{"id":60606,"date":"2026-03-23T16:26:28","date_gmt":"2026-03-23T08:26:28","guid":{"rendered":"https:\/\/flcube.com\/?p=60606"},"modified":"2026-03-23T16:26:29","modified_gmt":"2026-03-23T08:26:29","slug":"henlius-biotechs-hlx18-wins-nmpa-approval-nivolumab-biosimilar-enters-phase-i-solid-tumor-trials-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=60606","title":{"rendered":"Henlius Biotech’s HLX18 Wins NMPA Approval \u2013 Nivolumab Biosimilar Enters Phase I Solid Tumor Trials in China"},"content":{"rendered":"\n

Shanghai Henlius Biotech, Inc.<\/strong> (HKG: 2696<\/a>) announced that HLX18<\/strong>, a recombinant humanized anti\u2011PD\u20111 monoclonal antibody injection<\/strong>, has received NMPA approval<\/strong> to initiate Phase I clinical trials<\/strong> for various solid tumors<\/strong> \u2013 marking dual regulatory progress for the nivolumab (Opdivo\u00ae) biosimilar<\/strong> following FDA Phase I approval in December 2025<\/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>
Product<\/strong><\/td>HLX18 \u2013 recombinant humanized anti\u2011PD\u20111 monoclonal antibody injection<\/td><\/tr>
Company<\/strong><\/td>Shanghai Henlius Biotech, Inc. (HKG: 2696)<\/td><\/tr>
Development Origin<\/strong><\/td>Independently developed by Fosun Pharma<\/strong><\/td><\/tr>
Reference Product<\/strong><\/td>Nivolumab (Opdivo\u00ae, Bristol\u2011Myers Squibb)<\/td><\/tr>
Indications<\/strong><\/td>Same as approved nivolumab indications (melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, etc.)<\/td><\/tr>
Clinical Stage<\/strong><\/td>Phase I (solid tumors)<\/td><\/tr>
Prior Approval<\/strong><\/td>FDA Phase I approval<\/strong> \u2013 December 2025<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Biosimilar Strategy & Global Development<\/h2>\n\n\n\n
Dimension<\/th>HLX18 Position<\/th>Strategic Implication<\/th><\/tr><\/thead>
Regulatory Pathway<\/strong><\/td>Dual China (NMPA) + US (FDA) Phase I approval<\/td>Harmonized development strategy; potential for global commercialization<\/td><\/tr>
Development Model<\/strong><\/td>Fosun Pharma origin; Henlius execution<\/td>Leverages Fosun’s biologics platform + Henlius’s regulatory\/commercial expertise<\/td><\/tr>
Reference Product<\/strong><\/td>Nivolumab (Opdivo) \u2013 established PD\u20111 inhibitor<\/td>Well\u2011validated target; extensive safety\/efficacy data supports biosimilar development<\/td><\/tr>
Indication Scope<\/strong><\/td>All approved nivolumab solid tumor indications<\/td>Broad addressable market; potential for extrapolation strategy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Competitive Positioning<\/h2>\n\n\n\n
Dimension<\/th>PD\u20111 Inhibitor Landscape<\/th>HLX18 Position<\/th><\/tr><\/thead>
Originator Market<\/strong><\/td>Opdivo (BMS) + Keytruda (Merck) dominate US$35+ billion<\/strong> global PD\u20111\/PD\u2011L1 market<\/td>Biosimilar entry anticipated 2027\u20112028 (nivolumab EU patent expiry 2028; US 2031)<\/td><\/tr>
China Biosimilar Competition<\/strong><\/td>10+ domestic PD\u20111 inhibitors approved; intense price competition (annual therapy <RMB30,000)<\/td>HLX18 adds to crowded field; differentiation via global regulatory credibility<\/strong> (FDA approval)<\/td><\/tr>
Fosun\/Henlius Synergy<\/strong><\/td>Fosun Pharma origin + Henlius commercialization<\/td>Integrated development\u2011to\u2011market pathway; potential cost advantages<\/td><\/tr>
Ex\u2011China Opportunity<\/strong><\/td>FDA approval enables US clinical development; EU pathway possible<\/td>Global biosimilar market access vs. China\u2011only competitors<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Impact & Outlook<\/h2>\n\n\n\n