HONG KONG, 28 August 2025 – 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 interim results for the six-month period ending 30 June 2025.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are thrilled to announce that the first half of 2025 has been our most fruitful period to date, with three of our core drug candidates now advancing to the New Drug Application (“NDA”) stage. We have also bolstered our visibility in several international markets while strategically expanding into new regions through partnerships. As the global capital environment improves, we see our strategic priorities validated and are excited about the growth trajectory ahead.”
Pipeline advancement: Atropine Sulfate Eye Drops, CsA Ophthalmic Gel, and Bevacizumab Intravitreal Injection are now all under NDA review
During the Reporting Period, the Company achieved significant R&D milestones for its myopia progression drug Atropine Sulphate Eye Drops (NVK002). In January 2025, the National Medical Products Administration (“NMPA”) of China accepted the Abbreviated New Drug Application (“ANDA”) for the drug at a 0.01% dosage. This was followed, in July 2025, with the NMPA also accepting the NDA for a higher 0.02% dosage. Zhaoke is currently the only company in China with two specifications of Atropine Sulphate Eye Drops undergoing regulatory review.
Zhaoke also made solid progress with its Cyclosporine A (“CsA”) Ophthalmic Gel, which targets moderate to severe dry eye disease. In April 2025, Zhaoke recruited the first patient for the additional Phase III clinical trial of CsA Ophthalmic Gel in China; and in May 2025, the NMPA accepted the resubmission of the NDA. Additionally, the U.S. Food and Drug Administration (“FDA”) approved the Investigational New Drug (“IND”) application in June 2025, allowing Zhaoke to initiate a Phase III trial for CsA Ophthalmic Gel.
For the back of the eye, its Bevacizumab Intravitreal Injection (TAB014) which targets wet age-related macular degeneration (“wAMD”), the NMPA accepted the Biological License Application (“BLA”) for this treatment in June 2025. This marks the first Bevacizumab-based antibody BLA submission for wAMD in China, positioning Zhaoke at the forefront of vision-saving therapies.
R&D: Solid progress across high-value pipeline: BRIMOCHOL™ PF, Melphalan and PAN-90806
Beyond its three near-commercial core drug candidates, Zhaoke Ophthalmology has achieved significant milestones across its robust pipeline with candidates at all stages of development, reinforcing a sustainable asset portfolio.
The Company advanced BRIMOCHOL™ PF, a once-daily, preservative-free eye drop specifically designed to address presbyopia-related near vision loss, by completing the first patient enrollment for its Phase II clinical trial in April 2025. This progress moves it closer to providing a vital solution for those affected by this condition.
In parallel, Zhaoke is making strides with its proprietary formulation of melphalan, an alkylating chemotherapeutic agent known for modifying DNA in tumor cells to disrupt replication, for the treatment of pediatric retinoblastoma (“RB”), a rare pediatric eye cancer. In July 2025, the U.S. FDA granted Orphan Drug Designation (“ODD”) to Zhaoke's melphalan, a significant step toward IND submission. If approved, this designation would grant the company seven years of U.S. market exclusivity upon NDA approval, including Market Authorization Holder (“MAH”) status and data exclusivity, effectively barring any other melphalan-based products for the retinoblastoma indication during that period. Zhaoke is focused on rapid development to leverage its potential first-mover advantage and is preparing for a pre-IND discussion with the FDA.
Further enhancing its portfolio, Zhaoke has made considerable advancements with PAN-90806, a VEGFR2 inhibitor treating wAMD and diabetic macular edema (“DME”), the leading cause of blindness among diabetics worldwide. It is a novel eye drop formulation, which decreases the number of injections required. This innovation aims to significantly reduce treatment discontinuation, and boost patient comfort, acceptance, and compliance, ultimately working to slow disease progression. Following successful outcomes from its pre-IND communication with the NMPA in June 2025, Zhaoke is now poised to submit the IND application based on an optimized formulation and a comprehensive clinical study protocol.
Lastly, Zhaoke's commitment to addressing glaucoma has seen a significant achievement as well. In March 2025, the company received marketing authorization for its Latanoprost Timolol eye drop, thereby securing approval for all six of Zhaoke’s glaucoma products. This accomplishment underscores Zhaoke’s dedication to delivering effective treatments to patients in need.
Globalisation: Enhancing visibility in current markets while expanding presence into new regions
Zhaoke is creating and pursuing global collaborations to build and enhance access to essential treatments.
