BeiGene (06160) total revenue in the third quarter increased by 28% year-on-year to $1.02 billion.

BEIGENE (06160) released the financial results for the third quarter of 2024, with the group's net product revenue reaching $993 million, a year-on-year increase of 67%; total revenue of $1.002 billion, a year-on-year increase of 28%; and adjusted operating profit of $65.63 million. "The outstanding performance in the third quarter further demonstrates the company's leading position in the global oncology field, thanks to our unique research and clinical advantages, as well as the strong momentum of Bruklinze in the market," said Mr. John Oler, co-founder, chairman, and CEO of BEIGENE. "In the United States, Bruklinze has become the leader in the field of frontline and relapsed/refractory CLL, as well as in the treatment of all other approved B-cell malignancies. As the cornerstone of the company's hematology pipeline, Bruklinze has shown significant clinical therapeutic potential, whether as a monotherapy or in combination with the late-stage pipeline BCL2 inhibitor sonrotoclax and BTK degrader BGB-16673 as the best combination therapy in its class." "In the field of solid tumors, we are expanding the global accessibility of the PD-1 inhibitor Bazeeran, building and continuously deepening global commercial capabilities to advance many exciting potential anticancer drugs. At the same time, we are laying the foundation for expanding into the breast cancer, lung cancer, and gastrointestinal cancer fields through our three core platform technologies of bispecific antibodies, protein degraders, and antibody-drug conjugates. This progress not only demonstrates our achievements but also confirms our commitment to positively impacting the lives of patients globally, bringing hope and progress in the fight against cancer." Bruklinze is an orally available Bruton's tyrosine kinase (BTK) small molecule inhibitor designed to achieve sustained and complete inhibition of BTK protein by optimizing bioavailability, half-life, and selectivity. With pharmacodynamic characteristics that differentiate it from other approved BTK inhibitors, Bruklinze has been shown to inhibit malignant B-cell proliferation in various disease-related tissues. Bruklinze is the most widely approved BTK inhibitor globally and the only one that can be dosed flexibly once daily or twice daily. The global clinical development program of Bruklinze has conducted over 35 trials in more than 30 countries and regions, with approximately 6,000 patients enrolled. Bruklinze has been approved in over 70 markets globally, with over 100,000 patients treated. In the third quarter of 2024, Bruklinze sales in the United States reached $504 million, an 87% year-on-year growth, with over 60% of the quarterly sequential demand growth coming from the extensive use in the chronic lymphocytic leukemia (CLL) market, mainly due to the continuous increase in market share for new CLL patients. In the third quarter of 2024, Bruklinze sales in Europe reached $97 million, a 217% year-on-year growth, primarily driven by market share gains in all major markets including Germany, Italy, Spain, France, and the United Kingdom. The 5-year follow-up results of the Phase 3 SEQUOIA study cohort 1 show that the use of Bruklinze in treatment-naive (TN) CLL or small lymphocytic lymphoma (SLL) patients demonstrates a sustained benefit in progression-free survival (PFS), with a 80% PFS rate at 54 months, and no new safety signals were identified; detailed data will be presented at the 2024 American Society of Hematology (ASH) Annual Meeting. The 5-year follow-up data of the BOVen study (zubutinib, otuzumab, venetoclax) for treating TN CLL patients show that 96% of patients in peripheral blood and 92% in bone marrow did not detect minimal residual disease (uMRD), and uMRD was persistent, with a median MRD-free survival of 34 months; detailed data will be presented at the 2024 ASH Annual Meeting. Bazeeran (trelziromab) is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein-1 (PD-1) monoclonal antibody with high affinity and specificity for binding to PD-1; its design minimizes binding to Fc receptors on macrophages, helping the body's immune cells recognize and kill tumor cells. Bazeeran is the cornerstone product of BEIGENE's solid tumor product portfolio and has shown potential in various types of tumors and disease areas. The global clinical development program of Bazeeran has conducted 66 trials in 34 countries and regions, including 20 registrational studies, with approximately 14,000 subjects enrolled. Bazeeran has been approved in 42 countries and regions, with over 1.3 million patients treated globally.