{"id":59318,"date":"2026-03-12T11:59:44","date_gmt":"2026-03-12T03:59:44","guid":{"rendered":"https:\/\/flcube.com\/?p=59318"},"modified":"2026-03-12T11:59:45","modified_gmt":"2026-03-12T03:59:45","slug":"huadong-medicines-hdm2024-wins-fda-phase-i-approval-first-in-class-egfr-her3-bispecific-adc-targets-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59318","title":{"rendered":"Huadong Medicine’s HDM2024 Wins FDA Phase I Approval \u2013 First-in-Class EGFR\/HER3 Bispecific ADC Targets Advanced Solid Tumors"},"content":{"rendered":"\n

Huadong Medicine Co., Ltd<\/strong> (SHE: 000963<\/a>) announced that HDM2024<\/strong>, a Category 1 innovative bispecific antibody-drug conjugate (Bs-ADC)<\/strong>, has received FDA clearance<\/strong> to initiate a Phase I clinical trial<\/strong> for the treatment of advanced solid tumors<\/strong>. The first-in-class candidate<\/strong> simultaneously targets EGFR (HER1)<\/strong> and HER3<\/strong>, delivering a DNA topoisomerase I inhibitor payload<\/strong> via a cleavable linker<\/strong> to block proliferative signaling while exerting direct cytotoxic antitumor effects<\/strong>. Preclinical data demonstrate potent activity across diverse target expression levels<\/strong> with favorable druggability and safety profiles<\/strong>, positioning Huadong Medicine to enter the competitive EGFR\/HER3-targeted oncology space<\/strong> with a differentiated bispecific ADC platform<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>U.S. Food and Drug Administration (FDA)<\/td><\/tr>
Approval Type<\/strong><\/td>IND clearance \u2013 Phase I<\/td><\/tr>
Product<\/strong><\/td>HDM2024<\/td><\/tr>
Drug Class<\/strong><\/td>Bispecific antibody-drug conjugate (Bs-ADC) \u2013 Category 1 innovative biological drug<\/td><\/tr>
Targets<\/strong><\/td>EGFR (HER1) + HER3 (bispecific antibody)<\/td><\/tr>
Payload<\/strong><\/td>DNA topoisomerase I inhibitor<\/td><\/tr>
Linker<\/strong><\/td>Cleavable<\/td><\/tr>
Indication<\/strong><\/td>Advanced solid tumors<\/td><\/tr>
Developer<\/strong><\/td>Huadong Medicine Co., Ltd (SHE: 000963)<\/td><\/tr>
Approval Date<\/strong><\/td>12\u202fMar\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Mechanism<\/h2>\n\n\n\n
Attribute<\/th>HDM2024 Specification<\/th><\/tr><\/thead>
Architecture<\/strong><\/td>Bispecific antibody (anti-EGFR\/anti-HER3) + cleavable linker + topoisomerase I inhibitor payload<\/td><\/tr>
Dual Targeting<\/strong><\/td>Simultaneous EGFR and HER3 blockade<\/td><\/tr>
Mechanism of Action<\/strong><\/td>\u2022 Signal Interruption:<\/strong> Blocks EGFR\/HER3-mediated proliferative signaling
\u2022 Payload Delivery:<\/strong> Releases cytotoxic topoisomerase I inhibitor into tumor cells
\u2022 Synergistic Effect:<\/strong> Combined receptor blockade + DNA damage<\/td><\/tr>
Payload Class<\/strong><\/td>DNA topoisomerase I inhibitor (camptothecin derivative class)<\/td><\/tr>
Preclinical Activity<\/strong><\/td>Potent antitumor efficacy across various solid tumor models with different target expression levels<\/td><\/tr>
Developability<\/strong><\/td>Favorable manufacturing and safety profiles<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Scientific Rationale:<\/strong><\/p>\n\n\n\n