Cetuximab biobetter is under clinical development by Shanghai Henlius Biotech and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. 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, which is involved in the research, development, production, and marketing of monoclonal antibody products. It develops medicines primarily for oncology, autoimmune and ophthalmic diseases. The company’s key products include Rituximab injection for treating chronic lymphocytic leukemia and non-Hodgkin lymphoma; Trastuzumab for breast cancer, metastatic gastric cancer and metastatic breast cancer; and Adalimumab injection for ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis and uveitis. It also offers Bevacizumab Injection and Serplulimab Injection. Henlius is engaged in developing other products such as HLX14, HLX10, Serplulimab+Chemo, HLX208, HLX13 and HLX71 among others, which are under research and clinical trials. The company operates research and development centers in Shanghai, China, and California, the US. Henlius is headquartered in Shanghai, China.

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


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.