January 2021
FDA IND Clearance
July 2022
NMPA IND Clearance
China's first IND clearance for 3D printed drug
Differentiation: Efficacy improvement through chronotherapy matching drug release with disease onset
Platform: 3D Microstructure for Delayed Release
March 2022
FDA IND Clearance
Differentiation: Adherence improvement through reduce dosing frequency
Platform: 3D Microstructure for Solubility Enhancement
November 2022
FDA IND Clearance
Differentiation: Safety improvement through disease site specific delivery to reduce system exposure
Platform: 3D Microstructure for Colon Targeting
January 2021
FDA IND Clearance
July 2022
NMPA IND Clearance
China's first IND clearance for 3D printed drug
Differentiation: Efficacy improvement through chronotherapy matching drug release with disease onset
Platform: 3D Microstructure for Delayed Release
March 2022
FDA IND Clearance
Differentiation: Adherence improvement through reduce dosing frequency
Platform: 3D Microstructure for Solubility Enhancement
November 2022
FDA IND Clearance
Differentiation: Safety improvement through disease site specific delivery to reduce system exposure
Platform: 3D Microstructure for Colon Targeting
RA: Rheumatoid Arthritis; PsA: Psoriatic Arthritis; AS: Ankylosing Spondylitis; AF: Atrial Fibrillation; VTE: Venous Thromboembolism; UC: Ulcerative Colitis; PAH: Pulmonary Arterial Hypertension; IgAN: IgA nephropathy
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