{"id":49951,"date":"2025-12-04T19:18:27","date_gmt":"2025-12-04T11:18:27","guid":{"rendered":"https:\/\/flcube.com\/?p=49951"},"modified":"2025-12-04T19:18:28","modified_gmt":"2025-12-04T11:18:28","slug":"antengene-xpovio-snda-hong-kong-approval-expands-mm-dlbcl-indications","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49951","title":{"rendered":"Antengene XPOVIO sNDA Hong-Kong Approval Expands MM DLBCL Indications"},"content":{"rendered":"\n

Antengene Corporation Limited<\/strong> (HKG: 6996<\/a>) announced that Hong Kong’s Department of Health approved two supplementary New Drug Applications (sNDAs)<\/strong> for XPOVIO<\/strong> (selinexor), expanding its indications to multiple myeloma (MM)<\/strong> and relapsed\/refractory diffuse large B-cell lymphoma (R\/R DLBCL)<\/strong>.<\/p>\n\n\n\n

sNDA Approvals & New Indications<\/h2>\n\n\n\n
Indication<\/th>Regimen<\/th>Patient Population<\/th><\/tr><\/thead>
Multiple Myeloma<\/strong><\/td>XPOVIO + bortezomib + dexamethasone (XVd)<\/td>Adult patients with \u22651 prior therapy<\/td><\/tr>
R\/R DLBCL<\/strong><\/td>XPOVIO monotherapy<\/td>Adults with \u22652 prior systemic therapies, ineligible for stem cell transplantation; includes transformed follicular lymphoma<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

XPOVIO Drug Profile & Market Position<\/h2>\n\n\n\n
Attribute<\/th>Details<\/th><\/tr><\/thead>
Drug Class<\/strong><\/td>First oral Selective Inhibitor of Nuclear Export (SINE) compound<\/td><\/tr>
**Mechanism<\/td>Novel mechanism blocking nuclear export of tumor suppressor proteins<\/td><\/tr>
Asia-Pacific Approvals<\/strong><\/td>Approved in 10 countries\/regions<\/td><\/tr>
Reimbursement Coverage<\/strong><\/td>National drug lists in 5 markets: Mainland China, Taiwan, Australia, Singapore, South Korea<\/td><\/tr>
Strategic Value<\/strong><\/td>Expands Antengene’s hematology-oncology franchise in Greater China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Strategic Outlook<\/h2>\n\n\n\n