Antengene Secures Expanded Approvals For Xpovio In Hong Kong Across Multiple Myeloma And DLBCL

04 December 2025 | Thursday | News


New sNDA decisions enable monotherapy and combination therapy use, strengthening access to the first approved XPO One inhibitor across three indications

- 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 ChinaTaiwan market, AustraliaSingapore and South Korea).

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 ChinaTaiwan market, AustraliaSingapore and South Korea). Moving forward, XPOVIO® is expected to receive public insurance coverage in more APAC markets.

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