{"id":40461,"date":"2025-09-01T14:19:40","date_gmt":"2025-09-01T06:19:40","guid":{"rendered":"https:\/\/flcube.com\/?p=40461"},"modified":"2025-09-01T14:19:41","modified_gmt":"2025-09-01T06:19:41","slug":"mabwell-secures-first-overseas-approval-for-denosumab-biosimilars-in-pakistan","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40461","title":{"rendered":"Mabwell Secures First Overseas Approval for Denosumab Biosimilars in Pakistan"},"content":{"rendered":"\n

China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062<\/a>)\u00a0announced that the Drug Regulatory Authority of Pakistan (DRAP) has approved its two denosumab biosimilars, 9MW0311 (Rexeva)<\/strong> and 9MW0321 (Denosu)<\/strong>. This milestone represents the first time a denosumab biosimilar has been cleared by DRAP and constitutes Mabwell\u2019s inaugural approval outside China.<\/p>\n\n\n\n

Product Overview<\/h2>\n\n\n\n
Biosimilar<\/th>Reference Product<\/th>Therapeutic Indication<\/th>Approved in China<\/th><\/tr><\/thead>
9MW0311 \u2013 Rexeva<\/strong><\/td>Prolia<\/strong> (60\u202fmg)<\/td>Osteoporosis in post\u2011menopausal women at high fracture risk<\/td>March\u202f2023<\/td><\/tr>
9MW0321 \u2013 Denosu<\/strong><\/td>XGEVA<\/strong> (120\u202fmg)<\/td>Unresectable giant cell tumor of bone (GCTB) or surgery\u2011unfeasible cases<\/td>March\u202f2024<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Denosumab, originally engineered by Amgen, is a fully human monoclonal antibody that blocks RANKL, thereby inhibiting osteoclast\u2011mediated bone resorption.<\/p>\n\n\n\n

Significance for Mabwell<\/h2>\n\n\n\n