{"id":61531,"date":"2026-03-27T12:47:18","date_gmt":"2026-03-27T04:47:18","guid":{"rendered":"https:\/\/flcube.com\/?p=61531"},"modified":"2026-03-27T12:47:20","modified_gmt":"2026-03-27T04:47:20","slug":"huadong-medicines-hdm2024-wins-nmpa-approval-egfr-her3-bispecific-adc-targets-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=61531","title":{"rendered":"Huadong Medicine’s HDM2024 Wins NMPA Approval \u2013 EGFR\/HER3 Bispecific ADC Targets Advanced Solid Tumors"},"content":{"rendered":"\n

Huadong Medicine Co., Ltd.<\/strong> (SHE: 000963<\/a>) announced clinical trial approval<\/strong> from China’s National Medical Products Administration (NMPA)<\/strong> for HDM2024<\/strong>, a Category 1 biologic drug<\/strong> and novel bispecific antibody-drug conjugate (Bs-ADC)<\/strong> targeting EGFR and HER3<\/strong> for advanced solid tumor treatment<\/strong>. The approval follows earlier FDA clearance<\/strong> this month, enabling parallel China-U.S. development<\/strong> of the dual-receptor blocking ADC<\/strong> with DNA topoisomerase I inhibitor payload<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>NMPA (China) \u2013 FDA approved earlier March 2026<\/td><\/tr>
Approval Type<\/strong><\/td>Clinical trial authorization (IND)<\/td><\/tr>
Product<\/strong><\/td>HDM2024 \u2013 bispecific ADC (Bs-ADC)<\/td><\/tr>
Developer<\/strong><\/td>Huadong Medicine Co., Ltd. (SHE: 000963)<\/td><\/tr>
Drug Class<\/strong><\/td>Category 1 biologic (innovative)<\/td><\/tr>
Indication<\/strong><\/td>Advanced solid tumors<\/td><\/tr>
Dual Approval<\/strong><\/td>China + U.S. synchronized<\/strong> \u2013 global development strategy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Product Profile & Mechanism<\/h2>\n\n\n\n
Component<\/th>HDM2024 Specification<\/th>Therapeutic Function<\/th><\/tr><\/thead>
Bispecific Antibody<\/strong><\/td>Targets EGFR (HER1)<\/strong> + HER3<\/strong><\/td>Dual receptor blockade<\/strong> \u2013 inhibits tumor proliferation signaling<\/td><\/tr>
Linker<\/strong><\/td>Cleavable<\/strong> \u2013 tumor microenvironment-activated<\/td>Controlled payload release<\/td><\/tr>
Payload<\/strong><\/td>DNA topoisomerase I inhibitor<\/strong><\/td>Tumor-killing cytotoxicity<\/strong> \u2013 DNA damage-mediated cell death<\/td><\/tr>
Mechanism<\/strong><\/td>Simultaneous EGFR\/HER3 pathway inhibition + targeted toxin delivery<\/td>Signal blockade + direct cytotoxicity<\/strong> \u2013 dual anti-tumor action<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Context & Competitive Position<\/h2>\n\n\n\n
Factor<\/th>Implication<\/th><\/tr><\/thead>
EGFR\/HER3 Rationale<\/strong><\/td>EGFR<\/strong> mutated\/overexpressed in NSCLC, colorectal, head\/neck<\/strong>; HER3<\/strong> upregulated in EGFR-resistant tumors<\/strong> \u2013 dual targeting addresses acquired resistance<\/strong> and broader tumor spectrum<\/strong><\/td><\/tr>
Bispecific ADC Differentiation<\/strong><\/td>vs. patritumab deruxtecan (HER3-ADC, Daiichi)<\/strong> and cetuximab-based ADCs<\/strong> \u2013 HDM2024’s EGFR co-targeting<\/strong> may improve internalization efficiency<\/strong> and tumor selectivity<\/strong><\/td><\/tr>
Topoisomerase I Payload Trend<\/strong><\/td>DXd-derivative class<\/strong> (deruxtecan, etc.) established; HDM2024 uses similar mechanism<\/strong> with bispecific delivery advantage<\/strong><\/td><\/tr>
Huadong Biotech Expansion<\/strong><\/td>Category 1 biologic<\/strong> approval validates innovation pivot<\/strong> beyond traditional pharma distribution; ADC platform<\/strong> emerging as core capability<\/td><\/tr>
Global Development<\/strong><\/td>China-U.S. parallel trials<\/strong> enable regulatory efficiency<\/strong> and ex-China partnership potential<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n