HONG KONG, 24 March 2025 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacture and commercialization of therapies that address significant unmet medical needs, today announced its annual results for the year ended 31 December 2024 (the “Reporting Period”).
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “In 2024, we made substantial strides forward in the advancements of R&D and commercialization. Critically, we have advanced the progress toward marketing approval of our three flagship innovative drug assets: NVK002 for myopia; CsA Ophthalmic Gel for dry eye disease; and TAB014 for wet age-related macular degeneration (“wAMD”). All of these accomplishments made me extremely proud. This has taken a great deal of work from our teams; and has not been easy to achieve. We are also pleased to have secured additional market approvals for our glaucoma treatments, which not only bolster our revenue position but also enhance our brand visibility with our potential customers and medical professionals. 2024 was also Zhaoke’s first full year as a joint R&D and commercial organization; furthermore we are expanding our business through partnerships across APAC which is tremendously exciting.”
R&D: Three Flagship Innovative Drugs NVK002, CsA Ophthalmic Gel, TAB014 Made Major Progress
During the Reporting Period, Zhaoke Ophthalmology advanced significantly its clinical programmes. Following the abbreviated new drug application (“ANDA”) for NVK002 (low-dose atropine 0.01%), an innovative treatment for myopia progression control in children and adolescents (submitted in early 2024); the Company received acceptance for review from the National Medical Products Administration (“NMPA”) of China in January 2025. Zhaoke also successfully completed the concurrent Phase III trial of NVK002 (“China CHAMP”) in August 2024; announcing positive topline results in October 2024. These milestones reinforce Zhaoke’s continued leadership as the second-to-market player in China’s highly competitive market.
With regard to its second flagship innovative drug; in August 2024, Zhaoke obtained regulatory approval from the NMPA to initiate an additional Phase III trial for Cyclosporine A (“CsA”) Ophthalmic Gel, a self-developed innovative drug for dry eye disease. The additional Phase III trial has been constructed in accordance with the recently updated Technical Guidelines for Clinical Trials for Dry Eyes. Zhaoke is also preparing to resubmit a new drug application (“NDA”) for CsA Ophthalmic Gel in the near future.
For the third flagship innovative drug TAB014 for wAMD, Zhaoke announced the completion of the Phase III clinical trial in September 2024, and subsequently obtained the positive topline results in January 2025. The Company is preparing to file a Biologics License Application (“BLA”) submission for TAB014 shortly after a pre-BLA discussion with the NMPA.
In addition to the three flagship drug assets, Zhaoke made notable progress with other innovative treatments. In early 2024, the Company received Investigational New Drug (“IND”) approval for BRIMOCHOLTM PF and CARBACHOLTM PF, innovative therapies for presbyopia. Patient enrolment for the Phase II clinical trials of these treatments commenced in early 2025.
Regarding the Company’s generic portfolio, Zhaoke received four additional commercialisation approvals for glaucoma treatments during the Reporting Period: Bimatoprost eye drop, Latanoprost eye drop, Travoprost eye drop, and Travoprost Timolol eye drop. Furthermore, in March 2025, the Company obtained the marketing approval for Latanoprost Timolol eye drop. Notably, the first batch of Bimatoprost eye drop (晶贝清®) was successfully delivered to patients across mainland China in November 2024. These approvals, alongside Bimatoprost Timolol eye drop (晶贝莹®), further strengthen the Company’s glaucoma portfolio and contribute positively to its revenue position.
Zhaoke now boasts a total of seven ophthalmic drugs and treatments approved for commercialisation; these seven drugs and treatments include Eyprotor, which is a treatment for corneal ulcers introduced in November 2023.
Financial Highlights: Maintaining Consistent Sales Growth, and Strong Cash Position
Zhaoke continued to experience consistent revenue growth in 2024; supported by its robust commercialization network. In 2024, the Company recorded total revenue of RMB69.3 million, representing a year-on-year increase of 268.6% compared to RMB18.8 million in 2023. Of the 2024 revenue, RMB32.6 million was generated from the sales of the key products, including the Bimatoprost Timolol eye drop (晶贝莹®), the Bimatoprost eye drop (晶贝清®) and Eyprotor; and RMB34.7 million was derived from the distribution deals with international partners.
During the year, the Company’s teams worked hard to build out Zhaoke’s sales network, and as a result, by the end of the year, Zhaoke had established relationships with of over 1,200 hospitals and eye institutions across 30 Chinese provinces, especially focusing on top tier public and private hospitals.
