{"id":59742,"date":"2026-03-17T18:01:10","date_gmt":"2026-03-17T10:01:10","guid":{"rendered":"https:\/\/flcube.com\/?p=59742"},"modified":"2026-03-17T18:01:11","modified_gmt":"2026-03-17T10:01:11","slug":"henlius-wins-nmpa-approval-for-hlx07-combination-trial-anti-egfr-biologic-plus-serplulimab-targets-squamous-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59742","title":{"rendered":"Henlius Wins NMPA Approval for HLX07 Combination Trial \u2013 Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC"},"content":{"rendered":"\n

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.<\/strong> (SHA: 600196<\/a>, HKG: 2196<\/a>) announced that subsidiary Shanghai Henlius Biotech, Inc.<\/strong> (HKG: 2696<\/a>) received NMPA approval<\/strong> to initiate a clinical trial evaluating HLX07 in combination with Serplulimab<\/strong> for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC)<\/strong>. The study expands Henlius’s anti-EGFR + PD-1 combination strategy<\/strong> in solid tumors, leveraging Serplulimab’s established multi-regional commercial footprint<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Approval Type<\/strong><\/td>Clinical trial authorization (IND)<\/td><\/tr>
Product<\/strong><\/td>HLX07 (anti-EGFR biologic) + Serplulimab (PD-1 inhibitor)<\/td><\/tr>
Developer<\/strong><\/td>Shanghai Henlius Biotech, Inc. (HKG: 2696), Fosun Pharma subsidiary<\/td><\/tr>
Indication<\/strong><\/td>Advanced squamous non-small cell lung cancer (sqNSCLC)<\/td><\/tr>
Study Design<\/strong><\/td>Combination therapy trial<\/td><\/tr>
Approval Date<\/strong><\/td>16\u202fMar\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Product Profiles<\/h2>\n\n\n\n

HLX07 (Anti-EGFR Biologic):<\/strong><\/p>\n\n\n\n

Attribute<\/th>Specification<\/th><\/tr><\/thead>
Target<\/strong><\/td>EGFR (epidermal growth factor receptor)<\/td><\/tr>
Format<\/strong><\/td>Innovative anti-EGFR biologic<\/td><\/tr>
Development Status<\/strong><\/td>Phase II ongoing for CSCC and sqNSCLC as monotherapy<\/td><\/tr>
Mechanism<\/strong><\/td>EGFR pathway inhibition for squamous cell carcinomas<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Serplulimab (PD-1 Inhibitor):<\/strong><\/p>\n\n\n\n

Attribute<\/th>Specification<\/th><\/tr><\/thead>
Target<\/strong><\/td>PD-1 (programmed cell death protein 1)<\/td><\/tr>
Format<\/strong><\/td>Innovative PD-1 monoclonal antibody<\/td><\/tr>
Marketing Authorization<\/strong><\/td>Approved in Mainland China, EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, India<\/strong><\/td><\/tr>
Commercial Status<\/strong><\/td>Multi-regional revenue contributor for Henlius<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Development Strategy<\/h2>\n\n\n\n
Program<\/th>Status<\/th>Indication<\/th><\/tr><\/thead>
HLX07 Monotherapy<\/strong><\/td>Phase II<\/td>Advanced cutaneous squamous cell carcinoma (CSCC)<\/td><\/tr>
HLX07 Monotherapy<\/strong><\/td>Phase II<\/td>Squamous non-small cell lung cancer (sqNSCLC)<\/td><\/tr>
HLX07 + Serplulimab<\/strong><\/td>NMPA-approved (new)<\/td>Advanced sqNSCLC (combination)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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