Fosun Pharma’s FN-1501 Receives the US FDA’s Orphan Drug Designation for Leukemia

Fosun Pharma’s FN-1501 Receives the US FDA’s Orphan Drug Designation for Leukemia

Shots:

  • Fosun Pharma’s FN-1501 is a novel drug candidate with inhibiting FLT3 and CDK while its IND has been approved by the US FDA and NMPA in Oct & Dec 2017 respectively
  • The FDA’s ODD is granted supporting the development of drugs for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Additionally, the designation also provides various development incentives, including tax credits for qualified clinical testing, an exemption from FDA application fees, and a 7yrs. period of marketing exclusivity in the US, if approved
  • FN-1501 is currently underway for P-I to treat leukemia and solid tumors in the US, Australia, and Mainland China

Click here to­ read full press release/ article | Ref: Fosun Pharma | Image: Behance