BeiGene plans wider footprint in China with Suzhou development site

BeiGene is moving to Suzhou, in part, with plans to branch out from its capital city headquarters and develop a novel oncology drug operation that includes a cGMP manufacturing facility in Suzhou's BioBAY, the company said in a press release.

Plans for a facility covering 97,000 square feet to be completed in 2017 include products for its own clinical trials as well as commercial sales, the company said.

Earlier this month BeiGene 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 company has 11 molecules in development focused on oncology, with three in preclinical development.

BeiGene CEO John Oyler

The China-focused biotech is among several firms increasingly busy in the oncology space pursuing in-licensed or original candidate development with an eye on both local approvals and abroad, putting the company in tune with official policy which this week stressed development of innovative drugs in cancer and other areas as priorities for approval.

For BeiGene, the approval of BGB-283 marks its 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.

In July, BeiGene 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 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 BeiGene release (PDF)