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.
SHANGHAI and HONG KONG, Oct. 18, 2024 /PRNewswire/ — 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.
About XPOVIO® (selinexor)
XPOVIO® is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.
By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia.
Forward-looking statements
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