Antengene Corporation Limited, 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,  announced that the Malaysian National Pharmaceutical Regulatory Agency has approved a supplemental New Drug Application (sNDA) for XPOVIO^® (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least 2 lines of systemic therapy, who are ineligible for autologous stem cell transplant.

With this recent approval, XPOVIO^® has further expanded its portfolio of approved indications in Malaysia, bringing the total to three indications across multiple myeloma (MM) and DLBCL, two major therapeutic areas in hematology. Prior to this, XPOVIO^® was approved in Malaysia for two indications, including in combination with bortezomib and dexamethasone for the treatment of adult patients with MM who have received at least one prior therapy; and in combination with dexamethasone for the treatment of adult patients with MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The latest indication expansion into DLBCL will allow XPOVIO^® to benefit a broader population of patients, offering new hope and a meaningful treatment option for patients and families who have been urgently seeking effective therapies.

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.