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SEC Filings

8-K
BEIGENE, LTD. filed this Form 8-K on 01/07/2019
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Internally - Developed 6 GAZYVA ® combo (CD20) monotherapy PROGRAM (TARGET) DOSE EXPANSION PIVOTAL PH1b PH2* PH2** PH3 DOSE ESC. PH1a * Some indications will not require a non - pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. **Conf irmatory clinical trials post approval are required for accelerated approvals. ***REVLIMID ® approved as a combination therapy with dexamethasone. 1. Celgene has the right to develop and commercialize tislelizumab in s oli d tumors in the U.S., EU, Japan and the rest - of - world outside of Asia. 2 .Collaboration with Mirati Therapeutics, Inc; APAC study. 3. Collaboration with Zymeworks . monotherapy BeiGene Product Portfolio and Pipeline Three Marketed Products in China, Three Late - Stage Assets, and Six Early - Stage Clinical Assets zanubrutinib (BTK) tislelizumab (PD - 1) pamiparib (PARP) REVLIMID ® ABRAXANE ® VIDAZA ® avadomide sitravatinib Marketed Marketed Marketed Planned (in Ph2 ex - China by Celgene) COMMERCIAL RIGHTS Asia ex - Japan, AU, NZ 2 Global (heme malignancies) Asia ex - Japan (solid tumors) ¹ • R/R FL pamiparib combo (PARP) zanubrutinib combo (BTK) • Solid tumors • B - cell malignancies • R/R MM (marketed), NDMM (marketed), R/R NHL (Ph3) • Breast cancer • MDS, AML with 20 - 30% bone marrow blasts, CMMoL • NHL • Solid tumors • R/R MCL, R/R CLL/SLL (NDAs accepted) • R/R WM • WM, 1L CLL/SLL, R/R CLL/SLL • R/R MZL LEAD INDICATIONS ASSETS PROGRAMS (MECHANISMS) (CC - 122, CELMoD ) (multi - kinase inhibitor) China Global Global monotherapy • Solid tumors • 3L gBRCA + ovarian cancer • 2L platinum - sensitive ovarian cancer maintenance • 1L platinum - sensitive gastric cancer maintenance TMZ combo (Chemo) • Solid tumors RT/TMZ combo (RT/Chemo) • Glioblastoma Global lifirafenib (RAF Dimer) monotherapy • B - Raf - or K - RAS/N - RAS - mutated solid tumors • B - Raf - or K - RAS/N - RAS - mutated solid tumors Global monotherapy and tislelizumab combo (PD - 1) BGB - A333 (PD - L1) • Solid tumors Global China Global In - Licensed BGB - A425 (TIM - 3) monotherapy and tislelizumab combo (PD - 1) • Solid tumors Global (hypomethylating agent) (albumin - bound paclitaxel) ( IMiD ) China China China • R/R HL (NDA accepted) • 2L+ UC (pivotal Ph2) • 2L NSCLC, 1L HCC, 2L ESCC • 2L/3L HCC • R/R NK/T - cell lymphoma chemo combo (Chemo) • 1L Sq NSCLC, 1L Non - Sq NSCLC • 1L GC, 1L ESCC FILED ZW25 (bispecific HER2 antibody ) Asia ex - Japan, AU, NZ 3 • HER2+ gastric, breast and other cancers Planned (in Ph1b ex - China by Zymeworks )

 


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