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Antengene Announces NDA Submission for XPOVIO® in Indonesia


SHANGHAI and HONG KONG, May 17, 2023 /PRNewswire/ 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. ....

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Antengene Announces NDA Submission for XPOVIO in Indonesia

SHANGHAI and HONG KONG, May 17, 2023 /PRNewswire/ 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. "In just six months, we have submitted NDAs for XPOVIO in three ASEAN countries, Malaysia, Thailand 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 ....

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