Grand Pharmaceutical Announces FDA Approval of GPN00833, First Hormonal Nanoformulation in 15 Years, and IND Clearance for Myopia Drug GPN00884 in China

China Finance and Economics News, March 7th: This evening, Grand Pharmaceutical Group Limited (0512.HK) announced that the New Drug Application (NDA) for GPN00833 (APP13007), a hormone nanosuspension eye drop for post-operative anti-inflammatory and analgesic use in ophthalmology developed by its ophthalmology partner Formosa Pharmaceuticals, has been approved by the U.S. FDA. Meanwhile, the Investigational New Drug (IND) application for GPN00884, a globally innovative ophthalmic drug for delaying the progression of myopia in children, has recently been officially approved by the National Medical Products Administration.

GPN00833 is the first clobetasol propionate ophthalmic drug approved by the U.S. FDA, and also the first hormone-based nano-formulation to gain approval in 15 years. Grand Pharmaceutical Group Limited holds the exclusive development and commercialization rights for this product in mainland China, Hong Kong, and Macao. This significant overseas progress of the product will further support its registration in China.

The announcement shows that GPN00833 is a nanosuspension eye drop in the category of anti-inflammatory and analgesic hormone medications. Its main active ingredient, clobetasol propionate, is a potent glucocorticoid with highly effective localized anti-inflammatory activity and strong capillary constriction effects. Additionally, the product's unique nanoformulation technology effectively addresses the low bioavailability and safety risks caused by the poor water solubility of hormone-based products.

GPN00833 Overseas Phase II Clinical Study and Two Phase III Clinical Studies Have Successfully Reached Clinical Endpoints. Clinical Results Show That the Product Demonstrates Significant Efficacy in Post-Ophthalmic Surgery Anti-Inflammatory and Analgesic Treatment, with Good Safety. Nearly 90% of Patients Experienced No Pain at All After Surgery, and About 60% of Patients Had No Inflammatory Reaction Within 15 Days After Ophthalmic Surgery. GPN00833 Was Approved for Phase III Clinical Research in China in April 2023 and Has Completed the First Patient Dosing.

In addition, GPN00884 eye drops are an innovative drug with a novel mechanism of action for slowing the progression of myopia in children. Compared with low-concentration atropine eye drops, GPN00884 eye drops have no pupil dilation effect and will not cause adverse reactions such as photophobia or decreased accommodation. The dosing time is unrestricted, which can improve patient compliance.

This approval of GPN00884 is for a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of GPN00884 eye drops in healthy subjects after single and multiple dosing.

It is reported that in China, there is still a lack of drugs with clear efficacy and safety in delaying the progression of myopia in children, and there exists an unmet clinical need in this disease area.