Pyrotinib is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Breast Cancer. According to GlobalData, Phase III drugs for Breast Cancer have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Pyrotinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

Pyrotinib overview

Pyrotinib maleate (Irene) is an anti-neoplastic agent. It is formulated as film coated tablet for oral administration. Pyrotinib maleate is indicated in combination with capecitabine for the treatment of patients with recurrent or metastatic breast cancer, who are positive for epidermal growth factor receptor 2 (HER2) and have not previously received or received trastuzumab. Patients should have received anthracycline or taxane chemotherapy before using this product.

Pyrotinib maleate (SHR-1258/HTI-1001) is under development for the treatment of HR-positive/HER2-low (IHC 2+/FISH-negative) early breast cancer, HER2-positive solid tumors like gastroesophageal junction (GEJ) adenocarcinoma, advanced or metastatic bladder urothelial cancer, triple-negative breast cancer brain metastases, gastric cancer, esophageal adenocarcinoma, colorectal cancer, solid tumor and non-small cell lung cancer. The drug candidate is administered orally. It is a tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors with Exon-20 insertion.

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

Jiangsu Hengrui Medicine overview

Jiangsu Hengrui Medicine (Jiangsu Hengrui) is a biopharmaceutical company that focuses on the research, development, manufacture, and distribution of novel pharmaceutical products. Its product portfolio includes anti-tumor drugs, surgical drugs, contrast agents, angiomyocardiac drugs, and antibiotics. The company is also developing pipeline products for the treatment of cancer, Crohn’s disease, anemia, diabetes, atopic dermatitis, chronic bone disease, blood pressure, and hypercholesterolemia. Jiangsu Hengrui has R&D facilities in China, the US, and Japan. The company offers products through its sales and distribution network in China, the US, Japan, Germany Switzerland, and Australia. Jiangsu Hengrui is headquartered in Lianyungang, Jiangsu Province, China.

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

This content was updated on 20 May 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.