Antengene Corporation Limited, 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 it has submitted New Drug Applications (NDAs) for XPOVIO® (selinexor) to the Pharmaceutical Administration Bureau of Macau, Malaysian National Pharmaceutical Regulatory Agency and Thai Food and Drug Authority for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). The Company also plans to submit an NDA for XPOVIO® in Indonesia in the first half of 2023.
“Filing these NDAs in Macau, Malaysia and Thailand is an important step in the next wave of geographic expansion for XPOVIO® and Antengene,”said Thomas Karalis, Antengene’s Corporate Vice President, Head of Asia Pacific Region. “With limited access to novel agents in these markets and with large populations, a high unmet medical need exists in management of both patients with MM and DLBCL. When approved, XPOVIO® will offer an important novel treatment option in the care of patients with these life threatening diseases in Macau, Malaysia and Thailand.”
“Antengene is executing on our strategy to bring transformative medicines to patients around the world. The APAC/ ASEAN markets are an important cornerstone of our commercial strategy and so we are very pleased to complete the NDA filings for XPOVIO® in Macau, Malaysia and Thailand,” said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. “Based on our robust clinical data package and positive commercial experience to date, we feel that, if approved in these markets, we will be well prepared to effect a successful launch of XPOVIO® in order to support patient uptake and enable improved outcomes for patients with R/R MM and R/R DLBCL. We look forward to working with each regulatory agency as the reviews progress.”