Antengene Submits NDAs for XPOVIO® (Selinexor) in Multiple APAC Markets for rrMM and rrDLBCL

SHANGHAI and HONG KONG, Dec. 3, 2020 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced it has submitted new drug applications ("NDA(s)") for XPOVIO^® (selinexor, ATG-010) to the Health Sciences Authority of Singapore and to the Australian Therapeutic Goods Administration for three indications: the treatment of adult patients with relapsed or refractory multiple myeloma ("rrMM") who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody; and in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior line of therapy; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma ("rrDLBCL"), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Australian Therapeutic Goods Administration has accepted the NDA of Antengene on December 2, 2020.

A new drug application (NDA) for XPOVIO^® (selinexor) has also been submitted to the Hong Kong Department of Health for the treatment of adult patients with rrMM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

In South Korea, XPOVIO^® (selinexor) has been granted orphan drug designation for the treatment of adult patients with rrMM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody and for the treatment of adult patients with rrDLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. 

XPOVIO^® (selinexor, ATG-010) is a first-in-class and only-in-class oral selective inhibitor of nuclear export, developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA) approved XPOVIO^® (selinexor) in combination with low-dose dexamethasone for the treatment of rrMM. After its initial approval of rrMM, FDA approved XPOVIO^® (selinexor) as a single-agent for the treatment of rrDLBCL in June 2020.

In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene's partner, Karyopharm Therapeutics, presented positive results from the Phase 3 portion of the randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral XPOVIO^® (selinexor) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing phase 3 SIENDO study of XPOVIO^® (selinexor) in patients with endometrial cancer passed planned interim futility analysis and that Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

About XPOVIO^®

XPOVIO^® is a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA) approved XPOVIO^® in combination with low-dose dexamethasone for the treatment of relapsed or refractory multiple myeloma (rrMM) and in June 2020 approved XPOVIO^® as a single-agent for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). XPOVIO^® is so far the first and only oral SINE compound approved by the FDA. XPOVIO^® is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer.

Antengene is conducting two registrational Phase 2 clinical trials of XPOVIO^® in China for relapsed refractory multiple myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets, obtained 10 investigational new drug approvals and has 9 ongoing cross-regional clinical trials in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond Borders". Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

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* XPOVIO^® is a registered trademark of Karyopharm Therapeutics Inc.