China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the filing of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for APP13007 (GPN00833), a modified hormone nano suspension eye drop co-developed with Taiwan-based Formosa Pharmaceuticals Inc., (TPE: 6838). The drug is in development as an ophthalmic analgesic, and this filing follows the approval to initiate a Phase III study in China last month.
APP13007’s Unique Nano Preparation Process
The active pharmaceutical ingredient (API) of APP13007 is a potent glucocorticoid, which, through a unique nano preparation process, offers efficacy and safety even at lower concentrations. Grand Pharma holds exclusive development and commercialization rights to the drug in mainland China, Hong Kong, and Macau.
Positive Clinical Study Results in the US
Phase II CPN-201 study and Phase III CPN301 and CPN-302 studies for the drug have all successfully reached their primary endpoints in the US. Summary analysis results indicate that GPN00833 demonstrates significantly better anti-inflammatory and analgesic effects compared to the control group in the treatment of cataract surgery, while also exhibiting good safety.-Fineline Info & Tech
