Utidelone is under clinical development by BioStar Pharmaceuticals and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase III drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 52% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Utidelone’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.

Utidelone overview

Utidelone is an microtubule stabilizing agent acts as an anti-neoplastic drug. It is formulated as powder for solution for intravenous route of administration. Utidelone is indicated for the treatment of recurrent or metastatic advanced breast cancer.

UTD-1 is under development for the treatment of solid tumors including head and neck cancer squamous cell carcinoma, esophageal cancer, human epidermal growth factor receptor 2 negative breast cancer (HER2- breast cancer), breast cancer brain metastasis (BCBM), human epidermal growth factor receptor 2 positive breast cancer (HER2- breast cancer), gastric cancer, pancreatic cancer, bile duct cancer (cholangiocarcinoma), ovarian cancer, non-small cell lung cancer, metastatic castration-resistant prostate cancer, breast cancer, glioblastoma multiforme, lung cancer brain metastasis and solid tumors. It is a small molecule administered intravenously, orally and in the form of nano injection. It acts as microtubule stabilizing agent. The drug candidate is an epothilone analog generated by genetic manipulation of the polyketide biosynthetic gene cluster.

It was also under development for the treatment of metastatic colorectal cancer.

BioStar Pharmaceuticals overview

BioStar Pharmaceuticals (BioStar) is a developer, manufacturer and marketer of pharmaceutical and healthcare supplement products for various diseases and conditions. The company offers products such as huangyangning tablets, hyperthyroidism capsules, danshen granule, aoxing oleanolic acid capsule, and taohuasan and tianqi dysmenorrhea capsules. Its aoxing oleanolic acid capsule is an over-the-counter medicine used for the treatment of chronic hepatitis B. BioStar’s hyperthyroidism capsules are used for the patients of hyperthyroidism with the symptoms of palpitations, sweating, irritability, dry throat, rapid pulse, and others. The company sells its products across China. BioStar is headquartered in Xianyang, China.

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

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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.