The Board of Zhaoke Ophthalmology Limited announced that Cyclosporine A Ophthalmic Gel passed the on-site regulatory and clinical trial inspections by the National Medical Products Administration. The inspections verified the original records and information on the research and development process of CsA as well as the phase III clinical trial, which was the largest clinical trial conducted in China targeting moderate to severe dry eye disease to date. The Company also passed the Good Manufacturing Practice conducted by the Guangdong Medical Products Administration.

It confirms that the Company has put in place a GMP management framework, a core team, a complete set of analytical instruments, equipment and facilities, a well-managed documentation system and proper operations of the production and quality systems for CsA. The passing of all three inspections marks a major milestone for the Company towards the final regulatory approval and commercialization of CsA Ophthalmic Gel. In addition, the positive result of the inspections is another validation of the R&D and clinical development capabilities as well as the quality management system of the Company.

On June 8, 2022, the Company's New Drug Application of CsA Ophthalmic Gel for DED treatment was accepted for review by the Center for Drug Evaluation of the NMPA.