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 a collaboration with Nanjing Leads Biolabs, granting BeiGene global rights to research and commercialize LBL-007, an investigational antibody targeting the LAG-3 pathway, outside of China. The deal includes a $30 million upfront payment and potential total payments up to $742 million, along with tiered royalties on sales. This partnership aims to enhance BeiGene's immuno-oncology portfolio, particularly in combination with its anti-PD-1 inhibitor, tislelizumab. LBL-007 is currently in Phase 1b/2 clinical trials in China.
BeiGene announced promising results from the interim analysis of the Phase 3 SEQUOIA trial for BRUKINSA in treatment-naïve chronic lymphocytic leukemia (CLL), showing superior progression-free survival (PFS) compared to bendamustine plus rituximab. The 24-month PFS rate for BRUKINSA was 85.5%, significantly higher than 69.5% for the control group. Consistent safety results were noted, with lower rates of adverse events like atrial fibrillation. Preliminary data for BRUKINSA combined with venetoclax in high-risk CLL patients also showed high efficacy and safety.
BeiGene presented new safety and efficacy data for BRUKINSA (zanubrutinib) at the 63rd ASH Annual Meeting. Results from a Phase 2 trial showed that 93.8% of patients maintained disease control, while 64.1% improved their response. Treatment was well-tolerated, with 59.6% of prior ibrutinib users and 70.0% of acalabrutinib users not experiencing recurrence of intolerable adverse events. BRUKINSA's design aims to optimize kinase selectivity, thus reducing off-target effects. These findings reinforce BRUKINSA's potential for B-cell malignancies patients intolerant to other BTK inhibitors.
BeiGene announced results from the RATIONALE 309 trial, where its drug tislelizumab significantly improved progression-free survival (PFS) in patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC) compared to placebo and chemotherapy. The median PFS was 9.2 months for the drug combination versus 7.4 months for placebo, demonstrating a notable survival benefit across subgroups. The safety profile was consistent with known risks, and a supplemental biologics license application is under review in China for this indication.
BeiGene (NASDAQ:BGNE) has announced the addition of three of its innovative oncology medicines to China's National Reimbursement Drug List (NRDL), effective January 1, 2022. The newly included medicines are anti-PD-1 antibody tislelizumab in three new indications, the BTK inhibitor BRUKINSA in one new indication, and the PARP inhibitor pamiparib for recurrent advanced ovarian cancer. This move aims to enhance patient access to effective cancer treatments while reducing financial burdens on families.
BeiGene, Ltd. (NASDAQ: BGNE) and EUSA Pharma have announced NMPA approval for SYLVANT® (siltuximab) in treating adult patients with idiopathic multicentric Castleman disease (iMCD) in China. This approval highlights the companies' collaboration and provides a vital new treatment option for patients suffering from this rare, debilitating disease. The approval is supported by a Phase 2 trial demonstrating significant efficacy with a durable response rate of 34% versus 0% for placebo. SYLVANT® has already been approved in multiple regions, and BeiGene plans to launch it in 2022.
BeiGene (NASDAQ: BGNE) announced that results from the RATIONALE 309 trial evaluating tislelizumab with chemotherapy in nasopharyngeal cancer will be presented at the ESMO IO Congress from December 8-11, 2021. This interim analysis supports a regulatory submission in China for recurrent or metastatic nasopharyngeal cancer. Additionally, data from trials involving tislelizumab combined with the kinase inhibitor sitravatinib in melanoma and ovarian cancer will be shared, highlighting the company's commitment to developing effective immunotherapies and addressing unmet medical needs globally.
BeiGene, Ltd. announced the pricing of its initial public offering (STAR Offering) on the STAR Market of the Shanghai Stock Exchange, offering 115,055,260 ordinary shares, representing 8.62% of its outstanding shares. The shares are priced at RMB192.60 each, yielding gross proceeds of approximately RMB22.2 billion (US$3.5 billion). The funds will support research, development, and expansion in China. The shares are expected to trade on December 15, 2021. An over-allotment option for 17,258,000 additional shares could increase the offering to 132,313,260 shares.
BeiGene announced the European Commission's approval of BRUKINSA (zanubrutinib) for treating Waldenström’s macroglobulinemia (WM) patients who have undergone prior therapy or are unsuitable for chemo-immunotherapy. This approval spans all EU member states, Iceland, and Norway. The decision is based on the Phase 3 ASPEN trial, showing BRUKINSA's safety advantages over ibrutinib despite not meeting the primary endpoint for statistical superiority. BeiGene aims to expedite access to this therapy across Europe.
BeiGene, Ltd. announced its initial public offering (IPO) on the STAR Market of the Shanghai Stock Exchange, offering 115,055,260 ordinary shares, representing 8.62% of its total shares as of October 31, 2021. The STAR Offering will be conducted for investors in the People's Republic of China (PRC) with additional options for 17,258,000 shares. Proceeds will fund R&D, the construction of centers in China, and sales expansion. The offering is subject to market conditions and regulatory approvals and will not involve the U.S. market.