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BeiGene Approved To Start Clinical Trials In China

Published 08/22/2016, 10:43 AM
Updated 03/09/2019, 08:30 AM

BeiGene Ltd. (NASDAQ:BGNE), a clinical-stage pharmaceutical company centered on developing innovative molecularly-targeted and immune-oncology drugs for cancer treatment, recently revealed that it has received Clinical Trial Application approval from the China Food and Drug Administration to initiate clinical trials in China with BGB-290. The drug is a highly effective and selective PARP inhibitor.

China is the third region in which BGB-290 has obtained approval to conduct clinical trials, in addition to Australia and the United States. Meanwhile, data from the Phase I proof-of-concept trial of BGB-290 were previously disclosed at last year’s 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,” explained 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,” Head of Regulatory Affairs at BeiGene, Wendy Yan stated.

What is BGB-290?

BGB-290 is being developed as a monotherapy as well as in combination with other therapies for the treatment of various cancers such as ovarian cancer, prostate cancer, breast cancer, glioblastoma multiforme, small cell lung cancer, and gastric cancer.

BeiGene is conducting research on the cancer drug with a team of more than 250 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan. The company is boosting a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer.

The biopharmaceutical firm is making an effort to provide combination solutions intended to have both a meaningful and lasting effect on cancer patients.

A recent press release shows positive statements regarding the future clinical development and regulatory breakthroughs of BGB-290. Actual outcomes may differ substantially from those indicated in the statements as a result of numerous crucial factors, including BeiGene’s ability to illustrate the efficiency and safety of its drug candidates. The clinical evaluation of its drugs, which may not support further development, could also have an impact on the final results.

BeiGene Stock Update

BeiGene Ltd. recently announced its quarterly earnings report. The company posted earnings of $0.73 per share for the quarter, beating average estimates of $0.68. Meanwhile, the drug maker reported a revenue of $40 million for the quarter, compared to analysts’ forecasts of $2.08 million. BeiGene’s revenue lost 71.4 percent on a year over year basis.

On the other hand, the company has an existing market capitalization of $662.22 million. BeiGene has a 1-year low of $22.51 and a 1-year high of $35.60, while it has a 50 day moving average of $28.41 and a 200 day moving average of $28.74.

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