BeiGene is taking over manufacturing for its China-approved PD-1 checkpoint inhibitor thanks to a new approval for a massive biologics factory.
The China National Medical Products Administration (NMPA) gave BeiGene the green light to start commercial manufacturing of the monoclonal antibody tislelizumab from the plant in Guangzhou. Work will kick off immediately, BeiGene said in a release. Until now, the company has relied on Boehringer Ingelheim to supply the drug in China through the country’s Marketing Authorization Holder (MAH) program.
BeiGene started work on its first in-house biologics plant in Guangzhou back in 2017. The facility stands at more than 1 million square feet—roughly the size of 21 football fields—and right now boasts 8,000 liters of commercial biologics capacity. By the end of next year, BeiGene says it will lift total capacity at Guangzhou to a whopping 64,000 liters.
After that, the company plans further expansions to lift capacity, a BeiGene spokesperson said via email. The plant is slated to have annual capacity in excess of 120,000 liters after a fourth round of construction, and the number could go as high as 200,000 liters, the spokesperson added. That would make it the largest facility of its kind in China.
The company currently employs 450 people at the plant and expects to grow its workforce there to more than 900 employees by 2023, the spokesperson said.
“Our Guangzhou site was never meant to be a China manufacturing base only,” the spokesperson said. “By building the capabilities in-house, we can strategically reduce our reliance on third-party manufacturing, which creates a cost, speed and flexibility advantage that allows us to efficiently scale as we transition our robust research pipeline into commercial-stage medicines.”
BeiGene expects the facility to become the first paperless biomanufacturing plant in China. The site incorporates cutting-edge tech like 3D modeling, digital twinning, augmented interfaces and artificial intelligence. BeiGene wrapped up its first tranche of construction and received validation on the plant in 2019.
Tislelizumab is the first product cleared for commercial production at the facility. The drug scored its first approval in China in late 2019 as a third-line treatment for classical Hodgkin lymphoma.
Since then, it’s racked up nods in previously treated, PD-L1-high bladder cancer and in conjunction with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer.
The drug has caught the attention of Swiss pharma Novartis, which early this year shelled out $650 million for marketing rights in the U.S., EU and Japan. Under the terms of the deal, which include up to $1.55 billion in milestones, BeiGene has the option to chip in on U.S. commercialization.
“We always wanted to be sure if we considered a partner that we would also be building capabilities for commercial in solid tumors alongside them,” BeiGene CEO John Oyler told Fierce Pharma in January. The deal would help BeiGene learn “how to commercialize and build some capabilities” outside its home base, he added.
While tislelizumab faces a crowded PD-1/L1 field in China and beyond, the checkpoint inhibitor could fare well in Asia-prevalent cancer types like gastric cancer, liver cancer or esophageal cancer—all areas without much competition, Oyler said.
Meanwhile, the antibody’s initial approval marked a big win for Boehringer Ingelheim, making it first CDMO to produce an approved drug under China’s Marketing Authorization Holder system. The MAH program eases the process for ex-China companies to apply for and hold approvals in-country. BI teamed up with BeiGene on tislelizumab in 2013.