Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company, is delighted to announce that the National Medical Products Administration (“NMPA”) of China has recently accepted the New Drug Application (“NDA”) for one of the Company’s core products, Cyclosporine (“CsA”) Ophthalmic Gel, a self-developed innovative drug.

Through comprehensive communication and a pre-NDA discussion for CsA Ophthalmic Gel with the NMPA, the Company has received a written reply from the NMPA endorsing the NDA, which is based on the results from the previously completed Phase III clinical trial (COSMO study) as well as further data mining and post-hoc analysis on this clinical trial.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “We are thrilled to announce the successful NDA submission of our self-developed CsA Ophthalmic Gel in China. This milestone reflects our unwavering commitment to ophthalmic innovation and potentially addresses a critical unmet need for dry eye patients. As a leading ophthalmic drug developer, we take great pride in advancing cutting-edge therapies that improve lives. Looking ahead, we remain steadfast in our mission to deliver transformative treatments for eye diseases, empowering patients in China and globally to achieve better visual health and quality of life.”

About CsA Ophthalmic Gel

CsA Ophthalmic Gel is an innovative cyclosporine gel developed by the company in China to treat moderate to severe dry eye disease (“DED”). Unlike Restasis®, emulsion formulation, CsA Ophthalmic Gel is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles and exposure of CsA on the ocular surface, giving CsA more time to exert its effect on DED.

The previous phase II study results suggested that 0.05% CsA Ophthalmic Gel (q.d.), applied once daily at night, had efficacy and safety profiles at least like those of Restasis® (0.05% CsA, b.i.d.), which is used twice daily. This eliminates the need for daytime administration and the associated discomfort and inconvenience. In addition, the results of the previous phase III study (COSMO) conducted by the Company indicate that the onset of action for CsA Ophthalmic Gel can start in as early as two weeks. As a result of once daily application and a rapid onset of action, the Company expects its CsA Ophthalmic Gel to improve patients’ compliance and quality of life significantly.

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