BeiGene Receives Approval to Initiate Clinical Trials in China With BGB-283 for Solid Tumor Cancers

BEIJING, Aug. 3, 2015 (GLOBE NEWSWIRE) -- BeiGene, Ltd., an innovative oncology company focusing on developing targeted and immuno-oncology therapeutics, today announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct Phase I clinical studies of BGB-283, a novel RAF dimer inhibitor for the treatment of solid tumors that harbor B-RAF mutations or other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.

"We are delighted to receive CTA approval in China from the CFDA to start BGB-283 clinical trials in China," said John V. Oyler, CEO of BeiGene. "Gaining trial approval in China is historically a lengthy, stringent process with high pharmaceutical standards that must be met to start human clinical trials. However, thanks to the efforts of our experienced team and support from China's Twelfth Five-Year Plan National Key Innovation Program – which is focused on national priorities including the development of highly innovative drugs such as BGB-283 - we have been able to progress this promising anticancer agent relatively quickly through the initial stages of development. This is an important step for our company as we move forward with our goal of developing best-in-class targeted and immuno-oncology therapeutics for cancer patients globally."

The clinical trials in China will investigate BGB-283 in patients with B-RAF mutations in a range of tumors where no other effective targeted therapies are currently available in China. Additionally, BGB-283 will be investigated in patients with K-RAS/N-RAS mutated cancers.

Ongoing clinical trials of BGB-283 in other countries have demonstrated a good safety profile, along with promising early anti-tumor activities.

About BGB-283

First generation B-RAF inhibitors including vemurafenib and dabrafenib selectively target mutant B-RAFV600E and have exhibited significant clinical activities in melanoma patients with the B-RAFV600E mutation. They are approved for the treatment of patients with B-RAFV600E metastatic melanoma. However, first generation B-RAF inhibitors have limited clinical activity outside of melanoma with B-RAFV600E mutation (1-4) and the patients developed resistance to the first generation drug relatively quickly. BGB-283 is a second-generation RAF inhibitor with unique RAF dimer and EGFR inhibiting activity. BGB-283 shows promising antitumor activities in preclinical models and in patients for not only cancers with B-RAFV600E mutation but also non-V600E B-RAF mutation and K-RAS/N-RAS mutations. The ex-China rights of BGB-283 are licensed to Merck KGaA.

About BeiGene

BeiGene is a global, clinical-stage, research-based company focused on targeted and immune-oncology therapeutics. With a team of 175+ scientists and staff, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions that will have both a meaningful and lasting impact on cancer patients. For more information, please visit our website at www.beigene.com. 

Reference

1. Sosman JA, Kim KB, Schuchter L, Gonzalez R, Pavlick AC, Weber JS, et al. Survival in BRAF V600–Mutant Advanced Melanoma Treated with Vemurafenib. New England Journal of Medicine. 2012;366:707-14.

2. Anforth R, Fernandez-Peñas P, Long GV. Cutaneous toxicities of RAF inhibitors. The Lancet Oncology. 2013;14:e11-e8.

3. Anforth RM, Blumetti TCMP, Kefford RF, Sharma R, Scolyer RA, Kossard S, et al. Cutaneous manifestations of dabrafenib (GSK2118436): a selective inhibitor of mutant BRAF in patients with metastatic melanoma. British Journal of Dermatology. 2012;167:1153-60.

4. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation. New England Journal of Medicine. 2011;364:2507-16.

5. Kopetz S, Desai J, Chan E, Hecht J, O'dwyer P, Lee R, et al. PLX4032 in metastatic colorectal cancer patients with mutant BRAF tumors. J Clin Oncol. 2010;28:3534.

CONTACT: Media/Investor Contact:
         Xin Huang
         US: +1 917-617-4653
         China: +86 185-1406-3050
         [email protected]

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