17 July 2023 | Monday | News
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 therapeutics in hematology and oncology, today announced that the Department of Health, the Government of the Hong Kong Special Administrative Region (HKSAR) has approved a New Drug Application (NDA) for XPOVIO® (selinexor), applicable in combination with dexamethasone (Xd), for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
XPOVIO® is the world's first oral selective inhibitor of the nuclear export protein (XPO1), with regulatory approvals in 41 countries and regions including the United States, Israel, the United Kingdom, the European Union (the 27 member countries including France and Italy), Canada, Norway, Iceland, Lichtenstein, South Korea, mainland of China, Taiwan China, Hong Kong China, Singapore, Australia and Northern Ireland. To date, 6 XPOVIO® regimens received a total of 27 inclusions into 7 clinical guidelines of major oncology societies in the U.S., the EU, and APAC, including 5 regimens for the treatment of myeloma and 1 regimen for the treatment of lymphoma added to the guidelines of the National Cancer Care Network (NCCN); 4 regimens for the treatment of myeloma and 1 regimen for the treatment of lymphoma added to the guidelines of the Chinese Society of Clinical Oncology (CSCO); 5 regimens for the treatment of myeloma added to the guidelines for the Diagnosis and Management of First Relapsed Multiple Myeloma in China; 4 regimens for the treatment of myeloma added to the guidelines for the Diagnosis and Management of Multiple Myeloma in China; 4 regimens for the treatment of myeloma added to the China Anti-Cancer Association's Guidelines for the Holistic lntegrative Management of Cancers (CACA); 2 regimens for the treatment of myeloma added to the guidelines of the European Society of Medical Oncology (ESMO); and 1 regimen for the treatment of myeloma added to the guidelines of the International Myeloma Working Group (IMWG).
"Antengene is very pleased to receive regulatory approval for XPOVIO® in Hong Kong. Despite recent advances in the treatment of R/R MM, there remains an unmet need to extend survival for patients with this life-threatening disease and the approval of XPOVIO® presents Hong Kong patients with access to a novel therapy in their treatment of R/R MM. We will continue to build out Antengene's presence across APAC markets and strive to expand the indications of XPOVIO® in Hong Kong and the broader APAC region, in efforts to bring renewed hope to more cancer patients." said Thomas Karalis, Antengene's Corporate Vice President, Head of Asia Pacific Region.
"I am pleased that XPOVIO® has become the first and only XPO1 inhibitor approved for the treatment of R/R MM in Hong Kong," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. Dr. Mei continued, "the Company's Named Patient Program (NPP), a growing group of investigator-sponsored studies and ongoing advisory boards have helped us to ready the path for the successful adoption of XPOVIO® in Hong Kong. Moving forward, we will establish access to ASEAN markets that have a total population exceeding 600 million. To date, Antengene has successfully submitted NDAs in Macau China, Thailand, Malaysia and Indonesia."