BGB-43395 is under clinical development by BeiGene and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase I drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how BGB-43395’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.

BGB-43395 overview

BGB-43395 is under development for the treatment of non-small cell lung cancer, solid tumors, human epidermal growth factor receptor 2 positive breast cancer, human epidermal growth factor receptor 2 negative breast cancer. It acts by targeting cyclin dependent kinases (CDK4) and human epidermal growth factor receptor 2 (HER2) and is administered as a tablet through oral route.

BeiGene overview

BeiGene is a biotechnology company. It specializes in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers BRUKINSA, a BTK (Bruton’s tyrosine kinase) inhibitor against mantle cell lymphoma (MCL). BeiGene also provides Zanubrutinib (BGB-3111), a small molecule inhibitor of BTK to treat B cell malignancies; Tislelizumab (BGB-A317), a monoclonal antibody targeting solid tumors and hematologic cancer; and Pamiparib (BGB-290) against solid tumor malignancies. The company has operations in the US, Australia, Germany, Spain, Switzerland, and Italy. BeiGene is headquartered in the Cayman Islands, the UK.

For a complete picture of BGB-43395’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 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.