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 its participation in the J.P. Morgan 39th Annual Healthcare Conference on January 14, 2021, at 5:20 p.m. ET. Investors can access a live webcast through BeiGene's website, with an archived replay available for 90 days post-event. As a global biotechnology company, BeiGene focuses on developing innovative medicines, particularly in oncology, with products like BRUKINSA and tislelizumab currently marketed. The company employs over 5,000 staff across multiple regions, committed to improving patient outcomes.
BeiGene announced the inclusion of three of its oncology drugs in China's updated National Reimbursement Drug List (NRDL): tislelizumab, BRUKINSA (zanubrutinib), and XGEVA (denosumab). This change, confirmed by the China National Healthcare Security Administration, aims to enhance patient access and reduce financial burdens on cancer patients in China. The company plans to collaborate with NHSA for further NRDL inclusion of expanded indications for these therapies. BeiGene will also hold a conference call on December 28 to discuss these developments.
BeiGene, Ltd. announced that the China National Medical Products Administration has approved BLINCYTO for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This marks the first approval of BLINCYTO in China and BeiGene's first product licensed from Amgen to receive approval. BLINCYTO, a bispecific immunotherapy, has shown superiority in overall survival compared to chemotherapy, reportedly doubling patient survival rates. The approval is based on a Phase 3 trial that demonstrated a 47.8% efficacy rate in Chinese subjects.
BeiGene presented new clinical data for its BTK inhibitor BRUKINSA (zanubrutinib) at the 62nd ASH Annual Meeting. Results from a Phase 2 trial showed BRUKINSA was effective in patients with relapsed/refractory B-cell malignancies who were intolerant to previous treatments with ibrutinib and/or acalabrutinib, demonstrating a safety profile that encourages further development. A pivotal Phase 2 trial in China for Waldenström's Macroglobulinemia also yielded promising results, with a major response rate nearing 70%. Priority reviews are underway for the supplemental new drug application in China.
BeiGene, Ltd. (NASDAQ: BGNE) announced significant clinical findings for its BTK inhibitor BRUKINSA® (zanubrutinib) at the 62nd ASH Annual Meeting. Initial results from the Phase 2 MAGNOLIA trial showed a 74.2% overall response rate in patients with relapsed/refractory marginal zone lymphoma. Additionally, the Phase 3 SEQUOIA trial's follow-up results indicated a 94.5% overall response rate and a 90.6% progression-free survival rate at 18 months in treatment-naïve patients with CLL/SLL with del(17p). These results support ongoing global regulatory submissions for BRUKINSA.
BeiGene, a biotechnology company, announced the pricing of a public offering of 1,511,546 American Depositary Shares (ADSs) at $225 per ADS, totaling approximately $340 million. The deal involves Selling Shareholders with a 30-day option for an additional 151,154 ADSs. Notably, BeiGene will not receive proceeds from this offering but will incur certain expenses. The transaction is expected to close on December 4, 2020, pending customary conditions. Goldman Sachs is the underwriter for this offering.
BeiGene, Ltd. (NASDAQ: BGNE) has launched an underwritten public offering of 1,511,546 American Depositary Shares (ADSs) by Selling Shareholders, aiming to enhance its market presence. Each ADS represents 13 ordinary shares, and the underwriter, Goldman Sachs & Co. LLC, has a 30-day option to purchase an additional 151,154 ADSs. BeiGene won't receive proceeds from this sale but will incur certain expenses. This offering is subject to market conditions, and the final terms will be disclosed in a prospectus supplement.
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is set to participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, where presentations will be available from November 23 to December 3, 2020. An archived replay will be accessible for 90 days on BeiGene’s investor webpages.
As a leading biotechnology firm, BeiGene is focused on innovative medicines, specifically in oncology, with products like BRUKINSA® and tislelizumab. The company's global team is dedicated to enhancing treatment options for patients worldwide.
BeiGene has received approval from the China National Medical Products Administration for XGEVA® (denosumab) to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors and multiple myeloma. The drug, developed by Amgen and licensed to BeiGene, is already approved in China for treating giant cell tumor of the bone. Clinical trials involving over 7,000 patients showed XGEVA significantly delayed SREs compared to the standard treatment zoledronic acid. This approval marks a crucial addition to BeiGene's oncology portfolio, enhancing treatment options for patients in China.
BeiGene announced that its RATIONALE 303 trial of tislelizumab met the primary endpoint of overall survival in patients with non-small cell lung cancer (NSCLC) who received prior platinum-based chemotherapy. Conducted globally, the trial included 805 patients, randomized to either tislelizumab or docetaxel. Tislelizumab exhibited a safety profile consistent with known risks, showing no new safety signals. This positive interim result marks a milestone in BeiGene's clinical development efforts, further supporting potential regulatory filings for tislelizumab.