Toripalimab is under clinical development by Shanghai Junshi Bioscience and currently in Phase III for Squamous Cell Carcinoma. According to GlobalData, Phase III drugs for Squamous Cell Carcinoma have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Toripalimab’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.

Toripalimab overview

Toripalimab (Tuoyi) is a monoclonal antibody, acts as an anti-neoplastic agent. It is formulated as injectable solution for intravenous route of administration. Tuoyi is used to treat local progression or metastatic melanoma after failure of previous standard treatment. Tuoyi  is indicated for treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Toripalimab is indicated for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Tuoyi in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”). Tuoyi in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer. 

JS-001 is under development for the treatment of advanced resectable oral squamous cell carcinoma (OSCC), locally advanced anal canal squamous carcinoma, intrahepatic cholangiocarcinoma, salivary gland cancers including mucoepidermoid carcinoma, adenoid cystic carcinoma (ACC), acinic cell carcinoma, advanced thymic carcinoma, recurrent, or metastatic cervical cancer, hypopharyngeal carcinoma, soft tissue sarcoma including synovial sarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undiffertiated sarcoma, bone sarcoma, chondrosarcoma, ewing's sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, myofibroblastic sarcoma, malignant solitary fibroma, postradiation sarcoma, local advanced laryngeal, hypopharyngeal carcinoma, advanced esophageal squamous cell carcinoma, metastatic renal cell carcinoma (RCC), newly diagnosed early-stage extranodal natural killer/T cell lymphoma, advanced solid tumors including gastric cancer, metastatic colorectal cancer, ampullary carcinoma (a type of gallbladder cancer), mixed carcinoma, gallbladder cancer, such as adenocarcinoma of the gastroesophageal junction (gastric cancer), endometrial cancer, metastatic melanoma (first-line therapy), cholangiocarcinoma, metastatic breast cancer, colon cancer, small-cell lung cancer, esophageal squamous cell carcinoma, pancreatic ductal cell carcinoma, hepatocellular carcinoma, kidney cancer, urological cancers, triple-negative breast cancer, colorectal cancer, bladder urothelial carcinoma, chondrosarcoma, head and neck squamous cell carcinoma,  throat cancer, neuroendocrine carcinoma, squamous non-small cell lung Cancer non-small cell lung cancer, Hodgkin lymphoma, B-cell non Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Muscle-invasive Urothelial Bladder Cancer, advanced differentiated thyroid cancer, papillary thyroid cancer, rectal cancer and follicular thyroid cancer. It is under development for the prevention of adenomatous polyps and second primary tumors in lynch syndrome (colorectal cancer), metastatic urothelial carcinoma.

It was also under development for the treatment of epithelial ovarian cancer, metastatic castration-resistant prostate cancer, muscular-invasive bladder cancer, ureteral cancer, urethral or pelvic cancer), and advanced or metastatic pancreatic adenocarcinoma.

Shanghai Junshi Bioscience overview

Shanghai Junshi Bioscience (Junshi Bioscience) is a biopharmaceutical company that discovers, develops and commercializes drugs for infectious diseases, oncology, metabolic, auto-immunity and neurologic indications. It is investigating JS001 antibody against various malignant tumors; JS003, JS006, and JS201 to treat solid tumors; JS004 for melanoma, hodgkin lymphoma and lung carcinoma; JS101 for the treatment of breast cancer; JS108 for pancreatic, triple negative breast cancer, small cell lung cancer. The company is also evaluating JS002 against hyperlipidaemia; JS103 for hyperuricacidemia and gout disease; UPB1211 to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis arthritis; JS010 for migraine; and JS016 against COVID-19. It operates with research and development centers in California and Maryland, the US. Junshi Bioscience is headquartered in Shanghai, China.

For a complete picture of Toripalimab’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.