WALTHAM, Mass., Aug. 18, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company focused on developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with BGB-290, a highly potent and selective PARP inhibitor. China is the third territory in which BGB-290 has received approval to conduct clinical trials, in addition to Australia and the United States. Data from the Phase I proof-of-concept trial of BGB-290 were previously presented at the 2015 AACR-NCI-EORTC conference.
“The CTA approval for BGB-290 represents the third molecule from the BeiGene portfolio to receive regulatory clearance for initiation of clinical trials in China. We look forward to commencing the development of BGB-290 in China, in addition to continuing global development of BGB-290, both as a monotherapy and in combination with BGB-A317, our PD-1 antibody,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman.
“The CTA approval for BGB-290 is supported by the progress that we have made so far in our trials in Australia, which were initiated in July 2014. We believe that BGB-290 is the first PARP inhibitor to be developed in China under the domestic regulatory pathway to enter the clinic globally,” said Wendy Yan, Head of Regulatory Affairs at BeiGene.
BGB-290 is a potent and highly selective inhibitor of PARP1 and PARP2. BGB-290 is being developed as a monotherapy and in combination with other therapies for the treatment of several cancers including ovarian cancer, prostate cancer, breast cancer, glioblastoma multiforme, small cell lung cancer, and gastric cancer.
BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 250 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the future clinical development and regulatory milestones of BGB-290. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
Lucy Li, Ph.D.
Source: BeiGene, LTD.