Antengene Announces XPOVIO® (selinexor) National Health Insurance Service Approval for Reimbursement in South Korea

- XPOVIO^® is the first XPO1 inhibitor approved for reimbursement by South Korea's National Health Insurance Service (NHIS) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM).

- The approval of XPOVIO^® by the NHIS in South Korea is the fourth national reimbursement in the Antengene markets after mainland of China, Australia and Singapore.

- Additional reimbursements of XPOVIO^® in APAC markets are expected.

- Antengene has also submitted the new drug applications (NDAs) in additional ASEAN markets, including Thailand, Malaysia and Indonesia, where approvals are expected in the H2 of 2024.

SHANGHAI and HONG KONG, June 26, 2024 /PRNewswire/ -- 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, today 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). The drug is expected to be officially included into the national reimbursed drugs list on July 1, 2024.

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%^[1].

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.

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).

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]).

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) 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 tumors, in realizing its vision of "Treating Patients Beyond Borders".

Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO^® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia.

Forward-looking statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange.

Reference:

^[1] Global Multiple Myeloma Treatment Market Size, Share & Trends Analysis Report by Treatment Type (Chemotherapy, Targeted Therapy, Immunotherapy, Stem Cell Transplantation), by Region, and Segment Forecasts, 2023-2028.

For more information, please contact:

Investor Contacts: Donald LungE-mail: Donald.Lung@antengene.com^[1]  Mobile: +86 18420672158

PR Contacts:Peter QianE-mail: Peter.Qian@antengene.com^[2] Mobile: +86 13062747000

References

1. ^{^} Donald.Lung@antengene.com (www.prnasia.com)
2. ^{^} Peter.Qian@antengene.com (www.prnasia.com)