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.

Serplulimab overview

Serplulimab (Hansizhuang) is a recombinant humanized monoclonal antibody. It is formulated as solution for intravenous route of administration. It is indicated for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments, providing an alternative treatment option for patients and squamous non-small cell lung cancer. It is also indicated in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC)

Serplulimab (HLX-10) is under development for the treatment of solid tumors including hepatocellular carcinoma, metastatic colorectal cancer, metastatic esophageal squamous cell carcinoma, extensive stage small cell lung cancer, limited stage small cell lung cancer, nasopharyngeal cancer, squamous non-small cell lung cancer, metastatic non-squamous non-small cell lung cancer, microsatellite instability high or mismatch repair deficient solid tumors, lymphoma, gastric cancers mainly adenocarcinoma, metastatic large cell neuroendocrine lung carcinoma(LCNEC). The drug candidate is a humanized monoclonal antibody which acts by targeting PD-1. It is administered through intravenous route.

Serplulimab (HLX-10) was under development for the treatment of homologous-recombination deficient (HRD) triple-negative breast cancer (TNBC), chronic hepatitis B and lymphomas, cervical cancer.

Shanghai Henlius Biotech overview

Shanghai Henlius Biotech (Henlius), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co Ltd, is a biopharmaceutical company, which includes research, development, production and marketing of monoclonal antibody products. It develops medicine for oncology, autoimmune and ophthalmic diseases. The company offers products such as 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. The company operates research and development centers in Shanghai, China and the US. Henlius is headquartered in Shanghai, China.

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

This content was updated on 2 September 2023

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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.