Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacture and commercialization of therapies that address significant unmet medical needs, is pleased to announce that it has recently obtained marketing authorizations from the National Medical Products Administration of China (“NMPA”) for three further drugs in its glaucoma franchise, and this is equivalent to passing the consistency evaluation for generic drugs.

The drugs – Latanoprost eye drop, Travoprost eye drop and Travoprost Timolol eye drop – are all manufactured by Zhaoke Ophthalmology.  Together with the Bimatoprost Timolol eye drop and the Bimatoprost eye drop, which have already received NMPA marketing approval, they comprise a comprehensive glaucoma product portfolio for intraocular pressure (“IOP”) management.  Zhaoke Ophthalmology’s goal with this suite of products is to serve a broad glaucoma patient population in China, such that physicians can choose the drugs most suited to their patients’ individual circumstances.

Glaucoma is a group of irreversible eye diseases characterized by optic atrophy and visual field loss.  Intraocular pressure-lowering drugs are recognized internationally as the first-line treatment for primary open-angle glaucoma, with prostaglandin analogs highlighted for this purpose in both the 2020 Chinese Glaucoma Guidelines (1) and the 2020 European Glaucoma Society guidelines (2).

Dr Benjamin Li, Chairman of the Board of Directors, Executive Director and Chief Executive Officer of Zhaoke Ophthalmology, said, “This latest set of regulatory approvals for our three additional generic glaucoma drugs increases the momentum behind our commercialization activities.  Our comprehensive and self-manufactured glaucoma portfolio not only offers increasing treatment choice and hope to patients; it also strengthens our brand profile in an important sector.  Building on this success, we expect further approvals in due course as we continue our mission to improve the lives of tens of millions of patients with eye disease in China and across the region.”

ABOUT LATANOPROST

Latanoprost is a prostaglandin analog (“PGA”) monotherapy eye drop that is used to treat open-angle glaucoma and ocular hypertension. According to China Insights Consultancy (“CIC”), Latanoprost is one of the most frequently prescribed PGAs for open-angle glaucoma in China.

ABOUT TRAVOPROST

Travoprost is a PGA monotherapy eye drop that is used to treat open-angle glaucoma and ocular hypertension. According to CIC, Travoprost is the most frequently prescribed PGA for open-angle glaucoma in China.

ABOUT TRAVOPROST TIMOLOL

Travoprost Timolol is a combination PGA and β-blocker eye drop to lower IOP in adult patients with open-angle glaucoma or ocular hypertension. Travoprost Timolol eye drop can be an alternative therapy for patients with open-angle glaucoma who do not achieve satisfactory intraocular pressure reduction with monotherapy. It has a dual mechanism of action, which can further lower IOP for patients who do not respond sufficiently to eye drops containing only PGAs or β-blockers.

ABOUT GLAUCOMA

According to CIC, glaucoma, the second-leading cause of blindness worldwide, is a chronic and progressive disease associated with high IOP, resulting in optic nerve damage. IOP is determined by the balance of the rate of fluid production versus fluid drainage in the eye. Generally speaking, all glaucoma cases are primary glaucoma and can be classified into two types, namely open-angle glaucoma and angle-closure glaucoma. In China, approximately 40% of the primary glaucoma cases are open-angle glaucoma.

China has the world’s largest number of glaucoma patients, accounting for approximately a quarter of all glaucoma patients worldwide. It is estimated that the number of glaucoma patients in China was 21.8 million in 2020, and 5.67 million patients will go blind (3). In addition, according to CIC, the diagnosis rate of glaucoma is expected to increase significantly from 20.0% in 2019 to 60.6% in 2030.

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(1)   Glaucoma Group of the Ophthalmology Branch of the Chinese Medical Association, Glaucoma Group of the Ophthalmology Branch of the Chinese Medical Doctor Association. Chinese Glaucoma Guidelines (2020). Chinese Journal of Ophthalmology. 2020;56(08):573-586.

(2)   European Glaucoma Society Terminology and Guidelines for Glaucoma, 5th Edition: 2020.

(3)   Quigley, A H. The number of people with glaucoma worldwide in 2010 and 2020[J]. Br J Ophthalmol, 2006, 90(3): 262-267.

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