Lotus Pharmaceutical has officially submitted a New Drug Application (NDA) via the 505(b)(2) regulatory pathway to the U.S. FDA for its oncology candidate LP757 (Cabozantinib).

• Therapeutic Mechanism: Cabozantinib is an oral Tyrosine Kinase Inhibitor (TKI) that targets multiple pathways associated with tumor growth and angiogenesis (MET, VEGFR1/2/3, and AXL). It is a standard-of-care for advanced Renal Cell Carcinoma (RCC) and Hepatocellular Carcinoma (HCC).
• Market Significance: This is Lotus’s first oral oncology 505(b)(2) filing in the U.S. According to IQVIA, U.S. sales for Cabozantinib reached $1.67 billion in 2024, with the global market expected to grow to $8.4 billion by 2035 (10.9% CAGR).
• Strategic Intent: GM Petar Vazharov stated that the filing demonstrates Lotus's ability to navigate highly regulated markets with differentiated products, reinforcing its mid-to-long-term growth momentum in the global targeted therapy sector.

Resource: 美時癌症新藥送美國NDA申請 叩關百億美元市場