BeiGene gets CFDA approval to conduct clinical trial

BeiGene Ltd. (Beijing, China) said China FDA approved a clinical trial application (CTA) for BGB-283. The small molecule, second-generation BRAF inhibitor is BeiGene's first candidate to receive a CTA approval.

BeiGene said it plans to start its Chinese trial in 4Q15; the study will test BGB-283 in cancer patients with BRAF, K-Ras ( KRAS), or neuroblastoma Ras viral (v-Rase) oncogene (NRAS) mutations. Last month, BeiGene started a Phase Ib study in Australia and New Zealand of BGB-283 in solid tumor patients. BeiGene did not respond to inquiries. ...