Pharma Focus Asia

Antengene Receives Regulatory Approval in Macau for XPOVIO® in the Treatment of Relapsed and/or Refractory Multiple Myeloma

Thursday, December 07, 2023

Antengene Corporation Limited, listed as SEHK: 6996.HK, a renowned global biopharmaceutical company specializing in innovative therapies for hematology and oncology, has obtained approval from the Pharmaceutical Administration Bureau of Macau for its New Drug Application (NDA) of XPOVIO® (selinexor). The approval is specifically for treating adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have undergone a minimum of four prior therapies and have refractory disease to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

XPOVIO® is recognized as the world's first oral selective inhibitor of the nuclear export protein XPO1, having received regulatory approvals in 42 countries and regions, including Mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, and Australia. The drug has garnered endorsement from major cancer societies and inclusion in clinical practice guidelines such as the National Cancer Care Network (NCCN) Guidelines, the Chinese Society of Clinical Oncology (CSCO) Guidelines, the European Society of Medical Oncology (ESMO) Guidelines, and the International Myeloma Working Group (IMWG) Guidelines.

Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, expressed enthusiasm about the Macau approval, marking the beginning of anticipated approvals in the Asia-Pacific (APAC) region. He highlighted the significant unmet clinical need for patients with R/R MM in the APAC region and emphasized XPOVIO® as the first and only XPO1 inhibitor approved for this purpose in Macau. Mei also mentioned ongoing efforts to expand the drug's indications in the region to provide hope to more patients and families.

Multiple myeloma (MM), characterized by the abnormal proliferation of plasma cells, is the second most common hematologic malignancy globally. Despite available treatments, MM often relapses, leading to significant challenges for patients. In China, MM ranks as the second most common hematologic malignancy, with thousands of new cases and deaths annually.

XPOVIO® works as a selective inhibitor of XPO1, offering a novel mechanism of action with synergistic effects in combination regimens. It has demonstrated fast onset of action and durable responses by promoting the intranuclear accumulation and activation of tumor suppressor proteins, down-regulating oncogenic proteins, and restoring hormone sensitivity.

The drug has received approval in various APAC markets, each with specific indications, further expanding its global presence and providing therapeutic options for patients with R/R MM and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).



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