Turning to costs, Zhaoke maintained a prudent approach to controlling costs during the Reporting Period. The Company recorded total R&D expenses of RMB203.7 million, significantly lower than the RMB333.1 million reported in 2023. This reduction reflects the advanced stage of Zhaoke’s clinical trials for its flagship drugs. At the same time, the Company ended the year in a healthy cash position, such that, as at the end of the Reporting Period, the Company held cash and cash equivalents of RMB1.12 billion, ensuring continued support for Zhaoke’s ongoing R&D and commercialization activities.
Partnerships and Globalization Efforts Beyond China: A Core Strategic Focus
Even as awareness of ophthalmic diseases grows quickly across the Asia-Pacific region; this has not been matched by the availability of appropriate treatments and medications. This presents Zhaoke with a continuing opportunity to look for partnership opportunities and to expand its footprint beyond Greater China and into other strategic markets in the region.
The Company made significant progress during the year, in this area, and in January 2024, Zhaoke signed its second out-licensing agreement with Kwangdong Pharmaceutical Co., Ltd. (“KDP”) for the commercialization of BRIMOCHOLTM PF in South Korea. In March 2024, the Company also partnered with Pharmaniaga Logistics Sdn. Bhd. and TRB Chemedica (Thailand) Ltd., for the distribution of Bimatoprost Timolol eye drop (晶贝莹®) and EyeGiene® reusable eyemasks in Malaysia and Thailand respectively.
In addition, after the Reporting Period, in January 2025, Zhaoke entered into a distribution and supply agreement for BRIMOCHOLTM PF with AFT Pharmaceuticals Limited, a leading manufacturer and distributor of healthcare products based in New Zealand, for the commercialization of the drug in Australia and New Zealand.
While exploring opportunities with new partners, Zhaoke also strengthened its relationships with its existing strategic partners. In February 2024, Zhaoke expanded the agreement with its licensing partner for BRIMOCHOLTM PF, who recently merged with another leading organization and renamed from Visus to Tenpoint, to include new licensed territories. Zhaoke currently has the exclusive rights to develop and commercialize BRIMOCHOLTM PF and CARBACHOLTM PF in Hong Kong SAR, Macau SAR, Chinese Taipei (Taiwan), Australia, New Zealand, Saudi Arabia, the United Arab Emirates, Qatar, Bahrain, Kuwait and Oman, in addition to mainland China, South Korea and several selected ASEAN countries.
In July 2024, Zhaoke also expanded its licensing agreement with Vyluma for NVK002 to include new licensed territories; Australia, New Zealand and the Middle East, in addition to mainland China, South Korea and other countries in Southeast Asia.
Looking into 2025: Maintain the Growth Momentum with Solid Progress
Zhaoke has achieved numerous milestones in both R&D, commercialisation and the geographic expansion of its business over the past year. Looking ahead to 2025, the Company is poised to maintain solid progress, sustain stable growth momentum, and lay the groundwork for blockbuster product launches in the coming years.
Following the acceptance of the ANDA submission for NVK002 in January 2025, Zhaoke will continue to collaborate closely with regulatory authorities to expedite the drug’s market approval. Regulatory approval is expected as early as the first half of 2026.
Turning to CsA Ophthalmic Gel, the patient recruitment process for the additional Phase III clinical trial of the treatment has recently commenced. Following productive discussions with the regulatory authorities earlier this year, Zhaoke plans to resubmit the NDA for this drug in the first half of 2025.
For TAB014, after the positive results from its Phase III study were announced in January 2025, the Company intends to hold a pre-BLA meeting with the regulator in the near future, aiming to submit the BLA for TAB014 in the following months.
Additionally, Zhaoke has initiated the patient recruitment process for the Phase II clinical trials of BRIMOCHOLTM PF and CARBACHOLTM PF. The Company targets completing both Phase I and Phase II trials for these treatments within this year.
Finally, regulatory approval for the Company’s epinastine eye drops for allergic conjunctivitis (Epinastine HCl) is anticipated in the coming months.
Dr. Li concluded, “Zhaoke Ophthalmology remains steadfast in its commitment to providing the highest quality treatments to people who are suffering from eye diseases. As we look ahead to 2025, we are confident that the Company will continue to make significant strides in both R&D and commercialization, building upon our strong foundation. With a focused strategy and clear vision, we expect to achieve multiple key milestones throughout the year, setting the stage for the exciting product launches in in the next 12 to 24 months.”
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