• This approval for XPOVIO^® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South Korea.
• To date, XPOVIO^® has already been included in national health insurance or reimbursement schemes in South Korea, the mainland of China, Australia and Singapore, and is expected to achieve national reimbursement coverage in more APAC markets.
• XPOVIO^® has been approved for multiple indications in nine markets across the APAC region. Antengene has submitted a new drug application (NDA) for XPOVIO^® in Indonesia with approval expected in the second half of 2024.

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a supplemental New Drug Application (sNDA) for XPOVIO^® (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.

Prior to the recent approval, XPOVIO^® has been approved for two indications in South Korea that are: in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM); and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). In July 2024, XPOVIO^® was included into the reimbursement drug list in South Korea, thus became the first XPO1 inhibitor approved for public insurance coverage in the country.

With a novel mechanism of action, XPOVIO^® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in nine countries and regions in APAC and included in the national insurance schemes in South Korea, the mainland of China, Australia, and Singapore. This recent approval for XPOVIO^® in South Korea will bring another innovative therapy to the clinical management of MM patients in South Korea, benefiting countless patients and families.

While bringing XPOVIO^® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO^®. Leveraging the drug's novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO^® for the treatment of various indications including myelofibrosis (MF), and endometrial cancer.