Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, is pleased to announce that Bimatoprost Timolol eye drop (晶贝莹®), a drug researched, developed and manufactured by Zhaoke Ophthalmology for the treatment of glaucoma, has obtained marketing authorization from the National Medical Products Administration (“NMPA”). This drug is used to lower the intraocular pressure (“IOP”) in patients with primary open-angle glaucoma or ocular hypertension who do not respond sufficiently to β-blockers or prostaglandin analogues (“PGA”).

Bimatoprost Timolol eye drop (晶贝莹®) is the first generic drug of Bimatoprost Timolol eye drop for the treatment of glaucoma/ocular hypertension in China. Manufactured on the production line that complies with Good Manufacturing Practices (“GMP”) standards, this product has already passed consistency evaluation.

Bimatoprost Timolol eye drop is a drug combination that comprises Bimatoprost and Timolol maleate. It lowers IOP by using three mechanisms, namely increasing uveoscleral and trabecular outflow of aqueous humour as well as reducing the production of aqueous humour in the ciliary body. It is more effective in lowering IOP and maintaining stable post-treatment IOP as compared with other drug combinations. Furthermore, the rate of Bimatoprost Timolol eye drop resulting in an adverse reaction, namely conjunctival hyperemia, is significantly lower than that of monotherapy or unfixed-dose combination.

The marketing authorization for Bimatoprost Timolol eye drop marks a major milestone of Zhaoke Ophthalmology in the development of drug treatment for glaucoma and begins a new chapter in the Company’s glaucoma franchise, which currently comprises of seven drugs and one  device for home-use IOP measurement.

Being the first generic drug of the Company to be authorized by the NMPA, Bimatoprost Timolol eye drop also signifies the commencement of the commercialization of the Company’s own drug pipeline.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are extremely excited to reach this historic milestone at Zhaoke Ophthalmology. The Bimatoprost Timolol eye drop is our first drug authorized by the NMPA, and marks the beginning of a new chapter for Zhaoke Ophthalmology. Glaucoma is one of the most common eye diseases globally that can cause blindness. It is estimated that the number of glaucoma patients in China was 21.8 million in 2020 and that 5.67 million patients will lose their vision. We hope to launch the Bimatoprost Timolol eye drop as quickly as possible to provide ophthalmologists and glaucoma patients with a better treatment solution. Glaucoma is a multifactorial chronic disease, and therefore Zhaoke is working on  a number of other drugs targeting different mechanisms of action as well as a home-use IOP measurement device. We will continue to address significant unmet medical needs across different  eye diseases in order to improve public visual health through scientific research as quickly as possible.”

Lisa Feng, Chief Business Officer and Chief Financial Officer of Zhaoke Ophthalmology, said, “Obtaining the marketing authorization for the Bimatoprost Timolol eye drop is a significant step for Zhaoke Ophthalmology. Although we initially embarked on the commercialization journey late last year with the launch of a medical-device grade eyepatch for dry eye on Tmall, Bimatoprost Timolol is our first in-house developed and manufactured eye drop to reach the commercial stage. The combination of our talented sales and marketing teams and their strong relationships with key hospitals and ophthalmologists, plus our state-of-the-art and fully functional manufacturing facility in Nansha, Guangzhou, mean we are ready for commercial production and sales. We believe the launch of the Bimatoprost Timolol eye drop will also lay a solid foundation for other drugs in our pipeline, including our self-developed innovative drug CsA Ophthalmic Gel, which is currently under review by the CDE.”

About Bimatoprost Timolol

Bimatoprost Timolol is a fixed-combination eye drop with Bimatoprost and β-blocker for lowering IOP. Bimatoprost, a PGA, can be used as monotherapy for primary open-angle glaucoma and ocular hypertension. Timolol is a non-selective β-adrenergic receptor blocker that can lower the IOP in primary open-angle glaucoma and angle-closure glaucoma cases.

Bimatoprost Timolol eye drops provide an alternative treatment for patients with primary open-angle glaucoma and ocular hypertension patients with poor or inadequate response to monotherapy. With three mechanisms to lower IOP, this drug can achieve target IOP in patients who have inadequate response to either PGA or β-blocker eye drops.

About Glaucoma

According to China Insights Consultancy, glaucoma, the second-leading cause of blindness worldwide, is a chronic and progressive disease associated with high IOP, resulting in optic nerve damage. The 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 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. In addition, the diagnosis rate of glaucoma is expected to increase significantly from 20.0% in 2019 to 60.6% in 2030.

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