Print Page     Close Window     

SEC Filings

8-K
BEIGENE, LTD. filed this Form 8-K on 01/07/2019
Entire Document
 

 

Capture significant global market share by demonstrating differentiation Capture large China opportunity with a broad development program WM, CLL, MCL (China), FL Lung, liver, gastric, and esophageal cancers, classical Hodgkin’s lymphoma (China), urothelial cancer (China) ▪ NDAs for R/R MCL and R/R CLL/SLL accepted by NMPA ▪ Priority review status granted to NDA in R/R MCL ▪ Fast track designated by FDA ▪ NDA for cHL in China accepted by NMPA ▪ Priority review status granted to NDA 86 - patient R/R MCL 1 ▪ 84% ORR ▪ 59% CR (8.3 mo f/u) 70 - patient China pivotal Ph2 R/R cHL 4 ▪ 86% ORR ▪ 61% CR (7.85mo f/u) ▪ Establish a global hematology commercial team ▪ Leverage growing commercial capabilities in China ▪ 24,000L biologics manufacturing facility under construction ▪ 2017 Global: $3.2 Bn ▪ 2025E Global: $13.8 Bn ▪ 2025E China: $1. 3 Bn ▪ 2017 Global ^ : $10.1 Bn ▪ 2025E Global^: $57.4 Bn ▪ 2025E China^: $12.1 Bn zanubrutinib Potentially Best - in - Class BTK Inhibitor tislelizumab PD - 1 Inhibitor Targeting Asia - Prevalent Tumors STRATEGY KEY TARGET INDICATIONS FILING PROGRESS COMMERCIAL CLASS REVENUE & FORECAST* * 7 Two Late - Stage Assets Represent Significant Commercial Opportunities 1. ASH 2018 Song et al.,; 2. IWWM 2018 Tam et al.,3. Pivotal trial, BeiGene press release 10/24/18; 4. ASH 2018 Song et al.; * All data are from independent review committee (IRC) assessment. Median follow up time. * *Frost&Sullivan analysis; RMB:USD conversion: 6.5:1. ^For PD - 1 & PD - L1 class PRELIMINARY FILING DATA IN CHINA * 91 - patient R/R CLL/SLL 3 ▪ 80% ORR ▪ 2% CR (9.1mo f/u) 73 - patient WM 2 ▪ 92% ORR, 82% MRR ▪ 41% VGPR (22.5m f/u)

 


© 2016 BeiGene. All Rights Reserved.