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Antengene Receives Regulatory Approval for XPOVIO® in Hong Kong

Monday, July 17, 2023

Antengene Corporation has received approval from the Government of the Hong Kong Special Administrative Region (HKSAR) for their New Drug Application (NDA) of XPOVIO® (selinexor) in combination with dexamethasone (Xd).

This approval is specifically for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have undergone at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), and an anti-CD38 monoclonal antibody, and who have shown disease progression on the last therapy.

XPOVIO® is notable as the world's first orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a unique mechanism of action, synergistic effects in combination treatments, rapid onset of action, and long-lasting responses.

By blocking the nuclear export protein XPO1, XPOVIO® encourages the accumulation and activation of tumour suppressor proteins and growth regulating proteins within the nucleus. It also decreases the levels of multiple oncogenic proteins. The antitumor effects of XPOVIO® occur through three main pathways: 1) induction of intranuclear accumulation of tumour suppressor proteins, resulting in antitumor effects; 2) induction of intranuclear accumulation of oncogenic mRNAs, leading to a reduction in cytoplasmic levels of oncogenic proteins; and 3) activation of the glucocorticoid receptors (GR) pathway, which restores hormone sensitivity.

XPOVIO® has gained regulatory approvals in 41 countries and regions worldwide, including the United States, Israel, the United Kingdom, the European Union (27 member countries, including France and Italy), Canada, Norway, Iceland, Lichtenstein, South Korea, mainland China, Taiwan China, Hong Kong China, Singapore, Australia, and Northern Ireland.

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