Welcome to our dedicated page for Beigene news (Ticker: BGNE), a resource for investors and traders seeking the latest updates and insights on Beigene stock.
News about BeiGene, Ltd. (BGNE) centers on its role as a global oncology company advancing cancer medicines such as TEVIMBRA (tislelizumab) and BRUKINSA (zanubrutinib), along with a broad pipeline of solid tumor and hematology assets. The company’s announcements frequently cover regulatory milestones, clinical trial readouts, licensing deals and strategic updates tied to its oncology focus.
Recent news highlights include positive regulatory developments for TEVIMBRA, such as a positive opinion from the Committee for Medicinal Products for Human Use for first-line treatment of extensive-stage small cell lung cancer in combination with chemotherapy, European Commission approvals in first-line esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, and U.S. Food and Drug Administration approval for first-line treatment of certain HER2-negative gastric and gastroesophageal junction cancers. These stories typically detail Phase 3 trial results, overall survival outcomes and safety profiles.
BeiGene’s news flow also features updates from major scientific meetings, including new data from the SEQUOIA study of BRUKINSA in chronic lymphocytic leukemia/small lymphocytic lymphoma, early-phase results for sonrotoclax and BGB‑16673 in B‑cell malignancies, and broader pipeline presentations at forums such as the American Society of Hematology Annual Meeting. Additional items include a global licensing agreement for the MAT2A inhibitor SYH2039 for MTAP-deleted solid tumors and partnerships like the Test Before Treat campaign with CLL Society to promote biomarker testing in CLL/SLL.
Investors and followers of BGNE can use this news page to track regulatory decisions, clinical data releases, business development agreements, investor conference appearances and corporate identity plans, including BeiGene’s stated intent to change its name to BeOne Medicines Ltd. and its Nasdaq ticker symbol to ONC.
BeiGene, Ltd. (NASDAQ: BGNE) announced that the Center for Drug Evaluation of China's NMPA accepted a supplemental new drug application for tislelizumab in combination with chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC). This marks the second sNDA for tislelizumab in this indication. Clinical results supporting the application came from a Phase 3 trial, which showed a statistically significant improvement in progression-free survival. The drug has already secured regulatory approval for other cancer indications in China.
BeiGene, Ltd. (BGNE) announced that the European Medicines Agency has validated its marketing authorization application for BRUKINSA® (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) in patients with prior therapy or as a first-line treatment for those unsuited for chemo-immunotherapy. This marks BeiGene's first submission for WM, highlighting BRUKINSA's efficacy and safety compared to ibrutinib in the ASPEN trial. BRUKINSA has received approvals in the U.S. and China for different indications, and the company aims to expand its global development efforts.
BeiGene, Ltd. (BGNE) announced positive clinical data for its BTK inhibitor zanubrutinib and anti-PD-1 antibody tislelizumab at the 25th European Hematology Association (EHA) Virtual Congress. Zanubrutinib showed an overall response rate (ORR) of 80% in relapsed/refractory marginal zone lymphoma (MZL), with a complete response rate of 15%. The drug was well tolerated with main adverse events being grade 1 or 2. Tislelizumab presented an ORR of 31.8% in extranodal NK/T-cell lymphoma. The encouraging results provide a foundation for further trials and potential registrations.
BeiGene, Ltd. (BGNE) announced that its BTK inhibitor, BRUKINSA™ (zanubrutinib), received approval from the China NMPA for chronic lymphocytic leukemia and mantle cell lymphoma, following priority review. This follows the U.S. accelerated approval in November 2019 for MCL. The approval is based on clinical trials showing significant efficacy, with an overall response rate of 62.6% for CLL/SLL and 83.7% for MCL. The drug's safety profile includes notable adverse reactions, primarily neutropenia and pneumonia. The company aims to launch BRUKINSA as a leading treatment option for these conditions in China.
BeiGene, a biotechnology company, will host an investor conference call on May 29, 2020, at 8:00 p.m. ET to discuss clinical study results from the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. This event will be accessible via a live webcast on BeiGene's investor website, with a replay available for 90 days. BeiGene is focused on developing innovative cancer treatments and currently markets two oncology products: BRUKINSA™ and tislelizumab, with additional oncology products planned for the Chinese market.
BeiGene has entered into an exclusive distribution agreement with Medison Pharma for the commercialization of BRUKINSA™ (zanubrutinib) in Israel. This partnership marks BeiGene's first distribution agreement outside the U.S. and China and follows the acceptance of a New Drug Application (NDA) for BRUKINSA to treat mantle cell lymphoma (MCL). BRUKINSA has FDA accelerated approval for MCL in adults and is currently in pivotal trials for other indications. The collaboration aims to enhance patient access to this innovative therapy.
BeiGene, a biotechnology firm, will present at the Bernstein 36th Annual Strategic Decisions Conference on May 27, 2020, at 8:00 a.m. ET. The event will be accessible via a live webcast on BeiGene's investor website, with an archived replay available for 90 days. Founded with the aim of improving cancer treatment outcomes, BeiGene offers innovative drugs including the BTK inhibitor BRUKINSA and anti-PD-1 antibody tislelizumab. With over 3,800 employees across several regions, BeiGene remains committed to advancing cancer therapeutics.
BeiGene, a commercial-stage biotechnology company, announced the presentation of clinical and preclinical data at the 2020 AACR Virtual Annual Meeting II from June 22-24. The highlights include:
- Preliminary safety and efficacy data of BGB-A333 (anti-PD-L1) in advanced solid tumors.
- Data on BGB-10188 (PI3Kδ inhibitor) demonstrating improved safety and anti-tumor activities.
- Preclinical results for BGB-11417 (Bcl-2 inhibitor) showing antitumor potential in hematological models.
- RAF dimer inhibitor lifirafenib's ability to enhance MEK inhibitor activity in RAS mutant tumors.
Summary not available.