China's BeiGene snaps up Pfizer executive to run manufacturing ops

China oncology biotech BeiGene has snapped up Changzhen Wu to head a manufacturing operation that is in the process of outfitting a major facility in Suzhou, building on another key hire snatched from WuXi AppTec ($WX) to build out a formidable team.

Wu will head the cGMP manufacturing facility in Suzhou's BioBAY, BeiGene said in a release. The operation was announced in August as part of the company's plans to branch out from its capital city headquarters and develop a novel oncology drug operation.

The hire is a major one for BeiGene given Wu's more than decade-long stint as the head plant manager at Pfizer's ($PFE) operation in WuXi, as well as his work overseeing construction of the Pharmacia oncology manufacturing operations in China. Wu also has 15 years as the chief engineer at Sino-Sweden Pharmaceutical.

John Oyler, CEO of BeiGene

"Changzhen is an extremely valuable addition to our team," John Oyler, CEO of BeiGene, said in the release. "He is very well respected and has many established relationships in the industry. His unparalleled knowledge in the production of small-molecule drugs, and overseeing plant construction to managing day to day operations, is a strong complement to our existing team and critical to our future strategies."

BeiGene recently hired former vice president and head of site at WuXi AppTec, Jinyou Zhang, as a senior vice president and head of bioprocess development, as plans for a 97,000-square-foot facility to be completed in 2017 get underway, the company said in a previous news release.

Also in August, 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.

The China-focused biotech is among several that are increasingly busy in the oncology space pursuing in-licensed or original candidate development with an eye on approvals local 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. The company plans to start the trial in the fourth quarter 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 patients with solid tumors.

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; and 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)

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