AUSTRALIA & NEW ZEALAND: In January 2025, the Company established a distribution and supply agreement with AFT Pharmaceuticals Limited to market BRIMOCHOL™ PF in both Australia and New Zealand.
THAILAND: In April 2025, Zhaoke expanded its reach by partnering with Interpharma Public Company Limited to promote Atropine Sulfate Eye Drops, BRIMOCHOL™ PF, and six glaucoma medications, including Bimatoprost, Bimatoprost Timolol, Latanoprost, Latanoprost Timolol, Travoprost, and Travoprost Timolol in Thailand. Shortly thereafter, the Company joined forces with Lunatus Marketing & Consulting FZCO to facilitate the commercialization of BRIMOCHOL™ PF in the Gulf Cooperation Council (“GCC”) countries.
MIDDLE EAST: In June 2025, Zhaoke solidified a partnership with Jamjoom Pharmaceuticals Factory Company, aimed at marketing CsA Ophthalmic Gel across Saudi Arabia, the UAE, Bahrain, Kuwait, Oman, and Qatar.
INDONESIA: Its international collaboration efforts continued with an agreement in August 2025 with PT Ferron Par Pharmaceuticals to oversee the commercialization of Atropine Sulphate Eye Drops in the Indonesian market.
Zhaoke’s ophthalmic manufacturing capabilities have garnered significant global recognition throughout the industry. In June and July 2025, the Company established strategic partnerships with Somerset Therapeutics LLC, a prominent American pharmaceutical innovator, and FAREVA Group, a well-known global contract manufacturer based in France. Zhaoke’s state-of-the-art manufacturing facility in Nansha, Guangzhou, which complies with the stringent requirements of major regulatory authorities, including the NMPA, FDA, and EMA, will act as the production center for ophthalmic medications under these partnerships. These collaborations underscore the strong confidence of its international partners in Zhaoke’s commitment to excellence and innovation.
Financial Highlights: Robust finances to power future product rollout
Zhaoke reported revenue of RMB15.8 million for the first half of 2025. Excluding the one-off license income of RMB33.5 million recognized in the prior period under a product license agreement, revenue from the sale of drugs and products for the first half of 2025 amounted to RMB15.1 million, representing a slight decrease compared to RMB15.6 million for the same period in 2024. During the Reporting Period, the Company adopted a strategic shift in its sales approach, with a greater emphasis on expanding the distribution network for ophthalmic drugs, accompanied by a restructuring of the sales team to focus on key sales regions.
Zhaoke has maintained a disciplined approach to cost management. During the Reporting Period, the company recorded R&D expenses amounting to RMB113.1 million. This figure reflects the progress achieved in the clinical studies that have commenced for important drug candidates, including the additional Phase III clinical trial for CsA Ophthalmic Gel, along with the Phase II trials for BRIMOCHOL™ PF and CARBACHOL™ PF.
As of the end of June 2025, Zhaoke had RMB1,051.3 million in cash and cash equivalents, ensuring that its innovation pipeline remains well-funded. This positions Zhaoke favorably to support commercialization and future growth.
Looking forward: Aiming to have 12 commercially approved drugs by the end of 2026
Moving into the second half of 2025, Zhaoke’s primary focus on R&D will be to maintain effective communication with the regulators. The goal is to secure market approvals for Atropine Sulfate Eye Drops, both the 0.01% and 0.02% formulations, CsA Ophthalmic Gel, and Bevacizumab Intravitreal Injection as swiftly as possible.
The Company also aims to complete the Phase II clinical trial for BRIMOCHOL™ PF by the end of 2025 and continues developing its drug for corneal epithelial defects, ZKY001. Zhaoke also expects to file an IND application with the NMPA for PAN90806, an anti-VEGF novel eye drop formulation targeting wAMD, and to advance the clinical and commercial progress for melphalan in the U.S.
And finally, Zhaoke also anticipates obtaining approval of its final generic drug, Epinastine HCl eye drop, targeting allergic conjunctivitis, shortly.
Dr. Li concluded, “Looking back at the first half of the year, I am immensely proud of our team's dedication and the meaningful progress we have made. As we move into the second half, we will build upon this momentum to deliver on our promises and accelerate our growth trajectory. I am extremely excited about the year ahead, where we aim to have a total of 12 commercialized drugs by the end of 2026, significantly boosting our revenue and global brand visibility. This goal embodies our unwavering commitment to excellence in ophthalmology, supported by our passionate team and strategic initiatives, as we diligently work to enhance vision and elevate the quality of life for patients around the world.”
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