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SEC Filings

8-K
BEIGENE, LTD. filed this Form 8-K on 11/13/2017
Entire Document
 
Exh. 99.2 - 3111 FPIs combined

Exhibit 99.2

 

图片 2           BeiGene,Ltd.


BeiGene Expands Global Pivotal Program for BTK Inhibitor BGB-3111

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Initiates global Phase 3 trial of BGB-3111 compared to bendamustine and rituximab (BR) in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) patients

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Initiates global pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA® (obinutuzumab) in relapsed or refractory follicular lymphoma (FL) patients

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Completes enrollment of pivotal Phase 2 trial in China in mantle cell lymphoma (MCL) patients

CAMBRIDGE, Mass., and BEIJING, China, November 13, 2017 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced the initiation of  two new global pivotal clinical trials of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, including a Phase 3 trial of BGB-3111 in previously untreated patients with CLL/SLL and a pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA® (obinutuzumab) in patients with relapsed or refractory FL. Along with a global Phase 3 trial comparing BGB-3111 to ibrutinib in Waldenström’s macroglobulinemia (WM), initiated in early 2017, BGB-3111 is now being evaluated in global pivotal trials in three distinct indications. Additionally, BGB-3111 is being evaluated in a broad pivotal clinical development program in China, including ongoing pivotal Phase 2 trials in MCL, CLL, and WM, which was initiated in August 2017. BeiGene also announced today that enrollment in the pivotal Phase 2 trial of BGB-3111 in China in MCL patients was completed in September 2017.

“The initiation of two additional pivotal trials expands our global registration-directed clinical development of BGB-3111 to additional indications, including patients with

 


 


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