Policy & Regulation
Biostar Pharma's Utidelone Injection phase two study receives US FDA approval
8 July 2024 -

Biostar Pharma, Inc., the US subsidiary of China-based Beijing Biostar Pharmaceuticals Co., Ltd., announced on Friday that has received approval from the US FDA to commence a phase two study (BG01-2402) of its core pipeline product Utidelone Injection (UTD1), intended for the treatment of HER2- breast cancer brain metastasis (BCBM).

The company says that Utidelone can penetrate the blood-brain barrier (BBB) due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux, which has been confirmed by preclinical drug tissue distribution studies and several clinical trials.

A phase 2 study of utidelone in combination with bevacizumab for the treatment of HER2- BCBM presented at the ASCO 2024, demonstrated efficacy outcomes of 42.6% of CNS-ORR, 7.7 months of mPFS, and 74.4% of 12-month OS rate with total 47 eligible patients being enrolled.

Utidelone was granted 'orphan drug designation' by the US FDA for the treatment of BCBM in March this year. Biostar then filed an IND application for this phase 2 study for HER2- BCBM. The US FDA's approval for the application is claimed to mark an important milestone in Biostar's globalisation development strategy.