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SEC Filings

8-K
BEIGENE, LTD. filed this Form 8-K on 01/07/2019
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R/R marginal zone lymphoma (MZL) Relapsed / Refractory (R/R) chronic lymphocytic leukemia / small lymphocytic leukemia (CLL/SLL) (NDA Accepted) 8 China zanubrutinib + GAZYVA ® (BTK + CD20) tislelizumab + zanubrutinib (PD - 1 + BTK) Worldwide Worldwide Worldwide PROGRAM (TARGET) COMMERCIAL RIGHTS DOSE EXPANSION PIVOTAL PH1b PH2 1 PH2 2 PH3 DOSE ESC. PH1a Global 1. Some indications will not require a non - pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. 2. Confirmatory clinical trials post approval are required for accelerated approvals. 3. as of October 15, 2018 zanubrutinib (BGB - 3111, BTK) Waldenstrom’s macroglobulinemia (WM): zanubrutinib vs. ibrutinib Treatment - naïve CLL/SLL: zanubrutinib vs. BR R/R CLL/SLL: zanubrutinib vs. ibrutinib R/R mantle cell lymphoma (MCL) (NDA accepted) R/R diffuse large B - cell lymphoma WM B - cell malignancies R/R follicular lymphoma: zanubrutinib + GAZYVA ® vs. GAZYVA ® B - cell malignancies Hematological tumors ▪ More than 1,500 patients 3 enrolled across zanubrutinib program, including combination trials Zanubrutinib Clinical Program Broad Clinical Development Plan FILED

 


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