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, Loqtorzi, Zytorvi) 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 and metastatic hepatocellular carcinoma (HCC), Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma, in combination with cisplatin and paclitaxel, is indicated for the first line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. Zytorvi in combination with cisplatin and gemcitabine, for first line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma, toripalimab as a single agent, for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.

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, Hodgkin lymphoma, B-cell non Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, upper tract urothelial carcinoma (UTUC), Muscle-invasive Urothelial Bladder Cancer, advanced differentiated thyroid cancer, papillary thyroid cancer, rectal cancer,  platinum resistant high grade serous ovarian 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), squamous non-small cell lung Cancer, and advanced or metastatic pancreatic adenocarcinoma.

Shanghai Junshi Biosciences overview

Shanghai Junshi Biosciences (Junshi Biotech) is a biopharmaceutical company that discovers, develops and commercialization of novel therapies. The company offers products for various diseases including tumor immunotherapy, autoimmune system diseases, chronic metabolic diseases, neurological diseases, and infectious diseases. Junshi Biotech products include toripalimab injection, adalimumab, Deuterated and etesevirumab. Its other pipelines drugs include JS211, JS209, JS208, JS121, JS115, JS114, JS019 and others. It works in partnership with Coherus and Conlida for the development and commercialization of its products. The company operates its research and development centers in the US and China. Junshi Biotech 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 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.