{"id":76790,"date":"2026-08-27T14:24:12","date_gmt":"2026-08-27T06:24:12","guid":{"rendered":"https:\/\/flcube.com\/?p=76790"},"modified":"2026-08-27T14:24:13","modified_gmt":"2026-08-27T06:24:13","slug":"huadong-medicines-ror1-adc-hdm2005-granted-fda-fast-track-designation-first-domestic-ror1-adc-to-achieve-the-status","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=76790","title":{"rendered":"Huadong Medicine’s ROR1 ADC HDM2005 Granted FDA Fast Track Designation \u2014 First Domestic ROR1 ADC to Achieve the Status"},"content":{"rendered":"\n

Huadong Medicine<\/strong> (SHE: 000963<\/a>) announced that its investigational drug HDM2005<\/strong> has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA)<\/strong>, making it the first domestic antibody\u2011drug conjugate (ADC) targeting receptor tyrosine kinase\u2011like orphan receptor 1 (ROR1)<\/strong> to receive Fast Track status in the United States. The designation adds to a growing regulatory track record for the asset across hematologic malignancies, including prior FDA Orphan Drug designation<\/strong> in mantle cell lymphoma and multiple combination\u2011therapy IND clearances in China.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Element<\/th>Detail<\/th><\/tr><\/thead>
Regulator<\/td>U.S. Food and Drug Administration (FDA)<\/strong><\/td><\/tr>
Designation<\/td>Fast Track<\/strong><\/td><\/tr>
Asset<\/td>HDM2005<\/strong>, anti\u2011ROR1 antibody\u2011drug conjugate (ADC)<\/td><\/tr>
Sponsor<\/td>Huadong Medicine<\/strong> (SHE: 000963)<\/td><\/tr>
Distinction<\/td>First domestic ROR1\u2011targeting ADC granted FDA Fast Track status<\/td><\/tr>
Announcement Date<\/td>27 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Regulatory Track Record \u2013 HDM2005<\/h2>\n\n\n\n
Date<\/th>Regulator<\/th>Milestone<\/th><\/tr><\/thead>
Jun 2024<\/td>NMPA & U.S. FDA<\/td>Clinical trial approval for advanced malignant solid tumors<\/td><\/tr>
Feb 2025<\/td>U.S. FDA<\/td>Orphan Drug designation<\/strong> for mantle cell lymphoma<\/td><\/tr>
May 2025<\/td>NMPA<\/td>IND approval for HDM2005 combination therapy in diffuse large B\u2011cell lymphoma (DLBCL)<\/strong><\/td><\/tr>
Jan 2026<\/td>NMPA<\/td>IND approval for combination therapy in relapsed\/refractory mantle cell lymphoma (MCL)<\/strong><\/td><\/tr>
Jun 2026<\/td>NMPA<\/td>IND approval for combination therapy in classical Hodgkin lymphoma (cHL)<\/strong><\/td><\/tr>
Aug 2026<\/td>U.S. FDA<\/td>Fast Track designation<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Development Status<\/h2>\n\n\n\n