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Beigene Ltd (BGNE.OQ)

BGNE.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Beigene Says FDA Accepted Co's New Drug Application For Zanubrutinib
Thursday, 22 Aug 2019 

Aug 22 (Reuters) - Beigene Ltd <6160.HK>::U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS ACCEPTED COMPANY'S NEW DRUG APPLICATION FOR ZANUBRUTINIB.  Full Article

BeiGene Regains Global Rights to Investigational Anti-PD-1 Antibody Tislelizumab
Monday, 17 Jun 2019 

June 17 (Reuters) - Beigene Ltd <6160.HK>::BEIGENE REGAINS FULL GLOBAL RIGHTS TO ITS INVESTIGATIONAL ANTI-PD-1 ANTIBODY TISLELIZUMAB.BEIGENE LTD - ENTERED INTO A MUTUAL AGREEMENT WITH CELGENE CORPORATION TO TERMINATE PARTIES' GLOBAL COLLABORATION FOR TISLELIZUMAB.BEIGENE LTD - IN CONNECTION WITH TERMINATION, CELGENE HAS AGREED TO PAY $150 MILLION TO BEIGENE.BEIGENE LTD - BEIGENE EXPECTS TISLELIZUMAB TO RECEIVE ITS FIRST REGULATORY APPROVAL LATER THIS YEAR..  Full Article

Beigene Announces Acceptance Of Supplemental Import Drug Application In China For Abraxane
Tuesday, 4 Jun 2019 

June 4 (Reuters) - Beigene Ltd <6160.HK>::BEIGENE ANNOUNCES ACCEPTANCE OF SUPPLEMENTAL IMPORT DRUG APPLICATION IN CHINA FOR ABRAXANE IN METASTATIC PANCREATIC CANCER.  Full Article

Beigene Receives U.S. FDA Breakthrough Therapy Designation For Zanubrutinib
Tuesday, 15 Jan 2019 

Jan 15 (Reuters) - Beigene Ltd <6160.HK>::RECEIVES U.S. FDA BREAKTHROUGH THERAPY DESIGNATION FOR ZANUBRUTINIB IN MANTLE CELL LYMPHOMA.  Full Article

Beigene Receives FDA Breakthrough Therapy Designation For Zanubrutinib In Mantle Cell Lymphoma
Tuesday, 15 Jan 2019 

Jan 14 (Reuters) - Beigene Ltd <6160.HK>::BEIGENE RECEIVES U.S. FDA BREAKTHROUGH THERAPY DESIGNATION FOR ZANUBRUTINIB IN MANTLE CELL LYMPHOMA.  Full Article

Beigene Presents Preliminary Clinical Trial Data In Patients With Solid Tumors
Monday, 22 Oct 2018 

Oct 22 (Reuters) - Beigene Ltd <6160.HK>::BEIGENE PRESENTS PRELIMINARY CLINICAL DATA ON PARP INHIBITOR PAMIPARIB IN COMBINATION WITH LOW-DOSE TEMOZOLOMIDE IN PATIENTS WITH SOLID TUMORS AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY (ESMO) 2018 CONGRESS.BEIGENE LTD - TWO PATIENTS EXPERIENCED AES RESULTING IN DISCONTINUATION OF PAMIPARIB AND TMZ, ONE CONSIDERED RELATED TO STUDY TREATMENT.BEIGENE LTD - PRELIMINARY RESULTS, SAFETY AND TOLERABILITY PROFILE, SUPPORT CONTINUED DEVELOPMENT OF THE COMBINATION.  Full Article

