공고 • Jul 21
Zhaoke Ophthalmology Limited Receives Approval For Innovative Presbyopia Drug YUVEZZI Zhaoke Ophthalmology Limited announced that, on July 13, 2026, the Company’s innovative drug, YUVEZZI (carbachol 2.75% and brimonidine tartrate 0.1% ophthalmic solution), has been approved by Pharmaceutical Administration Bureau of the Government of the Macau Special Administrative Region (ISAF) for the treatment of presbyopia. The Company is proactively seeking access for YUVEZZI under the “Hong Kong-Macau Medicine and Equipment Connect” program, aiming to facilitate its early clinical use in the Greater Bay Area. YUVEZZI is a once-daily, preservative-free pupil-modulating eye drop formulation that can be stored at room temperature, designed to restore near vision lost due to presbyopia. YUVEZZI is a fixed-dose combination of carbachol, a cholinergic agent, and brimonidine tartrate, an a2-adrenergic receptor agonist. This novel therapy induces pupil constriction, creating a pinhole effect that allows only centrally focused light rays to enter the eye, thereby enhancing image sharpness at near and intermediate distances. YUVEZZI was in-licensed from the Company’s U.S. partner, Tenpoint Therapeutics Ltd. In January 2026, Tenpoint received U.S. Food and Drug Administration (FDA) approval for YUVEZZI as a once-daily, dual-agent eye drop for the treatment of presbyopia, a condition characterized by the gradual loss of close-up vision that typically begins around age 45. YUVEZZI has been approved by the Hainan Provincial Medical Products Administration for use at Boao Super Hospital as a clinically urgent imported drug in June 2026. Board Change • May 20
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Independent Non-Executive Director Fui Kiang Liew was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. 공고 • Mar 25
Zhaoke Ophthalmology Limited, Annual General Meeting, May 15, 2026 Zhaoke Ophthalmology Limited, Annual General Meeting, May 15, 2026. 공고 • Mar 11
Zhaoke Ophthalmology Limited to Report Fiscal Year 2025 Results on Mar 25, 2026 Zhaoke Ophthalmology Limited announced that they will report fiscal year 2025 results on Mar 25, 2026 공고 • Jan 14
Zhaoke Ophthalmology Limited Announces Registration Application for Atropine Sulfate Eye Drops Accepted for Evaluation by Australia's Therapeutic Goods Administration Zhaoke Ophthalmology Limited announced that, on January 5, 2026, the Company's registration application for its Atropine Sulfate Eye Drops (0.01% dose, product code: NVK002), for the treatment of myopia progression in children, has been accepted for evaluation by the Therapeutic Goods Administration (the "TGA") of Australia. The TGA has formally acknowledged that the Company's application has passed preliminary assessment and will proceed to evaluation. This application is based on positive data from the Phase III clinical trial conducted by the Company.Atropine Sulfate Eye Drops (NVK002) is an investigational novel topical ophthalmic solution to control myopia progression in children and adolescents. It has a proprietary formulation that successfully addresses the instability of low-concentration atropine, this technology has intellectual property protection globally. It is preservative-free with an expected shelf life of over 24 months. According to information from China Insights Consultancy ("CIC"), NVK002 is currently one of the most advanced atropine drug candidates globally for treating myopia progression, andtargets the broadest patient group, covering children and adolescents from 3 to 17 years old. 공고 • Nov 07
Kwangdong Pharmaceutical Co., Ltd Announces Submission of New Drug Application for Brimochol™? PF for the Treatment of Presbyopia to the MFDS in South Korea Tenpoint Therapeutics, Ltd. announced that its partner, Zhaoke Ophthalmology Ltd. has supported its South Korean partner, Kwangdong Pharmaceutical Co. Ltd. ("KDP"), in submitting a New Drug Application (NDA) for BRIMOCHOL™? PF to the Ministry of Food and Drug Safety (MFDS) in South Korea. KDP will be responsible for the manufacturing and distribution of BRIMO CHOL™? PF in South Korea. The NDA submission in South Korea was supported by positive data from the first pivotal Phase 3 BRIO-I study, which demonstrated the benefit of the combination therapy over the individual monotherapy active drug components - a requirement for approval of a fixed-dose combination. In the second vehicle-controlled Phase 3 BRIO-II study, BRIMOCHOL®? PF achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular unc incorrected near visual acuity (BUCNVA), without the loss of one line or more in binocular unc incorrected distance visual acuity (BUCDVA). In addition, BRIMOCHOL™®? PF was well-tolerated with no serious treatment-related adverse events observed in the over 70,000 treatment days monitored in the BRIO-II study. In addition to the NDA in South Korea, an NDA for BRIMOCHOL™ PF is under review in the U.S. and Tenpoint Therapeutics has received a Prescription Drug User Fee Act (PDUFA) date from the U.S. Food and Drug Administration (FDA) of January 28, 2026. 
