In-house developed innovative eye drop formulation for the treatment of rare degenerative corneal disease

Potential foundational therapy for a broad range of corneal epithelial diseases

HONG KONG, 22 October, 2021 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or “the Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of treatments that address significant unmet medical needs, is pleased to announce that the first patient was enrolled for the investigator-initiated trial (“IIT”) of one of the Company’s core products, ZKY001, for the indication of neurotrophic keratitis (“NK”) on 16 October 2021.

The main objective of the investigator-initiated trial is to evaluate the efficacy and safety of ZKY001 in the treatment of neurotrophic keratitis. The IIT trial will enroll 40 patients by the second quarter of 2022 and will be led by Professor Wu Huping from the Xiamen Eye Centre of Xiamen University as the Principal Investigator. Zhaoke Ophthalmology received approval for the use of ZKY001 in the treatment of NK from the Ethics Committee of the Xiamen Eye Centre of Xiamen University on 25 June 2021.

ZKY001 is a potential novel eye drop formulation to treat NK, a rare degenerative corneal disease. The treatment is a seven-amino acid peptide, LQ-7, that binds with actin, a type of protein that plays a central role in cell structure and movement. Zhaoke is currently conducting a Phase II clinical trial for corneal epithelial defect (“CED”).

ZKY001 has broad application in corneal wound healing and can potentially be used in multiple corneal repair indications. In addition to the ongoing Phase II clinical study for corneal epithelium repair after endothelial keratoplasty, the Company is currently exploring three additional indications for ZKY001, including transepithelial photorefractive keratectomy (surgical treatment for myopia), pterygium (an outgrowth in the cornea or conjunctiva) and NK.

NK is caused by impairment of trigeminal innervation leading to corneal epithelial breakdown, impairment of healing and development of corneal ulceration, melting and perforation. The hallmark of NK is a decrease or absence of corneal sensation. It is classified as an orphan disease with an estimated prevalence rate of 0.05%.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “ZKY001 is one of Zhaoke Ophthalmology’s flagship products, and this trial is a significant step in the development of the treatment. This drug has the potential to be a foundational therapy for a broad range of corneal epithelial diseases. Our vision is to be relentlessly patient and physician centric, so we aim to bring ZKY001 to market as soon as possible in order to offer an alternative solution of NK treatment for doctors and a more affordable option for patients who may not have access to the current expensive treatment.”