May 7, 2025 — BeiGene announced its Q1 2025 US financial report and A-shares performance report, with revenue of RMB 8.048 billion, a 50.2% year-on-year growth. Product revenue continued to show strong growth, reaching RMB 7.985 billion, up 49.9%.
The revenue growth was primarily driven by its core self-developed products, BeiYueZe? (zanubrutinib) and BeiZeAn? (tislelizumab), as well as sales growth of Amgen-licensed products.
In terms of financial performance, in Q1 2025, BeiGene achieved significant progress in profitability, driven by rapid global revenue growth and effective management of operating expenses. According to the A-share performance report, the company achieved operating profit and total profit, turning from a loss to a profit. Meanwhile, the US GAAP financial report shows that BeiGene achieved its first quarterly profit, with significantly improved operating cash flow, marking a turning point in its development.
Looking ahead to 2025, BeiGene maintains its financial guidance, expecting annual revenue to be between RMB 35.2 billion and RMB 38.1 billion, including expectations for strong growth driven by BeiYueZe?'s leading position in the US and its continued expansion in Europe and other key global markets. At the same time, the company reaffirms its expectation for positive operating profit and positive operating cash flow.
BeiGene's Co-founder, Chairman, and CEO, John V. Oyler, stated, "This quarter, we achieved excellent results, with our first GAAP quarterly profit and continued global revenue growth. In the US, BeiYueZe? continues to lead in new patient treatment in chronic lymphocytic leukemia (CLL) across all treatment lines, and for the first time, it has become the market leader in the overall BTK inhibitor market share. We are making significant progress in our late-stage hematologic and solid tumor pipeline and expect to see proof-of-concept (PoC) data readouts this year across a wide range of programs, including antibody-drug conjugates, bispecific antibodies, and targeted protein degraders. Our financial momentum is strengthening, and our global, diversified business has now expanded to six continents. With our new English name, BeOne Medicines, and our registration in Switzerland, we are well-prepared to move forward toward becoming one of the most influential oncology innovation companies globally."
During the reporting period, BeiGene's core self-developed BTK inhibitor, BeiYueZe? (zanubrutinib), saw strong demand growth, with global sales reaching RMB 5.692 billion, a 63.7% increase. In the US market, zanubrutinib sales reached RMB 4.041 billion, up 61.9%. Currently, zanubrutinib is the leader in the treatment of new patients in CLL and all other approved indications in the US, with its market share continuing to rise. The financial report also shows that zanubrutinib has for the first time achieved the top market share in the US BTK inhibitor field.
In addition, zanubrutinib performed very well in other markets. Its sales in Europe reached RMB 836 million, up 75.4%, primarily due to increased market share across all major European markets, including Germany, Italy, Spain, France, and the UK. In China, zanubrutinib sales reached RMB 590 million, a 43.1% increase, maintaining its leading position.
Notably, in 2024, zanubrutinib ranked 20th in global oncology drug sales with USD 2.6 billion, becoming one of the "global blockbuster drugs." Currently, zanubrutinib is approved in 75 markets globally, and this quarter, it was included or expanded in reimbursement coverage in 11 new markets, continuously improving patient accessibility.
In the field of hematologic oncology, besides zanubrutinib, BeiGene is building a comprehensive product pipeline through the development of subsequent BCL2 inhibitor Sonrotoclax and BTK CDAC BGB-16673.
Currently, the potential "best-in-class" BCL2 inhibitor Sonrotoclax has entered the registrational clinical trial phase. The financial report indicates that the global Phase III clinical trial of Sonrotoclax combined with zanubrutinib for first-line treatment of CLL has completed patient enrollment; the Phase III trial for the treatment of R/R mantle cell lymphoma (MCL) has completed the enrollment of the first patient. Meanwhile, the company is advancing the global Phase II clinical trial of Sonrotoclax for the treatment of Waldenstr?m's macroglobulinemia (WM).
Recently, the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) officially accepted Sonrotoclax's New Drug Application (NDA), and it has been included in the priority review process for treating previously treated adult CLL/SLL patients. Additionally, the company plans to report data from the Phase II clinical trial for R/R MCL and is expected to submit a global potential accelerated approval application for this indication in the second half of 2025.
The BTK degrader BGB-16673 has also shown treatment advantages in the covalent BTK-treated population, and it is expected to significantly alleviate the issue of BTK resistance. BGB-16673 is currently the fastest progressing BTK degrader in clinical trials, and BeiGene has initiated a Phase III clinical trial comparing BGB-16673 with the physician's choice treatment for R/R CLL. A Phase III clinical trial of BGB-16673 vs. the non-covalent BTK inhibitor pirtobrutinib for R/R CLL patients is expected to begin in the second half of 2025.
In Q1 2025, BeiZeAn? (tislelizumab) sales reached RMB 1.245 billion, a 19.3% year-on-year growth, mainly driven by the demand from new patients resulting from newly approved indications being included in the National Medical Insurance catalog in China, as well as an increase in the number of hospitals carrying the drug. Currently, tislelizumab is approved for 14 indications in China, 13 of which have been included in the national insurance catalog.
Globally, tislelizumab's registration strategy continues to progress. Recently, tislelizumab has been approved in Japan and Indonesia. It is now approved in 46 markets globally, with over 1.5 million patients treated. This quarter, tislelizumab was included in the reimbursement list in 11 additional markets, including the US, Europe, and China, benefiting more patients worldwide.
In solid tumors, BeiGene's product portfolio has expanded into a diversified pipeline, accelerating its focus on lung cancer, breast cancer, and gastrointestinal cancer through platforms such as multi-antibodies (bispecific antibodies), protein degraders, and ADCs. Ongoing pipeline programs include CDK4 inhibitors, PanKRAS inhibitors, B7 H4 ADCs, EGFR CDACs, and more.
The financial report shows that, for lung cancer, the Phase III clinical trial of AMG757 (DLL3 x CD3 bispecific T-cell engager) for second-line treatment of small cell lung cancer, conducted in collaboration with Amgen, has shown positive data readouts. At the same time, BeiGene expects to complete patient enrollment for the Phase III clinical trial of BGB-58067 (PRMT5 inhibitor) and BG-89894 (MAT2A inhibitor) in combination treatment by the second half of 2025.
For breast cancer and gynecological cancers, the company expects to obtain proof-of-concept data for BGB-43395 (CDK4 inhibitor) in the first half of 2025.
For gastrointestinal cancers, BeiGene expects to report primary PFS data from the Phase III clinical trial of Zenidatuzumab (HER2-targeting bispecific antibody) for first-line treatment of HER2-positive gastric/esophageal adenocarcinoma in the second half of 2025.
In terms of corporate development, BeiGene plans to hold an investor R&D day on June 26, focusing on the development of its breast cancer pipeline and broader solid tumor treatment portfolio. Additionally, the financial report indicates that BeiGene will adopt the new English name BeOne Medicines Ltd. (the Chinese name remains unchanged) and register in Switzerland, with related matters expected to be completed later this year.
