{"id":64568,"date":"2026-05-06T21:09:42","date_gmt":"2026-05-06T13:09:42","guid":{"rendered":"https:\/\/flcube.com\/?p=64568"},"modified":"2026-05-06T21:09:43","modified_gmt":"2026-05-06T13:09:43","slug":"nmpa-approves-hangzhou-biosunpharmas-bewintinib-as-first-line-jak2-inhibitor-for-myelofibrosis-with-62-8-spleen-volume-response-rate","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64568","title":{"rendered":"NMPA Approves Hangzhou Biosunpharma’s Bewintinib as First-Line JAK2 Inhibitor for Myelofibrosis with 62.8% Spleen Volume Response Rate"},"content":{"rendered":"\n

China’s National Medical Products Administration (NMPA)<\/strong> has granted approval to Hangzhou Biosunpharma Co., Ltd.<\/strong> for bewintinib<\/strong>, a novel JAK2 inhibitor<\/strong>, as first-line treatment for adult patients with intermediate-2 or high-risk myelofibrosis<\/strong>, including primary myelofibrosis (PMF), polycythemia vera\u2013related myelofibrosis (PPV-MF), and essential thrombocythemia\u2013related myelofibrosis (PET-MF).<\/p>\n\n\n\n

Regulatory Approval Details<\/h2>\n\n\n\n
Component<\/th>Specification<\/th><\/tr><\/thead>
Regulatory Authority<\/strong><\/td>National Medical Products Administration (NMPA)<\/td><\/tr>
Approval Timing<\/strong><\/td>Late April 2026<\/td><\/tr>
Indication<\/strong><\/td>First-line treatment of intermediate-2\/high-risk myelofibrosis<\/td><\/tr>
Patient Population<\/strong><\/td>Adult patients with PMF, PPV-MF, or PET-MF<\/td><\/tr>
Treatment Goals<\/strong><\/td>Address disease-related splenomegaly and improve disease-related symptoms<\/td><\/tr>
Drug Class<\/strong><\/td>JAK2 inhibitor<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

This approval marks bewintinib as the first domestically developed JAK2 inhibitor approved in China for myelofibrosis, addressing a significant unmet need in this rare hematologic malignancy.<\/p>\n\n\n\n

Clinical Trial Results \u2013 Phase II\/III Pivotal Data<\/h2>\n\n\n\n
Endpoint<\/th>Bewintinib Group<\/th>Control Group<\/th>Between-Group Difference<\/th><\/tr><\/thead>
SVR35 at 24 Weeks<\/strong><\/td>62.8%<\/strong><\/td>14.3%<\/td>+48.5 percentage points<\/strong><\/td><\/tr>
Primary Endpoint<\/strong><\/td>\u226535% reduction in spleen volume from baseline<\/td>Reference<\/td>Statistically significant<\/td><\/tr>
Safety Profile<\/strong><\/td>Manageable<\/td>–<\/td>Consistent with JAK inhibitor class<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The pivotal Phase II\/III trial demonstrated exceptional efficacy with 62.8% of patients achieving the primary endpoint of \u226535% spleen volume reduction (SVR35) after 24 weeks of treatment, representing a substantial 48.5 percentage point improvement over the control group.<\/p>\n\n\n\n

Disease Background & Unmet Need<\/h2>\n\n\n\n

Myelofibrosis Overview:<\/strong><\/p>\n\n\n\n