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 has announced plans to establish a new R&D and manufacturing campus at the Princeton West Innovation Campus in Hopewell, NJ. The company has entered a purchase agreement for a 42-acre site, aiming to develop over one million square feet for biologic pharmaceutical manufacturing and clinical R&D. This facility is expected to enhance BeiGene's supply chain capabilities and create hundreds of jobs in the region. Construction completion is anticipated in mid-2023, with interim leasing of nearby space to commence hiring immediately.
BeiGene announced positive topline results from the interim analysis of the Phase 3 SEQUOIA trial for BRUKINSA (zanubrutinib) in treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). With a median follow-up of 25.8 months, BRUKINSA significantly improved progression-free survival (PFS) compared to bendamustine and rituximab (B+R). The trial showed strong outcomes consistent with BRUKINSA's safety profile. BeiGene plans to consult with regulatory authorities regarding next steps and aims to present data at major medical conferences.
BeiGene, Ltd. (NASDAQ: BGNE) announced that Health Canada has approved BRUKINSA (zanubrutinib) for treating mantle cell lymphoma (MCL) in adults with at least one prior therapy. This marks the second approval for BRUKINSA in Canada. The therapy showed an overall response rate of 84% in clinical trials. Approximately 13.6% of patients discontinued treatment due to adverse events, with pneumonia being the most common. The drug offers a new option for patients with MCL, which often has a poor prognosis and is typically diagnosed at a late stage.
BeiGene, Ltd. (NASDAQ: BGNE) has received conditional approval from the China NMPA for KYPROLIS® (carfilzomib), in combination with dexamethasone, to treat adult patients with relapsed or refractory multiple myeloma after at least two prior therapies, including a proteasome inhibitor. This marks the first approval of KYPROLIS in China, following positive results from a Phase 3 trial. The overall response rate was 35.8% and median progression-free survival was 5.6 months. BeiGene plans to enhance treatment options for patients in China with this new addition to their portfolio of cancer therapies.
BeiGene has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for tislelizumab, an anti-PD1 antibody, for treating locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after first-line chemotherapy failure. Tislelizumab has shown improved efficacy over chemotherapy in a Phase 3 trial involving 512 patients across multiple regions. This sBLA represents the eighth marketing application for tislelizumab, which has already received five approvals in China.
BeiGene announced that the China National Medical Products Administration (NMPA) has granted approval for its anti-PD-1 antibody tislelizumab for first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) and conditional approval for hepatocellular carcinoma (HCC). This brings tislelizumab's total indications in China to five, enhancing its role in treating major cancer types. Based on positive results from recent clinical trials, BeiGene aims to increase access to these therapies in China and globally.
BeiGene has announced that its drug BRUKINSA (zanubrutinib) has received conditional approval from the China National Medical Products Administration for treating adult patients with Waldenström’s macroglobulinemia (WM) who have undergone at least one prior therapy. This marks the third approval in China for BRUKINSA, which was designed to provide cardiovascular safety advantages and effective responses in treating B-cell malignancies. The approval follows a pivotal Phase 2 trial showing a major response rate of 72.1% in WM patients.
BeiGene has initiated the global Phase 3 AdvanTIG-302 trial for its investigational anti-TIGIT antibody, ociperlimab (BGB-A1217), in combination with tislelizumab, targeting first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial aims to enroll approximately 605 patients whose tumors exhibit high PD-L1 expression. Key endpoints include progression-free survival and overall survival. This marks a significant milestone as ociperlimab enters pivotal clinical development, possibly offering a chemotherapy-free treatment alternative for NSCLC patients.
BeiGene announced long-term follow-up results for pivotal trials of its therapies at the 26th EHA Virtual Congress. Tislelizumab exhibited a 87.1% overall response rate and 67.1% complete response rate in R/R classical Hodgkin's lymphoma after 34 months, with a median progression-free survival of 31.5 months. BRUKINSA demonstrated an 83.7% overall response rate in R/R mantle cell lymphoma, with a median progression-free survival of 33 months over 35 months of follow-up, and continued efficacy in R/R chronic lymphocytic leukemia. All therapies maintained tolerable safety profiles.
BeiGene presented positive interim results from the Phase 3 ALPINE trial for its BTK inhibitor, BRUKINSA, at EHA2021. The trial showed superiority in the overall response rate (ORR) of 78.3% compared to 62.5% for ibrutinib (p=0.0006). Additionally, BRUKINSA had a significantly lower rate of atrial fibrillation (2.5% vs. 10.1%, p=0.0014) and better progression-free survival (PFS) rates (94.9% vs. 84.0%). The positive data reinforces BRUKINSA's safety and efficacy, offering significant benefits for patients with chronic lymphocytic leukemia.