Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.China-based oncology firm BeiGene has received clinical trial application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct Phase I trials of a new RAF dimer inhibitor, BGB-283, to treat solid tumors that harbor B-RAF mutations or other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.
Subscribe to our email newsletter
The trials 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.
In addition, BGB-283 will be evaluated in patients with K-RAS/N-RAS mutated cancers.
BeiGene CEO John Oyler said: "We are delighted to receive CTA approval in China from the CFDA to start BGB-283 clinical trials in China.
"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 company noted that the ongoing clinical trials of BGB-283 in other countries have showed a good safety profile, along with promising early anti-tumor activities.