Zaike Ophthalmic's innovative presbyopia treatment YUVEZZI™ has been approved for use as a clinically urgently needed imported drug at Boao Super Hospital in Hainan.

$ZHAOKE OPHTH-B (06622.HK)$ Zaike Ophthalmic Limited (“Zaike Ophthalmic” or the “Company”; HKEX Stock Code: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing, and commercialization of ophthalmic therapies to address significant unmet medical needs, is pleased to announce that on June 26, 2026, its innovative presbyopia treatment YUVEZZI™ (carbachol/brimonidine tartrate ophthalmic solution (2.75%/0.01%)) received approval from the Hainan Provincial Medical Products Administration (“Hainan MPA”) for use as a clinically urgently needed imported drug at Boao Super Hospital.

YUVEZZI™ is China’s first approved innovative drug for the treatment of presbyopia. This approval by the Hainan MPA provides an important pathway for domestic patients to gain earlier access to this innovative presbyopia therapy already available in international markets. YUVEZZI™ is a product licensed by the Company from Tenpoint Therapeutics, Ltd. (“Tenpoint”).

This approval was granted pursuant to the Decision of the State Council on Temporarily Adjusting the Implementation of Certain Provisions of the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan. Applications by medical institutions within the Pilot Zone to import small quantities of drugs (excluding vaccines) for urgent clinical needs are subject to review and approval by the Hainan Provincial People’s Government. Drugs approved for import must be used for specific medical purposes within designated medical institutions.

Dr. Xiao-Yi Li, Chairman of the Board, Executive Director, and Chief Executive Officer of Zaike Ophthalmic, stated: “We are delighted to announce that our innovative presbyopia treatment YUVEZZI™ has officially launched in Hainan, China. This important milestone not only brings an innovative therapeutic option to patients through the Hainan Pilot Zone but also marks a significant step forward in the product’s commercialization journey in China, helping accelerate the adoption of this critical therapy in one of the world’s largest ophthalmic markets. Hundreds of millions of adults in China suffer from presbyopia, and early access to high-quality treatment has the potential to meaningfully improve countless lives. We remain committed to expanding access to YUVEZZI™ in Hainan while continuing to advance clinical trials with the goal of making this innovative therapy available to patients across China as soon as possible.”

About YUVEZZI™ (carbachol/brimonidine tartrate ophthalmic solution (2.75%/0.01%))

YUVEZZI™ is a once-daily, preservative-free, room-temperature-stable miotic eye drop used to correct age-related loss of near vision. YUVEZZI™ combines fixed doses of the cholinergic agent carbachol and the alpha-2 adrenergic receptor agonist brimonidine tartrate. This novel therapy induces pupil constriction, creating a 'pinhole effect' that allows only centrally focused light to enter the eye, thereby enhancing image clarity at near and intermediate distances.

YUVEZZI™ was in-licensed by our company from its U.S. partner Tenpoint Therapeutics Ltd. ('Tenpoint'). In January 2026, Tenpoint received approval from the U.S. Food and Drug Administration (FDA) for YUVEZZI™, a once-daily dual-component eye drop, for the treatment of presbyopia—a condition characterized by a gradual loss of near vision, typically beginning around age 45. The eye drop was known as BRIMOCHOL™ PF during clinical trials and is now marketed under the brand name YUVEZZI™.

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