Pucotenlimab is under clinical development by Lepu Biopharma and currently in Phase III for Non-Small Cell Lung Cancer. According to GlobalData, Phase III drugs for Non-Small Cell Lung Cancer have a 48% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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, locally advanced or metastatic gastric cancer, or metastatic non-squamous non-small cell lung cancer (NSCLC), colorectcal 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. Lepu Biopharma is headquartered in Shanghai, China.

For a complete picture of Pucotenlimab’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.