US FDA Granted Biostar Pharma's IND Application to Initiate Phase 2/3 Trial of Utidelone Injectable to Treat NSCLC

US FDA Granted Biostar Pharma’s IND Application to Iiostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. announced that, after having in-depth discussions with the FDA through pre-IND meetings, the FDA has approved the IND of a phase 2/3 clinical trial with seamless protocol design for the company’s core product utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Designated as BG01-2202, this trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable (UTD1) versus docetaxel. The study is going to be conducted at about 50 sites in about 10 countries and regions across US, Europe and Asia -Pacific. About 760 patients are planned to be enrolled, 90 for phase 2 with ORR (objective response rate) as the primary endpoint and 670 for phase 3 with OS (overall survival) as the primary endpoint and PFS (progression free survival), ORR, etc.as the secondary endpoints. Dr. Li Tang, chairman of Biostar Pharma commented: “This is an important milestone for global development of utidelone injectable an innovative anti-cancer drug and new generation epothilone analogue.

We are fully committed to advancing this pivotal multi-national study and also willing to partner with global pharmaceutical companies to bring this product to market around the world to benefit more patients". Being derived from Biostar’s synthetic biology technology platform, Utidelone is a genetically engineered best-in-class epothilone analog, which is a class of microtubule-targeting agent that has differential mechanisms of action from taxanes and is developed to overcome drug resistance. Utidelone injectable has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development nitiate Phase 2/3 trial of Utidelone Injectable to Treat NSCLC.