Zanubrutinib

BeOne Medicines said it will seek regulatory approvals in the US and elsewhere globally for sonrotoclax (BGB-11417), following the release of positive topline data from a Phase I/II trial in relapsed or refractory mantle cell lymphoma (MCL). The 125-patient study met its primary endpoint of overall response rate, positioning the next-generation BCL2 inhibitor for potential approval in the rare and aggressive form of blood cancer.The trial enrolled adult patients whose disease had progressed following treatment with anti-CD20 therapy and a BTK inhibitor. Results showed "clinically meaningful responses in this heavily pretreated population" and "promising results" across secondary endpoints including complete response rate, duration of response and progression-free survival, according to the company. Additionally, the safety profile was generally well-tolerated and "toxicities were manageable." Full data will be shared at an upcoming medical meeting."For people with relapsed or refractory mantle cell lymphoma, the disease is aggressive, the treatment landscape fragmented, and the outcomes unacceptably poor," remarked Lai Wang, BeOne's global head of R&D. Wang said the topline results "underscore [sonrotoclax's] potential to deliver meaningful and durable responses" for patients with relapsed/refractory MCL, which affects an estimated 28,000 people globally and has a five-year survival rate of approximately 50%.BeOne is already familiar with the MCL space through Brukinsa (zanubrutinib), its BTK inhibitor approved by the FDA for multiple B-cell malignancies, including second-line MCL in 2019. The drug, which generated sales of roughly $2.4 billion across the US and Europe in 2024, is also cleared for Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma.BeOne said new drug applications for sonrotoclax are already under review in China for both relapsed/refractory MCL and CLL/SLL. The company also launched earlier this year the Phase III confirmatory CELESTIAL-RR MCL study, which will evaluate sonrotoclax in combination with Brukinsa versus Brukinsa alone in an estimated 300 patients with relapsed/refractory mantle cell lymphoma.

Dive Brief:Royalty Pharma has grabbed rights to a share in revenue from lung cancer drug Imdelltra, announcing Monday it will pay $885 million upfront for BeOne Medicines royalties paid by partner Amgen for sales outside China. BeOne, formerly known as BeiGene, has rights to Imdelltra revenue because of a $2.7 billion collaboration deal it struck with Amgen in 2019.Per deal terms, BeOne has the option to sell another chunk of Imdelltra royalties in the next year for $65 million, bringing the deal total to around $950 million. Royalty said the initial royalty stream amounted to approximately 7% of worldwide net sales.Launched in 2024 for small cell lung cancer, Imdelltra earned sales of $215 million through the first six months of 2025, most of it in the U.S. under an accelerated approval from the Food and Drug Administration. Amgen recently reported data from a clinical trial showing the drug extends survival compared with chemotherapy, which should secure its place on the market.Dive InsightBeOne is now well established as a commercial drugmaker, recording total sales of $2.4 billion through the first six months of the year from drugs it developed as well as some of Amgens products in China. However, it also has significant expenses, burning about $2 billion over the same time about half on research and development of its own drugs like Brukinsa and sonrotoclax.That profit picture for the first half looks like it will be sustained for the full year, as BeOnes executives forecast positive operating income and cash flow even before this deal was announced. The deal will only build on that momentum, executives said Monday.A strong balance sheet is a hallmark of the most successful companies in our industry, and this transaction provides increased operational and strategic flexibility as we continue to execute our business strategy for the long term, said CFO Aaron Rosenberg, in a statement.A so-called bispecific antibody, Imdelltra triggers an immune response to cells expressing a protein called DLL-3, common among tumor cells in small cell cancer, a hard-to-treat disease that until recently has had few innovative treatments. While Merck & Co.s immunotherapy Keytruda and Bristol Myers Squibbs Opdivo have gained approval for small cell lung cancer, they were withdrawn when confirmatory data didnt support their use. Roches Tecentriq can be used in certain patients, however.Imdelltra is reshaping the treatment paradigm for patients with small cell lung cancer, a highly aggressive disease with few treatment options, said Pablo Legorreta, Royaltys CEO, in a statement. Todays transaction is consistent with our strategy of acquiring royalties on highly transformative products in life sciences.Royalty Pharma has been active in buying revenue streams recently, striking deals with Biogen, Cytokinetics, Sanofi and Agios. '