Beijing Biostar Pharmaceuticals Co Ltd is a China-based biopharmaceutical company specializing in the research, development, production, and commercialization of innovative oncology drugs. Founded in 2002 and headquartered in Beijing, the company develops core products including Utidelone Injection, a new-generation microtubule inhibitor produced by microbial fermentation, approved by China's NMPA in 2021 for treating metastatic breast cancer. The company’s product portfolio also includes Utidelone oral capsules, Utidelone nanoformulations, and Utidelone antibody drug conjugates, alongside other active pharmaceutical ingredients such as BG22, BG18, and BG44. These products target a broad anti-cancer spectrum including metastatic breast cancer, advanced non-small cell lung cancer, solid tumors, brain metastases of breast and lung cancers, and pancreatic cancer. The company operates primarily in the domestic Chinese market with active expansion in multinational clinical trials including in the United States.
A recent major development for Beijing Biostar is the FDA granting orphan drug designation to Utidelone for the treatment of pancreatic cancer, highlighting its expanding therapeutic applications. The company is advancing multiple clinical trials for Utidelone, including phase III studies for non-small cell lung cancer and breast cancer neoadjuvant treatment, as well as pivotal trials for brain metastases of breast and lung cancers both in China and the U.S. Beijing Biostar also announced a strategic partnership with Novotech to strengthen regional clinical trial execution capabilities. Additionally, its subsidiary US-Biostar invested in a stable income fund as part of its financial management strategy. The company’s R&D pipeline comprises one commercialized product and 19 development projects, with ongoing efforts to broaden indication approvals and develop new formulations and delivery methods. Beijing Biostar is a national high-tech enterprise driven by synthetic biology technology with significant capabilities in R&D, manufacturing, and commercialization in oncology pharmaceuticals.