HONG KONG, 25 March 2026 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a prominent ophthalmic pharmaceutical firm committed to advancing innovative ophthalmic therapies for critical unmet medical needs, has released its annual results for the year ending 31 December 2025.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “In 2025, Zhaoke made significant regulatory advancements across its three core assets and continued to build a global presence through partnerships with leading international pharmaceutical companies, marking one of the most successful years in its history.”

Four Key Highlights across Domestic and International R&D Achievements & Globalization Efforts

1.       Breakthrough regulatory milestones achieved across three flagship products

o   Atropine Sulfate Eye Drops (NVK002):  both 0.01% and 0.02% concentrations, are currently under regulatory review in China. The National Medical Products Administration (“NMPA”) accepted the abbreviated New Drug Application (“ANDA”) submission for the 0.01% formulation in January 2025, followed by acceptance of the NDA submission for the 0.02% formulation in July 2025.

o   CsA Ophthalmic Gel’s re-NDA submission was accepted by the NMPA in May 2025. In parallel, the U.S. Food and Drug Administration (“FDA”) granted Investigational New Drug (“IND”) clearance in June 2025 to initiate a Phase III clinical trial in the United States, demonstrating both regulatory capability and international development potential.

o   Bevacizumab Intravitreal Injection’s (TAB014) Biologics License Application (“BLA”) was accepted by the NMPA in June 2025, representing the first BLA filing in China for a bevacizumab-based antibody targeting wet age-related macular degeneration (“wAMD”).

2.       Expansion into global markets through partnerships

o   Zhaoke continued to advance its globalization strategy by expanding its presence into international markets through partnerships with leading pharmaceutical companies. These markets include the United States, Australia, New Zealand, the Middle East, South Korea, Malaysia, Thailand, Indonesia, Singapore, and Vietnam. These collaborations are strategically designed to accelerate local commercialization and broaden patient access to the Company’s ophthalmic therapies.

3.       Progress in Clinical Trials and Product Registrations in International Markets

o   United States: The FDA approved the IND application for a Phase III trial of CsA Ophthalmic Gel in June 2025. In July 2025, the Company received Orphan Drug Designation (“ODD”) for its melphalan formulation targeting pediatric retinoblastoma, reinforcing its commitment to rare pediatric eye diseases.

o   Australia: In January 2026, the Therapeutic Goods Administration (TGA) accepted the registration application for Atropine Sulfate Eye Drops (0.01%) for evaluation.

o   South Korea: Zhaoke supported its partner, Kwangdong Pharmaceutical Co., Ltd., in submitting an NDA for BRIMOCHOL™ PF, an innovative treatment for presbyopia, to the Ministry of Food and Drug Safety (“MFDS”) in November 2025.

4.       Approvals of Drug and IOP Measurement Devices Complete Our Commercial Glaucoma Product Line

o   In March 2025, Zhaoke received NMPA marketing approval for its final glaucoma generic, Latanoprost Timolol eye drops, completing the glaucoma portfolio, which includes Bimatoprost Timolol eye drops (晶贝莹®), Bimatoprost eye drops (晶贝清®), Latanoprost eye drops, Latanoprost Timolol eye drops, Travoprost eye drops, and Travoprost Timolol eye drops. Additionally, in August 2025, the Company obtained NMPA registration for TONO-i, a device for measuring intraocular pressure (“IOP”). The comprehensive glaucoma portfolio enables Zhaoke to better serve patients across China and helps physicians tailor treatments to individual needs.

Strengthened Financial Position with RMB 959 Million Cash and Cash Equivalents

For the year ending 31 December 2025, Zhaoke reported revenue of RMB 32.0 million, with drug and product sales generating RMB 30.5 million, a slight decrease from 34.6 million in 2024.

The Company has expanded its revenue generating portfolio to include Latanoprost Timolol eye drops and Epinastine Hydrochloride Eye Drops. This strategic focus on addressing market needs has resulted in a total of eight approved ophthalmic drugs.

Zhaoke has maintained a disciplined approach to cost management, with R&D expenses amounting to RMB 171.6 million. As of the end of 2025, the company held RMB 959.3 million in cash and cash equivalents, ensuring strong financial flexibility. This position allows Zhaoke to support future product launches and ongoing clinical development without sacrificing financial stability.

Zhaoke enters 2026 with significant momentum from a successful 2025, focusing on its R&D pipeline and commercialization strategies.

Dr. Li concluded, “Looking ahead to 2026, Zhaoke is entering a pivotal stage of transformation, with multiple late-stage assets approaching commercialization and a growing presence in global markets. Zhaoke remains focused on accelerating regulatory approvals, advancing clinical programs, and strengthening its commercial capabilities to capture emerging opportunities in ophthalmology. Our goal is to have 12 commercialized drugs by the end of 2026, driving revenue growth and advancing global visual health while delivering long-term value to patients and stakeholders. Zhaoke remains committed to improving patient outcomes and expanding access to innovative eye care solutions worldwide.”

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