In 2022, BeiGene’s product revenues reached $1.25 billion, up nearly 100% from $634 million in 2021. BTK inhibitor Brukinsa continued to expand in blood cancer, with its 2022 sales swelling 159% to $565 million. And amid fierce PD-1/L1 competition in China, tislelizumab managed a 66% sales increase to $423 million. Looking forward, both meds face important commercial tests. In January, Brukinsa won an FDA approval to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), currently the largest indication for BTK inhibitors. In CLL, the drug boasts a head-to-head phase 3 win against AbbVie and Johnson & Johnson’s market-leading Imbruvica. In previously treated CLL patients, Brukinsa showed it was better than Imbruvica in shrinking tumors. BeiGene is working with the FDA to get updated progression-free survival data into the drug’s label. At peak, the BeiGene drug could hit $3.1 billion in CLL alone and about $5.1 billion across indications, SVB Securities analysts wrote in a January note to clients. BeiGene has grown its commercial presence in the U.S. and has been expanding in Europe substantially over the last two years, BeiGene CEO John Oyler said in an interview on the sidelines of the American Society of Hematology annual meeting in December. “Really for us, the build-out over the next two years is really about trying to get to the 60-plus countries we’re approved in,” Oyler said, noting that BeiGene prefers to have its own commercial team supporting its launches. RELATED Look out, AbbVie and J&J. BeiGene's Brukinsa just scored a key leukemia nod to take on Imbruvica While Brukinsa’s blockbuster future now rests on commercial execution, tislelizumab’s path looks more uncertain. Thanks to COVID-19, the FDA couldn’t inspect a Boehringer Ingelheim facility in China as part of tislelizumab’s application in previously treated esophageal squamous cell carcinoma (ESCC). In BeiGene’s fourth-quarter earnings report on Monday, the company said it’s “facilitating the scheduling” of the inspections as soon as possible. A regulatory decision is expected in 2023, BeiGene said, without providing a more specific timetable. The company’s partner on tislelizumab, Novartis, recently projected an FDA decision in the second half of 2023. Further, BeiGene said it will support Novartis’ planned FDA submission for tislelizumab in first-line gastric cancer and first-line unresectable ESCC this year. In the PD-1/L1 arena, BeiGene has pointed to stomach cancer as a field where the drug could compete. But recently released phase 3 data don’t bode well for its potential expansion there. In data presented last month, tislelizumab plus chemotherapy helped patients with newly diagnosed stomach cancer live significantly longer than chemo alone. But the benefit was only observed in patients with PD-L1-positive tumors. The tislelizumab-chemo combo cut the risk of death by 26% over chemo alone in PD-L1-positive, HER2-negative gastric or gastroesophageal junction cancer, according to data from the phase 3 RATIONALE-305 trial presented at the 2023 ASCO Gastrointestinal Cancers Symposium in January. The trial enrolled PD-L1-negative patients, with all-patient overall survival serving as the other primary endpoint. The study remains ongoing as it nears a final overall survival analysis. Results are expected later this year. If tislelizumab fails to demonstrate a statistically significant survival improvement in a PD-L1-inclusive population, that would put the drug in a weaker position than Bristol Myers Squibb’s Opdivo and Merck’s Keytruda. RELATED BeiGene CEO touts 'strategic asset' in flagship US site and a fix to stock delisting risk As BeiGene and Novartis continue to wait for the FDA’s decision, tislelizumab has continued to grow in the ultracompetitive China market, with nine indications covered under national policy after the latest drug price negotiations in January. Tislelizumab is the leading PD-1 in China by market share and value, Oyler said in December. But because of limits to potential growth in China, a U.S. expansion is crucial for BeiGene.