Cetuximab biobetter is under clinical development by Shanghai Henlius Biotech and currently in Phase II for Recurrent Head And Neck Squamous Cell Carcinoma. According to GlobalData, Phase II drugs for Recurrent Head And Neck Squamous Cell Carcinoma have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Cetuximab biobetter’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Cetuximab biobetter overview

HLX-07 is under development for the treatment of solid tumors including squamous cell carcinoma of the head and neck, squamous non-small cell lung cancer, small cell lung cancer, metastatic colorectal cancer, esophageal squamous cell carcinoma, non-squamous non-small cell lung cancer, hepatocellular carcinoma and cutaneous squamous cell carcinoma, nasopharyngeal cancer and advanced metastatic gastric cancer including gastroesophageal junction cancer. It is a humanized monoclonal antibody biobetter. It is administered through parenteral route. The drug candidate acts by targeting epidermal growth factor receptor (EGFR). It was also under development for the treatment of lung cancer.

Shanghai Henlius Biotech overview

Shanghai Henlius Biotech (Henlius), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co Ltd, is a biopharmaceutical company that develops medicine for oncology, autoimmune and ophthalmic diseases. It offers HANLIKANG, a rituximab injection, which treats non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis; HERCESSI, trastuzumab for injection for breast, metastatic breast and metastatic gastric cancer; Handayuan, Adalimumab injection, which targets rheumatoid arthritis, Ankylosing spondylitis, Psoriasis, Uveitis, Crohn’s disease and Children Crohn’s disease; Hanbetac, Bevacizumab injection, which treats metastatic Colorectal, recurrent glioblastoma, epithelial ovarian cancer and others and Hans-Shape, Slulizumab injection, for microsatellite high instability (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC). Henlius is headquartered in Shanghai, China.

For a complete picture of Cetuximab biobetter’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

Data Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.