Donafenib tosylate is under clinical development by Suzhou Zelgen Biopharmaceutical and currently in Phase II for Esophageal Cancer. According to GlobalData, Phase II drugs for Esophageal Cancer have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Donafenib tosylate’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.

Donafenib tosylate overview

Donafenib tosylate (Zepsun) is a deuterated sorafenib derivative. It is formulated as tablets for oral route of administration. Zepsun is indicated to treat patients with unresectable advanced hepatocellular carcinoma who have not received systemic treatment in the past.

Donafenib is under development for the treatment of solid tumors, endometrial cancer, advanced metastatic head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma, esophageal cancer, colorectal cancer, pancreatic cancer and cholangiocarcinoma. It is administered orally in the form of tablet. The drug candidate acts by targeting platelet-derived growth factor receptor (PDGFR) and vascular endothelial growth factor receptor (VEGFR), Raf kinase and receptor tyrosine kinases. Raf kinase and receptor tyrosine kinases regulates many pathways of cellular functions such as cell proliferation, differentiation, migration, or apoptosis. It was also under development for refractory differentiated thyroid cancer includes papillary thyroid cancer, follicular, hurthle cell thyroid cancers, esophageal cancer, acute myelocytic leukemia.

It was also under development for the treatment of relapsed acute myeloid leukemia and metastatic gastric cancer, metastatic nasopharyngeal carcinoma and recurrent head and neck squamous cell carcinoma (HNSCC).

As of 2021, Donafenib as monotherapy discontinued development for metastatic colorectal cancer.

Suzhou Zelgen Biopharmaceutical overview

Suzhou Zelgen Biopharmaceutical (Zelgen) is a pharmaceutical company that carries out research and development and production of innovative medicines. The company develops a product pipeline of small molecule new drugs and recombinant protein new drugs which covers liver cancer, non-small cell lung cancer, colorectal cancer, thyroid cancer, nasopharyngeal cancer, myeloproliferative neoplasms cancers, hematological tumors, hemorrhage, immune-inflammatory diseases, liver and gallbladder diseases and other therapeutic areas. Zelgen operates its drug research and development center in CHina and the US. Zelgen is headquartered in Kunshan, Jiangsu, China.

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

This content was updated on 20 February 2024

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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.