BeiGene grows global workforce by 1,000-plus as Brukinsa surges, Tevimbra launches outside China

The chilling wind of the biotech winter has apparently spared BeiGene. While layoffs have been commonplace in the industry, BeiGene employed 1,400 more people at the beginning of 2024 than it did a year ago.

As of Feb. 14, BeiGene counted 10,600 full-time employees worldwide, including 1,600 in the U.S., the company’s annual securities filing shows. Last January, the company employed 9,200 staffers in total, with 1,300 working in the U.S.

The global expansion came as BeiGene’s product sales climbed 75% year over year to reach $2.2 billion in 2023.

The company has yet to turn a profit. But BeiGene did narrow its corporate loss by a third to $1.2 billion, mainly thanks to a settlement with Bristol Myers Squibb around the rights to certain legacy Celgene products in China.

BTK inhibitor Brukinsa contributed the lion’s share of BeiGene’s sales growth, and PD-1 inhibitor tislelizumab recently won its first approval outside China, scoring an EU nod for previously treated esophageal cancer in September. But a few uncertainties lie in BeiGene’s portfolio.

The company’s star commercial medicine, Brukinsa, more than doubled sales and crossed the blockbuster threshold to hit $1.3 billion in full-year sales. BeiGene attributed an 18% surge in selling, general and administrative expenses primarily to continued investment in Brukinsa’s rollout in the U.S. and Europe.

Brukinsa’s expansion comes at the expense of AbbVie and Johnson & Johnson’s first-to-market Imbruvica. In 2023, AbbVie reported that revenues for Imbruvica dropped 21% year over year to $3.6 billion. Meanwhile, AstraZeneca’s rival blood cancer med Calquence grew revenues by 22% in 2023, reaching $2.5 billion in sales.

The more Brukinsa grows, the more concerned investors are about a patent infringement lawsuit from AbbVie. Promising to “vigorously defend” itself against the suit, BeiGene in November filed a post-grant review petition with the U.S. Patent and Trademark Office, challenging the AbbVie patent involved. The two companies have put the lawsuit on halt pending resolution of the regulatory battle.

In another hurdle for the company, Novartis and BeiGene in September canceled a collaboration agreement around tislelizumab amid a protracted FDA review and an increasingly crowded PD-1 market. The separation left BeiGene alone to navigate a potential launch in the U.S., although the company didn’t rule out the possibility of finding a new partner.

The FDA was originally set to decide on tislelizumab as a second-line treatment for esophageal squamous cell carcinoma in July 2022. The agency at that time chalked up the delay to the inability to perform inspections in China because of COVID-19 restrictions.

BeiGene in July 2023 said the FDA had completed its on-site inspection. But another seven months have passed, and an FDA decision remains elusive. Monday, BeiGene estimated that a potential FDA approval for tislelizumab could come in the first half of 2024. Separately, the company has filed for a first-line approval; that filing carries a target decision date in July.

As tislelizumab struggles at the FDA, the drug in September earned its first EU nod in second-line esophageal cancer under the brand name Tevimbra. BeiGene hasn’t recorded any Tevimbra sales following the EU nod. The drug’s $537 million in sales in 2023—a 27% increase compared with the prior year—came entirely from China.

On Thursday, drug reviewers at the European Medicines Agency recommended the approval of tislelizumab across three non-small cell lung cancer indications. Besides an indication for use in combination with chemo for the first-line treatment of squamous NSCLC, the drug got backing for first-line nonsquamous NSCLC but only for those with high expression of PD-L1 on at least 50% of tumor cells. The third indication is for monotherapy in post-chemo NSCLC.

The EMA recommendation shows tislelizumab under a different brand name, Tizveni (PDF), in NSCLC. That name was originally used by Novartis in its filing, a BeiGene spokesperson told Fierce Pharma. Once the European Commission signs off on the NSCLC indications, BeiGene will merge the authorizations by middle of the year and launch under the brand name Tevimbra, the spokesperson said.

With its products reaching markets outside China, BeiGene is building a new, $800 million biologics manufacturing and R&D facility in Hopewell, New Jersey. The expansion is nearing completion and is expected to be operational in July, BeiGene said Monday.

Editor's Note: The story has been updated with more information on tislelizumab's brand name.