XPOVIO® (selinexor) Gains Third Approval in South Korea for MM

Antengene Corporation Limited, a prominent biopharmaceutical company headquartered in Shanghai and Hong Kong, has announced that its drug XPOVIO® has been granted approval by the South Korean Ministry of Food and Drug Safety (MFDS) for an additional use. This supplemental New Drug Application (sNDA) approval allows XPOVIO®, in combination with bortezomib and dexamethasone, to be used for adult patients with multiple myeloma (MM) who have undergone at least one previous therapy.

Prior to this new approval, XPOVIO® had already been authorized in South Korea for two specific uses: combined with dexamethasone for treating relapsed or refractory multiple myeloma (R/R MM) and as a standalone treatment for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). In July 2024, XPOVIO® was included in South Korea's reimbursement drug list, making it the first XPO1 inhibitor to be covered by public insurance in the country.

XPOVIO® stands out due to its unique mechanism of action. As the first approved orally-available, selective inhibitor of the nuclear export protein XPO1, it has gained approval in nine countries and regions within the Asia-Pacific (APAC) area. Its inclusion in national insurance plans in South Korea, Mainland China, Australia, and Singapore underscores its growing acceptance and utilization. The latest approval in South Korea is expected to enhance the clinical options available to MM patients, providing significant benefits for patients and their families.

Antengene is keen on extending the reach of XPOVIO® across more APAC markets and is also actively working on expanding its indications. By leveraging XPOVIO®'s novel mechanism, the company is developing various combination regimens to treat conditions such as myelofibrosis (MF) and endometrial cancer.

XPOVIO® functions by blocking the nuclear export protein XPO1, which results in the accumulation and activation of tumor suppressor proteins and growth-regulating proteins within the nucleus, while simultaneously reducing the levels of multiple oncogenic proteins. This mechanism allows XPOVIO® to exert its antitumor effects through three key pathways: inducing the intranuclear accumulation of tumor suppressor proteins, reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs, and restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. Consequently, XPOVIO® is being evaluated in numerous combination regimens for a variety of indications.

Currently, Antengene is conducting multiple clinical studies of XPOVIO® in Mainland China for the treatment of relapsed/refractory hematologic malignancies and solid tumors. Three of these studies are collaborative efforts between Antengene and Karyopharm Therapeutics Inc.

Antengene Corporation Limited is a commercial-stage biopharmaceutical company with a focus on developing and commercializing first-in-class and best-in-class therapeutics for hematologic malignancies and solid tumors. Since its inception in 2017, the company has developed a pipeline of nine oncology assets at various stages, spanning from clinical trials to commercial availability. This includes six assets with global rights and three with rights specific to the APAC region. To date, Antengene has secured 29 investigational new drug (IND) approvals across the U.S. and Asia and has submitted 10 new drug applications (NDAs) in various APAC markets. XPOVIO® (selinexor) has already been approved in Mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, and Australia.