HOPEWELL, NEW JERSEY—A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics.
BeiGene debuted its flagship biologics manufacturing and R&D site in Hopewell, New Jersey, on Tuesday. The facility features about 400,000 square feet of commercial-stage production space, capacity for about two million vials per year and 125 employees. The campus, originally owned by Bristol Myers Squibb, has plenty of room to allow for further expansions over time.
“There’s a lot of companies that do not have biologic manufacturing capabilities,” Oyler said in an interview on the sidelines of the opening ceremony. “We view ourselves as someone who, over time, became a very high-quality biologic manufacturer.”
Oyler is leveraging BeiGene’s biologics experience to search for deals, like the one it signed with DualityBio for a preclinical antibody-drug conjugate (ADC).
“I don’t think that we’re as a company saying, ‘hey, let’s be a CDMO.’ That’s not really what we’re interested in,” Oyler said. “There’s ways that we could work together on co-development […] on co-commercialization, be one of two suppliers for a company, or be a company that helps an ADC company develop the process and the capabilities that we’re really good at.”
BeiGene has “full intention” to bring its ADC know-how to the new U.S. site, Oyler said.
“It’s just a question of when we decide to pull the trigger on that, and I think it’s based on the timing of the success of ADCs we’re putting in the clinic," the CEO explained.
BeiGene built the Hopewell site with flexibility and the future in mind, as the majority of BeiGene’s clinical or near-clinical pipeline assets are biologics.
“We worked very hard to make this a flexible, multiuse type of situation, so we can move quickly as the right opportunities rise, whether it’s in our own portfolio or from a collaboration partner,” BeiGene’s strategic adviser and special assistant to the CEO, Michael Schoen, said during a press briefing Tuesday.
Supporting the Tevimbra launch
The opening of the Hopewell site comes as BeiGene nears the launch of its first biologic product in the U.S., the PD-1 inhibitor Tevimbra. The drug scored its belated initial FDA approval in March in previously treated esophageal squamous cell carcinoma, and BeiGene is waiting for another possibly delayed decision in newly diagnosed patients.
Tevimbra’s initial FDA delay, which lasted for 20 months, showcased the importance of having a U.S.-based manufacturing site. For quite some time, the FDA was unable to inspect the drug’s plant in China because of COVID travel restrictions.
Besides Hopewell, BeiGene has a biologics facility in the Chinese city of Guangzhou. Boehringer Ingelheim has also been serving as the CDMO for Tevimbra since its first approval in China in late 2019.
Novartis also helps manufacture the PD-1 inhibitor outside of China despite the termination of its R&D and commercialization collaboration with BeiGene. But BeiGene plans to bring that responsibility fully in house “as soon as we possibly can” once the Hopewell site secures the FDA’s green light, Oyler said.
BeiGene's roots
While Oyler is keen on billing the Hopewell facility as a potential global partner for other biologics drug developers, it remains to be seen what effect BeiGene’s deep ties with China could have on smaller biotechs amid rising geopolitical tensions.
BeiGene became a commercial-stage drugmaker in 2017 when it acquired Celgene’s business in China, and China has been BeiGene sole or main revenue source until the BTK inhibitor Brukinsa took off in the U.S. last year. In 2023, BeiGene’s product sales were almost equally split between China and ex-China businesses.
Further, the major in-licensing collaborations BeiGene has signed are also heavily tied to China. A 2019 deal with Amgen gave BeiGene rights to several in-market and pipeline products in China. Another of the company’s partners, DualityBio, is also a Chinese biotech.
But as Oyler noted, China only came into play later in BeiGene’s operations.
BeiGene has been a Cayman company at inception. The team was formed originally in Valley Forge, Pennsylvania, and started with two assets in-licensed from Johnson & Johnson. The company then conducted clinical trials in Australia and other parts of Asia but not in China because China at that time didn’t have an amicable regulatory infrastructure for novel drug development, Oyler recalled.
“We don’t really see borders,” Oyler said. “We viewed ourselves from day one as an organization with a very clear goal to make globally relevant science [and] make highly impactful medicines for cancer patients.”
BeiGene signed the Celgene deal, which also included out-licensing of rights to Tevimbra, when it saw a tipping point in China’s shift toward innovative medicines, and because selling a PD-1 inhibitor in solid tumors would be too daunting a task for a small company to take on, Oyler explained.
China will always have an important role in BeiGene because the company’s goal is to get medicines not just to the wealthiest people but to as many people as it can, the CEO added.
“We believe that in this industry, if you really want to fit that mission, you have to be global,” Oyler said.