XPOVIO® Approved in Hong Kong for Two Additional Indications in Multiple Myeloma and Diffuse Large B-Cell Lymphoma
- XPOVIO® (selinexor) has received approvals for three indications in Hong Kong. These include its previous approval as the treatment for multiple myeloma (MM) when used together with dexamethasone (Xd), and its recent approvals as a monotherapy for relapsed or refractory diffuse large B-cell lymphoma (R/RDLBCL) and as a combination therapy when used together with bortezomib and dexamethasone (XVd) for MM patients who received at least one prior therapy. - XPOVIO® is the first approved XPO1 inhibitor in Hong Kong. With expanding indications in MM and DLBCL, XPOVIO® is set to benefit more patients in Hong Kong. - XPOVIO® has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). SHANGHAI and HONG KONG, Dec. 3, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, today announced that the Department of Health, the Government of the Hong Kong Special Administrative Region (HKSAR) has approved two supplemental New Drug Applications (sNDA) for XPOVIO® (selinexor): in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy; and XPOVIO® as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant. To date, XPOVIO® has been approved in Hong Kong for three indications. Previously, the XPOVIO® Xd regimen was approved in Hong Kong for the treatment of relapsed/refractory multiple myeloma (R/R MM) in adult patients. The approval of the two additional indications will further expand its coverage of a broader patient population and provide survival benefits to more patients in need. With a novel mechanism of action, XPOVIO® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). Moving forward, XPOVIO® is expected to receive public insurance coverage in more APAC markets. About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages and includes several in-house discovered programs, including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 × 4-1BB bispecific antibody), ATG-031 (CD24-targeting macrophage activator), and ATG-042 (oral PRMT5-MTA inhibitor). Antengene has also developed AnTenGager™, a proprietary T cell engager 2.0 platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies indications. To date, Antengene has obtained 32 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald LungE-mail: donald.lung@antengene.com BD Contacts:Ariel GuoE-mail: ariel.guo@antengene.com
2025-12-03