Antengene Announces XPOVIO® Regulatory Approval in Singapore for the Treatment of Relapsed and/or Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-cell Lymphoma in Three Indications

Mar 02, 2022View PDF

– First and Only in a unique class of XPO1 inhibitors to be approved in Singapore

– XPOVIO® Approved for Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-Cell Lymphoma

 

Shanghai and Hong Kong, PRC, March 1, 2022 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer and other life-threatening diseases, announced today that XPOVIO®(selinexor) has been granted approval from the Health Sciences Authority (HSA) in Singapore for three indications:

Relapsed or refractory multiple myeloma (R/R MM) in combination with bortezomib and dexamethasone, for treatment of adult patients with R/R MM who have received at least one prior therapy

Relapsed or refractory multiple myeloma (R/R MM) in combination with dexamethasone, for the treatment of adult patients with R/R MM 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

Relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) as monotherapy, for the treatment of adult patients with R/R DLBCL who have received at least two prior lines of treatment who are not eligible for haematopoietic cell transplant

 

Thomas Karalis, Head of APAC Markets commented: “Despite recent advances in the treatment of R/R MM and R/R DLBCL, there remains a continuing unmet need to extend survival for patients with these life-threatening diseases.  The approval of XPOVIO® presents Singapore physicians and patients with a novel addition to their existing regimens in their treatment of R/R MM and R/R DLBCL and we are very pleased to be launching XPOVIO® in Singapore and across APAC markets in the coming months.” 

 

“I am very pleased for Antengene to receive clearance from HSA and to be able to bring XPOVIO®, the first and only XPO1 inhibitor, to patients in Singapore with R/R MM and R/R DLBCL.” said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. “Receiving regulatory clearance for three important indications at the same time enables Antengene to fulfill its mission to bring first-in-class/best-in-class medicines to patients with cancer and other life-threatening diseases in APAC markets and beyond.”

 

Dr. Mei further commented “Selinexor has been evaluated in more than 10 studies and widely adopted into practice guidelines by major oncology societies around the world. Over the last few years, we have been pleased to provide selinexor to 390 patients in Asia Pacific in an early access program. Now, our commercial team is well prepared to market the product in Singapore, building upon our commercialization experience with XPOVIO® launches in China and South Korea.”

 

About the SINE Compounds

SINE (Selective Inhibitor of Nuclear Export) compounds are inhibitors of the major nuclear export protein Exportin 1 (XPO1). Currently, there are three oral SINE compounds, ATG-010 (selinexor), ATG-016 (eltanexor), and ATG-527 (verdinexor), under clinical development. Antengene has an exclusive license from Karyopharm Therapeutics Inc. (“Karyopharm”) to these compounds in certain APAC markets.

 

About XPOVIO®/ATG-010/Selinexor

Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins.  This induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.

Selinexor is approved by the US FDA for the treatment of R/R MM and R/R DLBCL.

Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021 and in Singapore for use in R/R MM and R/R DLBCL in March 2022. Antengene is conducting 10 studies in mainland China (3 in collaboration with Karyopharm) for relapsed/refractory hematological malignancies and advanced solid tumors.

 

About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for cancer and other life-threatening diseases. Driven by its vision of “Treating Patients Beyond Borders”, Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 21 investigational new drug (IND) approvals in the US and in Asia, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010/XPOVIO® in China, South Korea and Singapore approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.

 

Forward-Looking Statements

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