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

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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


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