China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that a Phase II clinical study and two Phase III clinical studies for its APP13007, a modified hormone nano suspension eye drop, have successfully reached their clinical endpoints in the United States. The clinical results demonstrate that APP13007 exhibits significant efficacy as a post-operative anti-inflammatory and analgesic, coupled with a favorable safety profile. This success paves the way for a New Drug Application (NDA) with the US FDA, which is scheduled to be filed in the first half of 2023.
Efficacy and Safety of APP13007
The active pharmaceutical ingredient (API) in APP13007 is a potent glucocorticoid, which, thanks to its unique nano formulation process，even at lower concentrations, delivers efficacy and safety. This innovation positions APP13007 as a promising candidate for post-operative care, potentially reducing inflammation and pain without compromising safety.
Exclusive Rights and Regulatory Approvals
Grand Pharma holds exclusive development and commercialization rights to APP13007 in mainland China, Hong Kong, and Macau. The company is currently awaiting regulatory decisions in China, which could further expand the drug’s market reach and impact.
The Impact of Clinical Success
The successful achievement of clinical endpoints in the US trials significantly advances APP13007 towards potential market approval and commercialization. This development is a testament to Grand Pharmaceutical Group’s commitment to innovation in pharmaceuticals and its potential to improve patient outcomes in the post-operative setting.-Fineline Info & Tech
