BeiGene has broken ground on its flagship U.S. manufacturing and clinical R&D center in New Jersey as it branches out in a global expansion.
The new 42-acre site, located at the Princeton West Innovation Campus in Hopewell, marks BeiGene’s first plant outside of China. Its construction comes as BeiGene nears an FDA decision for the Novartis-partnered PD-1 inhibitor tislelizumab.
BeiGene already has contract manufacturers to help make its medicines, but an in-house facility is a “strategic asset,” especially in biologics, because having control offers flexibility, CEO John Oyler said.
“I think it's important to the world now, given the way supply chain issues occured during COVID, that you have a number of geographies in which you're manufacturing” to offer supply certainty to patients in all countries, Oyler said in an interview with Fierce Pharma Manufacturing.
The initial phase of the New Jersey project includes about 400,000 square feet of biologics manufacturing space and 16,000 liters of capacity. The entire property will contain more than one million square feet of developable real estate, allowing for potential future expansions.
The company expects to wrap up construction of the first phase mid-2023. It plans to hire “hundreds” of employees from the area immediately.
BeiGene attracted Novartis to a tislelizumab partnership in North America, Europe and Japan in 2021. Already approved in China in multiple indications, the checkpoint inhibitor is nearing an FDA target date of July 12 for its initial U.S. application in previously treated esophageal squamous cell carcinoma.
If approved, it would be BeiGene’s first biologic product in the U.S. The company already sells small-molecule BTK inhibitor Brukinsa for certain blood cancers in the U.S.
Novartis has rights to manufacture tislelizumab in the U.S., per the two companies’ agreement. But BeiGene will handle “a specified percentage of production” at the New Jersey site, according to a recent securities filing. Oyler confirmed that BeiGene intends to make tislelizumab out of the Hopewell site.
Amid its expansion push, BeiGene’s U.S. efforts are currently clouded by a potential risk to be delisted from the U.S. stock market. BeiGene, along with a growing list of over a dozen other companies with China roots, have been dinged by the U.S. Securities and Exchange Commission because a U.S. audit watchdog couldn’t inspect their books.
Taking steps to be compliant with the Holding Foreign Companies Accountable Act and avoid delisting, BeiGene just switched its accounting firm to Ernest & Young in Boston from a China-based E&Y operation for its 2022 reporting. Regulators in Beijing and Washington are also reportedly working on a solution to their conflicting audit laws.
“We've addressed the issue,” Oyler said of the BeiGene's new auditor. Unlike some other companies on the SEC warning list that are owned and operated by people in China and happened to be listed in the U.S., BeiGene is a global organization, the CEO said.
BeiGene already operates from five offices in the U.S. Besides Cambridge, Massachusetts, it also has operations in San Mateo and Emeryville, California, plus Ridgefield Park, New Jersey, and Fulton, Maryland. Aiming to be a global biopharma company, BeiGene has over 30 offices across five continents.
Co-founded by Oyler in China, BeiGene currently operates two manufacturing facilities in the country. Its 140,000-square-foot site in Suzhou manufactures small molecules and has some capacity to supply biologics for clinical development. BeiGene is currently building a larger 50,000-square-meter facility nearby to replace the current Suzhou site.
The company’s larger Guangzhou campus is responsible for the commercial-scale production of biologics. BeiGene has finished three phases of construction at the Guangzhou site and is plotting further expansion “from a global perspective” as its business grows, Oyler said.
Editor's Note: The story has been updated with additional comments from an interview with BeiGene CEO John Oyler