MEI Pharma And Beigene Announce Clinical Collaboration
Thursday, 11 Oct 2018 

Oct 11 (Reuters) - Beigene Ltd <6160.HK>::MEI PHARMA AND BEIGENE ANNOUNCE CLINICAL COLLABORATION TO EVALUATE ME-401 IN COMBINATION WITH ZANUBRUTINIB IN PATIENTS WITH B-CELL MALIGNANCIES.MEI PHARMA INC - STUDY COSTS WILL BE SHARED EQUALLY BY PARTIES, AND MEI WILL SUPPLY ME-401 AND BEIGENE WILL SUPPLY ZANUBRUTINIB.MEI PHARMA INC - UNDER TERMS OF CLINICAL COLLABORATION AGREEMENT, MEI WILL AMEND ITS ONGOING PHASE 1B TRIAL.MEI PHARMA INC - WILL RETAIN FULL COMMERCIAL RIGHTS FOR ME-401 & BEIGENE WILL RETAIN FULL COMMERCIAL RIGHTS FOR ZANUBRUTINIB.MEI PHARMA - AMENDMENT OF ONGOING PHASE 1B TRIAL TO INCLUDE EVALUATION OF ME-401 IN COMBINATION WITH ZANUBRUTINIB IN PATIENTS WITH B-CELL MALIGNANCIES.  Full Article

Beigene Announces Preliminary Results From The Phase 1 Clinical Trial Of Zanubrutinib
Saturday, 22 Sep 2018 

Sept 21 (Reuters) - Beigene Ltd 6160.HK::BEIGENE ANNOUNCES PRELIMINARY RESULTS FROM THE PHASE 1 CLINICAL TRIAL OF ZANUBRUTINIB IN CHINESE PATIENTS WITH B-CELL LYMPHOMA AT ANNUAL MEETING OF THE CHINESE SOCIETY OF CLINICAL ONCOLOGY.BEIGENE LTD - NEW DRUG APPLICATION FILING FOR ZANUBRUTINIB IN CHINA IS CURRENTLY UNDER REVIEW BY NATIONAL MEDICAL PRODUCTS ADMINISTRATION OF CHINA.BEIGENE -PRELIMINARY FINDINGS SUGGESTED THERE WAS NO SIGNIFICANT DIFFERENCE IN PHARMACOKINETIC PROFILE OF ZANUBRUTINIB BETWEEN CHINESE AND NON-CHINESE PATIENTS.BEIGENE LTD - NO DEATHS RELATED TO ADVERSE EVENTS WERE OBSERVED IN THE TRIAL.  Full Article

Beigene And Springworks Therapeutics Collaborate To Evaluate Targeted Combination Therapy In Advanced Solid Tumors
Thursday, 6 Sep 2018 

Sept 6 (Reuters) - Beigene Ltd <6160.HK>::BEIGENE AND SPRINGWORKS THERAPEUTICS ENTER INTO GLOBAL CLINICAL COLLABORATION TO EVALUATE TARGETED COMBINATION THERAPY IN ADVANCED SOLID TUMORS.BEIGENE LTD - BEIGENE'S RAF DIMER INHIBITOR LIFIRAFENIB (BGB-283) AND SPRINGWORKS THERAPEUTICS' MEK INHIBITOR PD-0325901 TO BE STUDIED IN COMBINATION.BEIGENE LTD - COMBINATION APPROACH WILL TARGET RAS MUTATIONS COMMON IN MANY CANCERS IN COLLABORATION.BEIGENE LTD - PHASE 1B CLINICAL STUDY EXPECTED TO COMMENCE IN Q1 OF 2019.BEIGENE LTD - PHASE 1B CLINICAL STUDY EXPECTED TO COMMENCE IN Q1 OF 2019.BEIGENE LTD - BEIGENE WILL BE RESPONSIBLE FOR ADMINISTERING PHASE 1B CLINICAL TRIAL.  Full Article

Beigene Announces Acceptance Of NDA For Tislelizumab In Hodgkin’s Lymphoma In China
Friday, 31 Aug 2018 

Aug 31 (Reuters) - Beigene Ltd <6160.HK>::BEIGENE ANNOUNCES ACCEPTANCE OF NEW DRUG APPLICATION FOR ANTI-PD-1 ANTIBODY TISLELIZUMAB IN HODGKIN’S LYMPHOMA IN CHINA.BEIGENE - NMPA ACCEPTED NDA FOR TISLELIZUMAB AS POTENTIAL TREATMENT FOR PATIENTS WITH RELAPSED/REFRACTORY CLASSICAL HODGKIN'S LYMPHOMA.  Full Article