{"id":63204,"date":"2026-04-15T20:30:40","date_gmt":"2026-04-15T12:30:40","guid":{"rendered":"https:\/\/flcube.com\/?p=63204"},"modified":"2026-04-15T20:30:44","modified_gmt":"2026-04-15T12:30:44","slug":"shanghai-henlius-biotech-launches-phase-i-trial-for-hlx05-n-cetuximab-biosimilar-in-metastatic-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=63204","title":{"rendered":"Shanghai Henlius Biotech Launches Phase I Trial for HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer"},"content":{"rendered":"\n

Shanghai Henlius Biotech, Inc.<\/strong> (HKG: 2696<\/a>), a leading Chinese biopharmaceutical company, announced it has received regulatory approval from the National Medical Products Administration (NMPA)<\/strong> to initiate a Phase I clinical study<\/strong> for HLX05-N<\/strong>, its biosimilar candidate to Merck KGaA’s Erbitux (cetuximab)<\/strong>, in patients with metastatic colorectal cancer (mCRC)<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Shanghai Henlius Biotech, Inc. (HKG: 2696)<\/td><\/tr>
Regulatory Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Approval Type<\/strong><\/td>Clinical trial authorization<\/td><\/tr>
Study Phase<\/strong><\/td>Phase I<\/td><\/tr>
Product<\/strong><\/td>HLX05-N (cetuximab biosimilar)<\/td><\/tr>
Primary Indication<\/strong><\/td>Metastatic colorectal cancer (mCRC)<\/td><\/tr>
Additional Indications<\/strong><\/td>Squamous cell carcinoma of the head and neck<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Development Background<\/h2>\n\n\n\n

HLX05-N represents Henlius’s strategic expansion into the oncology biosimilars market. The company has already completed comprehensive pharmaceutical and non-clinical comparative studies<\/strong> that demonstrated similarity to the originator product<\/strong> (Erbitux\/cetuximab).<\/p>\n\n\n\n