Pucotenlimab is under clinical development by Lepu Biopharma and currently in Phase II for Head And Neck Squamous Cell Carcinoma (HNSC). According to GlobalData, Phase II drugs for Head And Neck Squamous Cell Carcinoma (HNSC) have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pucotenlimab’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.

Pucotenlimab overview

Pucotenlimab (Puyouheng) is a humanized monoclonal antagonist against human programmed cell death protein 1. It is formulated as solution for intravenous route of administration. Pucotenlimab is indicated for the treatment of patients with highly unstable microsatellite/mismatch repair deficient solid tumors, patients with advanced colorectal cancer with disease progression after prior treatment with fluorouracils, oxaliplatin, and irinotecan, disease after at least previous first-line therapy Patients with other advanced solid tumors who have progressed and have no satisfactory alternative treatment options.

Pucotenlimab is under development for the treatment of solid tumors including hepatocellular carcinoma, non-muscular invasive bladder cancer,squamous cell carcinoma of the head and neck (the “SCCHN”) and nasopharyngeal carcinoma, locally advanced or metastatic gastric cancer, metastatic melanoma, or metastatic non-squamous non-small cell lung cancer (NSCLC), metastatic colorectal cancer,  colorectal cancer, non-muscular invasive bladder cancer and gastroesophageal junction carcinomas as first line and second line. The drug candidate is administered through intravenous route and is a recombinant humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1). It is developed based on antibody analytical technology.

It was also under development for the treatment for the treatment of anaplastic thyroid cancer.

Lepu Biopharma overview

Lepu Biopharma is a biopharmaceutical company focusing on oncology therapeutics. The company is headquartered in Shanghai, China.

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

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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.