HLX05 (cetuximab biosimilar) / Fosun Pharma, Jingze Biotech, Shanghai Henlius Biotech, Sandoz - LARVOL DELTA

Henlius and Sandoz Enter Strategic Collaboration to Unlock Global Value of Biosimilars Platform (Henlius Press Release) - "The initial assets covered under the agreement include HLX05-N, a proposed cetuximab biosimilar; HLX16, a proposed evolocumab biosimilar; and a proposed belimumab biosimilar. In addition, Sandoz has obtained an option for HLXTE-HAase1001, a recombinant human hyaluronidase. Based on these arrangements, Sandoz will pay Henlius an upfront payment, relevant milestone payments and a non-refundable option fee totaling up to US$322 million. In 2026, the total invoiced amount expected for Henlius is up to US$100.5 million....For HLX05-N, the exclusive collaboration territory covers the United States, Canada, the European Union and certain other European countries including the United Kingdom and Switzerland, Japan, Australia and New Zealand, while semi-exclusive rights apply in certain countries and regions in Asia, as well as other markets."

Licensing / partnership • Colorectal Cancer

PK equivalence: A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=387 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS

HENLIUS Receives FDA Approval for Phase 1 Clinical Trial IND for Metastatic Colorectal Cancer Treatment (iis.aastocks.com) - “HENLIUS announced that the IND application for a Phase 1 clinical trial of HLX05-N, its self-developed cetuximab injection biosimilar (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), for the treatment of mCRC, has been approved by the US Food and Drug Administration. The company plans to initiate the relevant Phase 1 clinical trial in the United States once conditions are in place.”

IND • New P1 trial • Colorectal Cancer

Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics (clinicaltrials.gov) - P1 | N=322 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Oncology

Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics (clinicaltrials.gov) - P1 | N=322 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Oncology

A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects (clinicaltrials.gov) - P1 | N=268 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date

A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects (clinicaltrials.gov) - P1 | N=268 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial