China-based oncology biotech BeiGene has received China FDA approval for a clinical trial application on small-molecule candidate BGB-283, a second-generation BRAF inhibitor, in the latest ramp-up across its pipeline this year since a successful funding round in May.
The approval marks BeiGene's first candidate to receive a CFDA clinical trial nod, with plans to start the trial in the fourth quarter of this year in cancer patients with BRAF, K-Ras (KRAS), or neuroblastoma Ras viral (v-Rase) oncogene (NRAS) mutations.
"We are delighted to receive CTA approval in China from the CFDA to start BGB283 clinical trials in China," John Oyler, CEO of BeiGene, said in a press release.
|BeiGene CEO John Oyler|
"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."
In July, it started a Phase Ib study in Australia and New Zealand of BGB-283 in solid tumor patients.
In June, BeiGene received U.S. FDA approval on an IND application for clinical development of BGB-3111, a proprietary Bruton tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies, putting a fresh round of funds to use as it works on three main oncology candidates. Also in June, BeiGene dosed the first patient in a Phase I study of BGB-A317, a humanized anti-PD-1 monoclonal antibody, for the treatment of advanced cancer.
In May, BeiGene said it had completed financing of more than CNY600 million ($97 million) from initial angel and strategic investors as well as new investors Hillhouse Capital and CITIC PE, joined by an unnamed "blue chip U.S. public investment fund" specializing in life sciences.
The oncology company is focused on developing targeted and immune-oncology therapeutics.
The company has set its sights on three small molecules in Phase I, BGB-283, a second-generation BRAF and EGFR inhibitor; BGB-290, a PARP inhibitor; as well as BGB-3111 among other candidates, including PD-ligand 1, for which AstraZeneca ($AZN) is conducting trials for MED14736 and Roche's ($RHHBY) Genentech for MPD3280A.
- here's the release (PDF)