R&D Projects
Strengthening competitive positioning in drug development
LAUNXP is pursuing innovation development strategy focused on cancer drug research and development. This includes developing 505(b)(1) new chemical entity (NCE) drugs, exploring new uses for existing medications (505(b)(2)) in cancer treatment.
505(b)(1)
Develop 505(b)(1) new chemical entity (NCE) drugs.
505(b)(2)
Explore new indications for 505(b)(2) designation
The 505(b)(2) new drug development process involves modifying an existing drug’s formulation, delivery route, dosage, or approved use. This approach allows referencing existing clinical data or published literature when applying for a new drug, which can accelerate time to market, reduce development costs, and provide more treatment options to patients earlier.
Preclinical
IND
Phase I
Phase II
Phase III
NDA
Triple Negative Breast Cancer
505(b)(2)
Explore new indications for 505(b)(2) designation
The 505(b)(2) new drug development process involves modifying an existing drug’s formulation, delivery route, dosage, or approved use. This approach allows referencing existing clinical data or published literature when applying for a new drug, which can accelerate time to market, reduce development costs, and provide more treatment options to patients earlier.
