Luye Pharma Reports Submission of NDA to the US FDA for LY03005

Luye Pharma Reports Submission of NDA to the US FDA for LY03005

Shots:

  • The application is based on the agreement reached with the FDA under End-Of-Phase 2-CMC (EOP2-CMC) & PNDA meeting, marking the second NDA submission to the US FDA in CNS filed by Luye Pharma
  • Luye Pharma has obtained patents covering the chemical compound, crystal form, and formulation of LY03005 in the US, EU, China, Japan and Korea. Additionally, Luye Pharma has filed NDA for its LY03004 to treat schizophrenia and bipolar disorder in Mar’2019
  • LY03005 is an SNDRI & SNRI inhibitor, developed under Luye Pharma’s NCE/NTE R&D platform and has the potential to treat major depressive disorder

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