Company intelligence / Profile preview
Biostar Pharmaceuticals
- Ownership
- Private
- Development stage
- Commercial
Overview
Utidelone injectable, the lead product, was approved by China's NMPA in March 2021 for metastatic breast cancer after demonstrating superior efficacy over standard regimens and good safety profile in Phase III trials. The drug has been included as a Class I recommendation by the Chinese Society of Clinical Oncology guidelines and received orphan drug designation from the US FDA for both HER2-negative breast cancer brain metastasis and gastric cancer indications. Multiple expansion studies are ongoing globally including US-based trials.
- Therapeutic areas
- Oncology
- Modalities
- Small molecules (notably microtubule inhibitors via microbial fermentation)Nano-formulationsOral capsulesAntibody-drug conjugates in development
- Industry
- Biotech
Drug pipeline
2 assets1 more asset in the full pipeline.
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