On September 23, 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 cancer, reported that the Thailand Food and Drug Administration has approved a New Drug Application (NDA) for XPOVIO (selinexor) for two indications (Press release, Antengene, SEP 23, 2024, View Source [SID1234646829]): (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma(MM) who have received at least one prior therapy; and (2) 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.
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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 markets in APAC. This successful approval for XPOVIO in Thailand will introduce novel therapies to the clinical management of patients with MM in Thailand, benefiting many patients and their families in the country. To date, XPOVIO has also been included in national health insurance or reimbursement schemes in the mainland of China, Australia, Singapore and South Korea.
The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a significant potential market for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Fulfilling its commitment to enhancing the health and well-being of the ASEAN population, Antengene has successfully obtained NDA approvals for XPOVIO in Malaysia in August and very recently in Thailand, and expects XPOVIO to be approved in Indonesia in the second half of 2024. Looking ahead, the company aims to introduce more innovative medicines to the ASEAN market, bringing improved healthcare to more patients in the region.
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]).