Antengene’s XPO1 Inhibitor, Xpovio Receives Malaysian Regulatory Approval

Overview

Antengene Corporation Limited, 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, 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.

About Xpovio

• 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 the mainland of China, Australia, Singapore and South Korea.

ASEAN region: Potential Market

• 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.

Expanding indication for Xpovio

• 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.

Xpovio: 1st for protein XPO1

• 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.

Xpovio: Mechanism of Action

• By blocking the nuclear export protein XPO1, Xpovio can promote the intranuclear accumulation and activation of tumour 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 tumour 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 haematologic malignancies and solid tumours (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc.

Antengene Corporation Limited

Antengene Corporation Limited 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 tumours, in realizing its vision of “Treating Patients Beyond Borders.

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