Recently, Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK) has achieved significant progress for two global innovative ophthalmic products.
Grand Pharma’s partner in ophthalmology, Formosa Pharmaceuticals, Inc. announced that the New Drug Application (NDA) for GPN00833 (APP13007), an anti-inflammatory and analgesic hormone nanosuspension eye drops, has recently been approved by the U.S. Food and Drug Administration (FDA).
The Group has the exclusive development and commercialization rights of this product in Mainland China, Hong Kong and Macau. This significant overseas progress of this product will further support its registration in China.
The Investigational New Drug (IND) application in China of GPN00884, the Group’s globally innovative ophthalmic drug for delaying the progression of myopia in children, has been approved by the National Medical Products Administration of China (NMPA). The study is a randomized, double-blinded, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of GPN00884 eye drops after single and multiple administrations in healthy subjects.
