Donafenib tosylate is under clinical development by Suzhou Zelgen Biopharmaceutical and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC). According to GlobalData, Phase I drugs for Head And Neck Squamous Cell Carcinoma (HNSC) have a 79% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. 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 is a multikinase inhibitor of multiple receptor kinases. 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’s pipeline products include Donafenib Tablet, Rh Thrombin, gecacitinib hydrochloride tablets, ZG0895, ZGS15, ZG006, ZG2001, ZG1905, ZGGS001, RhTSH and gecacitinib hydrochloride Cream, ZG19018 Tablet, ZG005 Powder for Injection and ZGGS18. Its therapeutic areas include 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 10 June 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.