Trastuzumab biosimilar is under clinical development by Sino Biopharmaceutical and currently in Phase I for Metastatic Breast Cancer. According to GlobalData, Phase I drugs for Metastatic Breast Cancer have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Trastuzumab biosimilar’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.

Trastuzumab biosimilar overview

Trastuzumab biosimilar (Saituo) is a humanized IgG1 kappa monoclonal antibody. It is formulated as a powder for solution for the intravenous route of administration. Saituo is indicated for the treatment of HER2 (human epidermal growth factor receptor 2) positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Trastuzumab biosimilar is under development for the treatment of HER2 positive metastatic breast cancer and gastric cancer. It is administered by intravenous route. The drug candidate acts by targeting cells expressing tyrosine kinase type cell surface receptor HER2.

Sino Biopharmaceutical overview

Sino Biopharmaceutical (Sino Biopharma), a subsidiary of Charoen Pokphand Group Co Ltd, is a research-oriented pharmaceutical company that develops, manufactures, and markets medicines, biopharmaceuticals, and Chinese medicines. It offers medicines for the treatment of hepatitis, cardio-cerebral diseases, cancer, orthopedic conditions, infectious diseases and respiratory and digestive diseases, among others. The company offers products in various dosage forms including large-volume injections, PVC-free soft bags for intravenous injections, small-volume injections, powdered medicines, granulated medicines, capsules, and tablets. It works in partnership with several domestic and foreign pharmaceutical companies to advance the development of its products. Sino Biopharma is headquartered in Wanchai, Hong Kong.

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

This content was updated on 22 January 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.