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.

BEIJING, China and CAMBRIDGE, Mass., July  27, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China

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BEIJING, China and CAMBRIDGE, Mass., July  17, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China

CAMBRIDGE, Mass. and BEIJING, China, July  15, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the closing of a registered direct offering of 145,838,979 ordinary shares, par value $0.0001 per share (the “Ordinary Shares”), to certain existing investors.

BeiGene Announces Closing of Approximately $2.08 Billion Registered Direct Offering

Investors cheered another big investment in the Chinese biotech.

Why BeiGene Stock Jumped Today

BeiGene (BGNE) saw a big move last session, as its shares jumped nearly 9% on the day, amid huge volumes.

BeiGene (BGNE) in Focus: Stock Moves 8.7% Higher

BeiGene (NASDAQ: BGNE) shares are trading higher on Monday after Amgen announced a $421 million investment in the company.

Why BeiGene's Stock Is Trading Higher Today

CAMBRIDGE, Mass. and BEIJING, China, July  12, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the pricing of a registered direct offering of 145,838,979 ordinary shares, par value $0.0001 per share (the “Ordinary Shares”), to certain existing investors.

BeiGene Announces Pricing of Approximately $2.08 Billion Registered Direct Offering

BEIJING, China and CAMBRIDGE, Mass., July  01, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab for the treatment of patients with previously treated unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Patients with Previously Treated Unresectable Hepatocellular Carcinoma in China

CAMBRIDGE, Mass. and BEIJING, China, July  01, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the appointment of Angus Grant, Ph.D., as Chief Business Executive. In this role, Dr. Grant will oversee business development, alliance management, and help drive external innovation and investment to guide BeiGene’s global growth strategy. Dr. Grant will report to John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. 

BeiGene Announces Appointment of Angus Grant as Chief Business Executive

BEIJING, China and CAMBRIDGE, Mass., June  30, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it has begun commercializing XGEVA® (denosumab) in China for the treatment of giant cell tumor of bone (GCTB). This marks the first Amgen product that has been transitioned to BeiGene for commercialization in China since the commencement of the parties’ global strategic oncology collaboration in January 2020. Amgen gained approval from the China National Medical Products Administration (NMPA) for XGEVA in May 2019 for the treatment of adults and skeletally mature adolescents (defined by at least one mature long bone and with a body weight ≥ 45 kg) with GCTB that is unresectable or where surgical resection is likely to result in severe morbidity. In addition, a supplemental new drug application (sNDA) for XGEVA as a prevention for skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors has been accepted by the Center for Drug Evaluation (CDE) of the NMPA in April 2020 and is currently under review.

BeiGene Begins Commercializing XGEVA® (Denosumab) in China

BEIJING, China and CAMBRIDGE, Mass., June  19, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC).

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Non-Squamous Non-Small Cell Lung Cancer in China

CAMBRIDGE, Mass. and BEIJING, China, June  18, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that its marketing authorization application (MAA) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA).

BeiGene Announces European Medicines Agency Acceptance of its Marketing Authorization Application for BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Waldenström’s Macroglobulinemia

CAMBRIDGE, Mass. and BEIJING, China, June  12, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that data on its BTK inhibitor zanubrutinib in relapsed/refractory (R/R) marginal zone lymphoma (MZL) and other B-cell malignancies and its anti-PD-1 antibody tislelizumab in R/R NK/T-cell lymphomas were presented at the 25th European Hematology Association (EHA) Virtual Congress, taking place on June 11-14.

BeiGene Presents Clinical Data on Zanubrutinib and Tislelizumab at the 25th European Hematology Association (EHA) Virtual Congress

First approvals for BRUKINSA in China and its first indication for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma First approvals for BRUKINSA in China and its first indication for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

BeiGene Announces the Approval of BRUKINSA™ (Zanubrutinib) in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma

- Additional follow-up in Phase 3 ASPEN trial continued to show clinically meaningful safety and tolerability advantages for zanubrutinib compared to ibrutinib and demonstrated favorable CR/VGPR rate   - Three-year data from Phase 1/2 trial evaluating patients with WM receiving zanubrutinib treatment showed high overall response rate   - Company to host investor conference call and webcast on ASCO clinical updates on Friday, May 29 at 8:00 p.m. ET

BeiGene Presents Updated Head to Head Results from Phase 3 Trial of Zanubrutinib vs. Ibrutinib in Patients with Waldenström’s Macroglobulinemia at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program

– Collaboration to explore multiple solid tumor cancer indications –

Chi-Med and BeiGene Enter into Clinical Collaboration to Evaluate Combinations of Surufatinib and Fruquintinib with Tislelizumab

CAMBRIDGE, Mass. and BEIJING, China and PETACH TIKVA, Israel, May  21, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and Medison Pharma Ltd., a leading global commercial partner for biotech and pharma companies that operates in Israel, Canada, and Central and Eastern Europe, today announced an exclusive distribution agreement for Medison to commercialize BeiGene’s BTK inhibitor BRUKINSA™ (zanubrutinib) in Israel and the acceptance of a new drug application (NDA) in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

BeiGene and Medison Pharma Announce Exclusive Distribution Agreement and Acceptance of New Drug Application for BTK Inhibitor BRUKINSA™ (zanubrutinib) in Israel

BEIJING, China and CAMBRIDGE, Mass., April  20, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC).

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer in China

BEIJING, China, and CAMBRIDGE, Mass., April  13, 2020  (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC) met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis, as assessed by independent review committee (IRC). The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified.

BeiGene Announces that the Phase 3 Trial of Tislelizumab Combined with Chemotherapy in Patients with First-Line Non-Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis

Second approval of tislelizumab in China, first in solid tumor Second approval of tislelizumab in China, first in solid tumor

China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma

- NMPA has suspended the importation, sales and use of ABRAXANE in China supplied by Celgene Corporation, a Bristol Myers Squibb (BMS) company

BeiGene Announces Supply Update for ABRAXANE® in China

-- Phase 1 Study Initiated in Australia with IND Cleared to Expand Study to the U.S.--    -- Industry-Leading Scientific Advisory Board Formed to Support Advancement of BGB-3245 --

MapKure, BeiGene and SpringWorks Announce Initiation of Phase 1 Clinical Trial of BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors

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