No longer a fledgling biotech, oncology-focused BeiGene, originally created in China in 2010 with the idea of carrying out world-class research there, has since expanded its global reach and garnered approvals for its therapies Brukinsa and Tevimbra. The company is on a growth trajectory with product sales reaching USD 2.2 billion in 2023 and staff numbers rising, yet it has run into some obstacles, namely a delisting threat from the US SEC, a lost partnership with Novartis, and an AbbVie lawsuit.


We have solidified our leadership in hematology with the continued success of Brukinsa’s global launch, led by US and Europe

John V. Oyler, chairman, co-founder, CEO


Sales Growth; Brukinsa Success

While BeiGene is not yet a profitable company, it showed more than positive financial results for 2023 with revenues reaching USD 2.5 billion, up from USD 1.4 billion in 2022, and product revenues totaling USD 2.2 billion, a 75 percent year on year increase. These results were largely due to its BTK inhibitor Brukinsa, which achieved global sales of USD 1.3 billion in 2023. “We have solidified our leadership in hematology with the continued success of Brukinsa’s global launch, led by US and Europe,” said chairman, co-founder and CEO John V. Oyler.


Growth in Staff Numbers, US Expansion, SEC Threat

Beyond its optimistic financial outlook, the Hong Kong-listed company has broadened its workforce. Employing 1,400 more staff at the beginning of this year than it did a year ago, the biotech’s headcount is now 10,600 worldwide, including 1,600 in the US.

BeiGene is also continuing its global expansion, particularly in the US where it is building a biopharmaceutical manufacturing and R&D site worth some USD 700 million, which is expected to be up and running by July. According to the company, the new campus will have about 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing space.

“The progress we are making in building our flagship US biologics manufacturing and R&D facility … is especially important to BeiGene as we continue to expand our global business through new approvals, including the FDA’s recent approval of Brukinsa for adult patients with CLL in the US,” said Oyler.

The US has been on BeiGene’s expansion radar for some time and the company, having created a BeiGene USA subsidiary, already operates five offices in the country in addition to its 30+ offices across the world and its manufacturing sites in Suzhou and Guangzhou, China. BeiGene’s American expansion efforts were complicated, however, when the US Securities and Exchange Commission (SEC) threatened to delist China-based companies like BeiGene from the Nasdaq because of a lack of access to their books. The company has taken steps to comply to the commission’s rules. “We’ve addressed the issue,” Oyler said, claiming that unlike other firms operating out of China and listed in the US, BeiGene is a global organization.


Fraught Tevimbra Partnerships

Other key assets for BeiGene include Tevimbra (tislelizumab), an anti-PD-1 antibody which has received approval from the European Medicines Agency (EMA) for advanced or metastatic esophageal squamous cell carcinoma (ESCC), and for which the firm has made two attempts to partner.

The 2021 global rights agreement BeiGene signed with Novartis was cancelled last year and BeiGene recovered the rights for the therapy. BeiGene expects an FDA green light in the first half of 2024, but without a larger partner the biotech may face a difficult entry in a space where eight other PD-1/L1 therapies have already been approved for different types of tumors.

The Novartis deal was not the first time BeiGene attempted to partner over Tevimbra. The company’s previous partnership with Celgene fell through in 2019 when the company returned the drug due to its merger with BMS and its conflicting asset Opdivo.


AbbVie Lawsuit

Another grey cloud for BeiGene is the patent infringement lawsuit AbbVie’s Pharmacyclics took out last year contending that Brukinsa, has been approved in over 65 markets, infringes a patent on its blood cancer drug Imbruvica.

“It is an unfortunate but rather regular occurrence that companies make allegations that a competitive product potentially infringes their intellectual property rights, even more so in response to a clearly differentiated medicine for cancer patients as Brukinsa,” BeiGene contended in a statement. This differentiation was proved when Brukinsa showed better efficacy and fewer side effects than Imbruvica in a head-to-head comparison study of the two therapies.

But the damage had been done and when the lawsuit was initially announced, the value of BeiGene’s stocks in Hong Kong and the Chinese mainland dropped by more than 10 percent.


Entry into Cell Therapy Now an Exit

Another recent development at BeiGene was the biotech’s decision to end its agreement with Shoreline for the iPSC-NK cell technology the company had previously dubbed as its “entry into cell therapy.” Having paid USD 45 million upfront in January 2022, BeiGene cited a strategic portfolio review as the reason behind the decision.

Without the Shoreline partnership, under which Shoreline and BeiGene were working to create cell therapies for four therapeutic targets, the firm loses the possibility of expanding its pipeline into cell therapy.

But BeiGene has not stopped expanding on other pipeline fronts, such as its early-stage breast cancer portfolio. At the end of last year, the firm struck a deal worth USD 1.3 billion with the US-based biotech Ensem Therapeutics, obtaining the global license for its oral cyclin-dependent kinase-2 (CDK2) inhibitor that is ready to enter early-stage trials.