South Korea’s NHIS Approves Reimbursement of Antengene’s Xpovio

South Korea’s NHIS approves reimbursement of Antengene’s Xpovio to treat relapsed or refractory multiple myeloma

Overview

Antengene Corporation Limited (Antengene), a leading innovative, commercial-stage global biopharmaceutical company, announced that South Korea’s National Health Insurance Service (NHIS) has approved the reimbursement of Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM). Xpovio will be officially included into the national reimbursed drugs list of South Korea on July 1, 2024.

About MM

• MM, the second most common hematologic malignancy, is caused by the dysregulated proliferation of plasma cells. 
• Patients with MM face a range of challenges including a high relapse rate, short survival, and limited treatment options. 
• According to market data, the global MM market has exceeded US$ 17 billion in 2023 and is expected to reach US$ 26 billion by 2028, with a compound annual growth rate (CAGR) of 8.7%.

Xpovio

• With a novel mechanism of action, Xpovio is the world’s first approved orally-available, selective XPO1 inhibitor. 
• Xpovio has a global commercial presence with approvals in over 40 countries and regions.
• To date, Xpovio has already been included for health insurance coverage in mainland of China, Australia and Singapore in the APAC markets. 
• With the latest approval from the NHIS in South Korea, Xpovio is poised to be a novel treatment option and will bring clinically meaningful survival benefits to more patients in need.

NDAs for Xpovio

Antengene has already submitted NDAs for Xpovio in Thailand, Malaysia and Indonesia for the treatment of patients with R/R MM and R/R diffuse large B-cell lymphoma (R/R DLBCL).

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 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 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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