BeiGene

BeiGene Ltd. is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. The company was founded by Xiao Dong Wang and John V. Oyler on October 28, 2010 and is headquartered in George Town, KY.

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BeiGene Ltd. Is a global oncology company, which engages in providing pharmaceutical products. Its medicines include BRUKINSA, TEVIMBRA, and PARTRUVIX. The company was founded by Xiao Dong Wang and John V. Oyler on October 28, 2010 and is headquartered in George Town, KY.

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The FDA has granted accelerated approval to BeiGene Ltd's (NASDAQ: BGNE) Brukinsa (zanubrutinib) for relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. The accelerated approval is based on the overall response rate (ORR).

BeiGene's Brukinsa Scores FDA Approval For Marginal Zone Lymphoma

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--U.S. FDA Grants BRUKINSA® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

U.S. FDA Grants BRUKINSA® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

The FDA accepts for review BeiGene's (BGNE) BLA for tislelizumab to treat patients with locally advanced/metastatic esophageal squamous cell carcinoma after prior systemic therapy.

BeiGene's (BGNE) BLA for Tislelizumab in ESCC Accepted by FDA

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--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 that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or me

BeiGene Announces U.S. FDA Acceptance of Biologics License Application for Tislelizumab in Esophageal Squamous Cell Carcinoma

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that clinical results and subgroup analyses from the Company's robust lung cancer program will be presented at the European Society for Medical Oncology (ESMO) Congress 2021. “We continue to make meaningful progress with our deep immuno-oncology portfolio, including our lung cancer program

BeiGene to Present Latest Findings in Robust Lung Cancer Portfolio at ESMO Congress 2021

The company won another FDA approval for blood cancer drug Brukinsa.

Why BeiGene Stock Is Soaring This Week

The FDA approves BeiGene's (BGNE) Brukinsa for the treatment of adult patients with Waldenstrom's macroglobulinemia. This marks the second approval for the drug in the United States.

BeiGene (BGNE) Gets FDA Nod for Brukinsa Label Expansion

The FDA has approved BeiGene Ltd (NASDAQ: BGNE) Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström's macroglobulinemia (WM). Brukinsa WM approval is the second therapy approved specifically for the treatment of this rare type of lymphoma.

BeiGene's Brukinsa Scores FDA Approval For Rare Blood Cancer Indication

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE--U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström's Macroglobulinemia

U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström's Macroglobulinemia

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today 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 anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Nasopharyngeal Cancer

BASEL, Switzerland--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström's macroglobulinaemia (WM). Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic. Swissmedic,

BeiGene Announces Acceptance by Swissmedic of Marketing Authorization Application for BRUKINSA® (Zanubrutinib) in Waldenström's Macroglobulinaemia

The China National Medical Products Administration (NMPA) granted conditional approval for BeiGene Ltd (NASDAQ: BGNE) - EUSA Pharma's (UK) Qarziba (dinutuximab beta) in high-risk neuroblastoma patients. The approval comes for patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation.

BeiGene's Pediatric Tumor Drug Scores Conditional Approval In China

CAMBRIDGE, Mass. & BEIJING & HEMEL HEMPSTEAD, England--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) and EUSA Pharma (UK), Ltd. today announced that the China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem

BeiGene and EUSA Pharma Announce China NMPA Approval of QARZIBA® (Dinutuximab Beta) for Patients with High-Risk Neuroblastoma

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--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 that it will host an investor conference call and webcast on Wednesday, August 25, 2021, at 9:30 a.m. ET to discuss the Company's early development pipeline and research. A live webcast of the conference call can be accessed

BeiGene to Host Investor Conference Call and Webcast to Discuss the Company's Early Development Pipeline and Research on August 25, 2021

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--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 second quarter and six months ended June 30, 2021. “We continued executing on our key strategic objectives during the second quarter and took steps to further position BeiGene to become highly impactf

BeiGene Reports Second Quarter 2021 Financial Results

HOPEWELL, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative cancer medicines worldwide, announced today its plans to build a new campus for R&D and manufacturing at the Princeton West Innovation Campus in Hopewell, NJ. BeiGene has entered into a purchase agreement to acquire an approximately 42-acre site with over one million square feet of developable real estate, to build

BeiGene Announces Plans to Build New Manufacturing and Clinical R&D Center at Princeton West Innovation Park in Hopewell, New Jersey

BeiGene Ltd (NASDAQ: BGNE) announced positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing Brukinsa (zanubrutinib) to bendamustine and rituximab (B+R). The trial included patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose tumor did not exhibit the deletion of chromosome 17p13.1 (del[17p]).

BeiGene's Brukinsa Prolongs Progression-Free Survival Compared To Chemo In Untreated Blood Cancer Patients

CAMBRIDGE, Mass. & BEIJING, China--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company, today announced positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing BRUKINSA® (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose tumor did not exhibit the deletion of chromosome 17p13.1 (del[17p]). With a

BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA® (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia

A regulatory filing gave a sneak peek at the company's second-quarter sales.

Why BeiGene Stock Soared Today

Health Canada has approved BeiGene Ltd (NASDAQ: BGNE) Brukinsa (zanubrutinib) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This is the second approval for Brukinsa in Canada, following its initial approval in March for adult patients with Waldenström's macroglobulinemia (WM).

BeiGene's Brukinsa Scores Second Approval In Canada, This Time For Mantle Cell Lymphoma

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--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 that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This is the second approval for BRUKINSA in Cana

BeiGene Announces Approval in Canada of BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Mantle Cell Lymphoma

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The China National Medical Products Administration (NMPA) has conditionally approved Kyprolis (carfilzomib) for relapsed or refractory (R/R) multiple myeloma. The approval covers Kyprolis in combination with dexamethasone for adult patients who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.

BeiGene-Amgen's Kyprolis Gets Approval In China For Pre-Treated Multiple Myeloma Patients

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene Announces the Approval in China of KYPROLIS® (Carfilzomib) for Injection for Adult Patients with Relapsed or Refractory Multiple Myeloma

BeiGene Announces the Approval in China of KYPROLIS® (Carfilzomib) for Injection for Adult Patients with Relapsed or Refractory Multiple Myeloma

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)---- $BGNE #BTKi--BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Esophageal Squamous Cell Carcinoma (ESCC)

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