Utidelone recommended by “2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer” as Class I
Utidelone recommended by “2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer” as Class I
UTD1 Phase 3 INDs approved by NMPA for NSCLC and BC neoadjuvant; UTD2 Phase 1 INDs approved by FDA and NMPA
Utidelone listed in “China's national reimbursement drug list”
Biostar Pharma, Inc. (US subsidiary) incorporated
Extraordinary general meeting held and share-holding reform completed
Utidelone Injectable NDA approval for the first indication of advanced breast cancer
Pre-IPO financing of 890 million RMB
Utidelone Injectable NDA submission as priority review
Chengdu manufacturing base established for microbial fermentation production and drug product manufacturing
Utidelone Injectable Phase 3 reached the primary endpoint
Wholly-owned subsidiary incorporated in Chengdu
R&D center established covering key biosynthesis platforms
Utidelone Injectable Phase 2/3 IND approved
Utidelone injectable Phase 1 IND approved
Beijing Biostar Pharmaceuticals incorporated in Beijing China