ALPINE trial showing BTK inhibitor BRUKINSA® (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
By BeiGene, Ltd. · Via Business Wire · April 11, 2022
BeiGene Reports Fourth Quarter and Full Year 2021 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today reported financial results for the fourth quarter and full year of 2021, recent business highlights, and anticipated upcoming milestones.
By BeiGene, Ltd. · Via Business Wire · February 25, 2022
BeiGene to Present at the Guggenheim Healthcare Talks - 2022 Oncology Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global science-driven biotechnology company, today announced that the Company will participate in the Guggenheim Healthcare Talks, 2022 Oncology Conference on Thursday, February 10, 2022 at 9:00 a.m. ET.
By BeiGene, Ltd. · Via Business Wire · February 8, 2022
BeiGene to Present at the J.P. Morgan 40th Annual Healthcare Conference
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global science-driven biotechnology company, today announced that the Company will participate in the J.P. Morgan 40th Annual Healthcare Conference on Tuesday, January 11, 2022 at 5:15 p.m. ET.
By BeiGene, Ltd. · Via Business Wire · January 6, 2022
BeiGene Expands Collaboration with Novartis to Develop and Commercialize BeiGene’s TIGIT Inhibitor and Market Five Novartis Oncology Medicines in China Broad Markets
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global science-driven biotechnology company, today announced an option, collaboration and license agreement with Novartis Pharma AG to develop, manufacture and commercialize BeiGene’s investigational TIGIT inhibitor ociperlimab in North America, Europe, and Japan. In addition, the parties entered into an agreement granting BeiGene rights to market, promote and detail five approved Novartis oncology products, TAFINLAR® (dabrafenib), MEKINIST® (trametinib), VOTRIENT® (pazopanib), AFINITOR® (everolimus), and ZYKADIA® (ceritinib), across designated regions of China referred to as “broad markets.”
By BeiGene, Ltd. · Via Business Wire · December 20, 2021
BeiGene Announces Closing of Its RMB22.2 Billion (US$3.5 Billion) Initial Public Offering on the STAR Market of the Shanghai Stock Exchange in China
BeiGene, Ltd. (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 that it has completed its previously announced initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE). The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) in Renminbi (RMB Shares). The RMB Shares began trading on the STAR Market under the stock code “688235” on December 15, 2021, China time, making BeiGene the first triple-listed biotechnology company on NASDAQ, the Hong Kong Stock Exchange (HKEx), and the STAR Market.
By BeiGene, Ltd. · Via Business Wire · December 14, 2021
BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) and EUSA Pharma (UK), Ltd. today announced that the China National Medical Products Administration (NMPA) has approved SYLVANT® (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). This disease is a rare, life-threatening, and debilitating condition of the lymph nodes and related tissues. Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.
By BeiGene, Ltd. · Via Business Wire · December 2, 2021
BeiGene Announces Pricing of its RMB22.2 billion (US$3.5 billion) Initial Public Offering on the STAR Market of the Shanghai Stock Exchange in China
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced the pricing of its previously announced initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE). The total number of shares being offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered. The shares offered in the STAR Offering will be issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) and listed and traded on the STAR Market in Renminbi (RMB Shares).
By BeiGene, Ltd. · Via Business Wire · November 30, 2021
BeiGene Launches Proposed Initial Public Offering on the STAR Market in China
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced the commencement of an initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE). The total number of shares being offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered. The shares offered in the STAR Offering (RMB Shares) will be issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) and listed and traded on the STAR Market in Renminbi. In addition, BeiGene expects to grant China International Capital Corporation Limited a 30-day overallotment option for up to 17,258,000 additional RMB Shares. The consummation of the STAR Offering is subject to, among other things, market conditions, and there can be no assurance as to whether or when the STAR Offering may be completed, or as to the actual size or terms of the STAR Offering.
By BeiGene, Ltd. · Via Business Wire · November 23, 2021
BeiGene Closes on Property for New U.S. Manufacturing and Clinical R&D Center
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative cancer medicines worldwide, announced today that it has purchased a 42-acre site at the Princeton West Innovation Campus in Hopewell, N.J. to house a new state-of-the-art manufacturing campus and clinical R&D center. As a key part of BeiGene’s continued growth, the company is investing in U.S. manufacturing to further expand and diversify its global supply chain and build new manufacturing capabilities for its deep pipeline of biologic and drug candidates.
By BeiGene, Ltd. · Via Business Wire · November 23, 2021
BeiGene Reports Third Quarter 2021 Financial Results
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today reported recent business highlights, anticipated upcoming milestones, and financial results for the third quarter and nine months ended September 30, 2021.
By BeiGene, Ltd. · Via Business Wire · November 4, 2021
BeiGene Announces Inclusion in FTSE Russell Indices
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, has announced its inclusion in several FTSE Russell indices, including: the FTSE Global Equity Index Large Cap; the FTSE All-World (LM); the FTSE All-Cap (LMS); and the FTSE Total-Cap (LMSµ). In addition, BeiGene has also been included in the FTSE Developed ESG Low Carbon Select Index, and the FTSE Asia ex Japan ESG Low Carbon Select Index, reflecting the company’s commitment to sustainability. The company’s inclusion on the FTSE indices became effective on Friday, September 17, 2021, after U.S. market close.
By BeiGene, Ltd. · Via Business Wire · September 20, 2021