Antengene Announces XPOVIO®'s New Indication Included in 2024 China National Reimbursement Drug List, Making the Drug More Accessible to DLBCL Patients in the Country

SHANGHAI and HONG KONG, Nov. 28, 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 hematologic malignancies and solid tumors, today announced that the new indication of XPOVIO^® (selinexor) in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received at least two lines of systematic therapy, has been included into the 2024 China National Reimbursement Drug List (NRDL) which will officially take effect on January 1, 2025.

Following its initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM), XPOVIO^® received approval for its second indication in China in July 2024, for the treatment of patients with R/R DLBCL. To date, the two approved indications of XPOVIO^® in China have both been adopted by the NRDL, allowing a growing population of patients to benefit from the drug.

In just half a year, XPOVIO^® reached three key milestones with the new indication, from the regulatory approval, to commercial launch and inclusion into the NRDL. Such swift execution by Antengene, coupled by the strong support from China's National Healthcare Security Administration, have brought an effective, convenient and affordable innovative treatment strategy to Chinese patients with DLBCL. By bringing survival benefit to patients at ever lower financial burden on patients and their families, Antengene is making firm steps in improving the lives of cancer patients around the world.

"DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL) in adults. With an incidence rising year over year, patients with R/R DLBCL are subjected to enormous disease and financial burdens," said Prof. Jun Zhu, from Peking University affiliated Beijing Cancer Hospital. "As a novel inhibitor of the nuclear export protein, XPOVIO^® has provided Chinese patients a new treatment option that offers a unique mechanism of action (MOA), clear efficacy, and convenience of use allowing patients to receive oral treatment at home and thereby significantly reduced the cost associated with inpatient treatment. The adoption of XPOVIO^®'s indication in DLBCL by the NRDL is a great news for patients with R/R DLBCL as it will significantly improve the accessibility of this innovative drug."

With a novel mechanism of action, XPOVIO^® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in nine countries and regions in APAC, and included in the national insurance schemes in four of these markets (the mainland of China, Australia, Singapore and South Korea). Moving forward, XPOVIO^® is expected to receive public insurance coverage in more APAC markets.

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) and endometrial cancer.

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 31 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, Malaysia, Thailand and Australia.

Forward-looking statements

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