Antengene has announced that the Malaysian National Pharmaceutical Regulatory Agency has approved a New Drug Application (NDA) for XPOVIO (selinexor) for two indications: (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.

With a novel mechanism of action, XPOVIO is the world's first approved orally available, selective XPO1 inhibitor, which has already been approved in eight markets in APAC.

This successful approval for XPOVIO in Malaysia will introduce novel therapies to the clinical management of patients with MM in Malaysia, benefiting many patients and their families in the country. To date, XPOVIO has also been included in national health insurance or reimbursement schemes in 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.

Antengene, in efforts to fulfill its commitment to enhancing the health and well-being of the ASEAN population, has submitted NDAs for XPOVIO in Thailand and Indonesia, with approvals expected 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), T-cell non-Hodgkin's lymphoma (T-NHL), and endometrial cancer.