Antengene Announces NDA Submission for XPOVIO® in Indonesia

17 May 2023 | Wednesday | 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 it has submitted New Drug Applications (NDAs) for XPOVIO® (selinexor) to the Indonesia National Agency of Drug and Food Control (BPOM) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). In Q4 2022, Antengene also submitted NDAs for XPOVIO® in Malaysia and Thailand.
Image Source : Public Domain

Image Source : Public Domain

"In just six months, we have submitted NDAs for XPOVIO® in three ASEAN countries, MalaysiaThailand and Indonesia, supporting our plans to expand commercial presence in the APAC region," said Thomas Karalis, Antengene's Corporate Vice President, Head of Asia Pacific Region. "In a region characterized by countries with large populations and in many cases a lack of access to novel therapeutics, patients with R/R MM or DLBCL have urgent unmet needs for innovative, effective treatments. We hope XPOVIO® can address this unmet need and bring a new treatment option to patients with R/R MM and R/R DLBCL in these underserved markets."

"Established in China with a growing presence in the APAC region and a clear roadmap for global expansion, Antengene is striving to build up strong commercial capabilities in the ASEAN countries that has a total population exceeding 600 million and establish a global commercial infrastructure that will allow us to bring more breakthrough therapies to patients around the world," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "In the past six months, we submitted NDAs for XPOVIO® in three key ASEAN countries. This achievement is a testament to the effective execution by our teams and the company's commitment to bringing more innovative drugs to patients around the world. Moving forward, we will continue to excel in execution and maintain close contacts with the regulatory authorities of these countries for the approval of XPOVIO®."


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