·        Launched first pharmaceutical product, Bimatoprost Timolol eye drop

·        Successfully concluded Phase III Mini-CHAMP for NVK002 in China for myopia progression control; Momentum built for regulatory progress

·        Positive results from Phase III clinical trial for presbyopia drug BRIMOCHOL PF in US and Europe; Obtained regulatory approvals to begin clinical trials in China

·        Completed patient recruitment for Phase III clinical trial of TAB014 targeting wAMD

·        Filed six more Abbreviated New Drug Applications for generic drugs addressing glaucoma and allergic conjunctivitis

·        Established strategic partnerships in South Korea, Malaysia and Thailand to further expand global presence

Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, today announced its annual results for the year ended 31 December 2023 (the “Reporting Period”).

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “2023 was a pivotal year for Zhaoke Ophthalmology. Not only did we recognize sales revenue for the first time, but we also made solid progress in our clinical programs. Highlights include the successful completion of the one-year Phase III clinical trial of our innovative myopia drug NVK002. We continue to be well-positioned to be second to market in China with a low-dose atropine product for myopia treatment. In addition, we began expanding beyond China by building a presence in several other Asian countries. Despite the ongoing challenging macroeconomic and geopolitical conditions, I am proud that we have remained diligently committed to our mission, successfully achieving numerous milestones across our focus areas.”

Key Developments: Drugs for Myopia, Presbyopia, Dry Eye Disease, Glaucoma, Allergic Conjunctivitis

In the Reporting Period, Zhaoke Ophthalmology made important progress across its drugs portfolio.

In February 2023, the Company’s drug for glaucoma, Bimatoprost Timolol eye drop (晶贝莹®), obtained commercialization approval from CDE. This event marked the beginning of a new chapter for Zhaoke Ophthalmology as it transformed from a pure R&D company into a commercial enterprise.

In August 2023 the Company completed its one-year Phase III clinical trial Mini-CHAMP for NVK002 addressing children myopia, in China. The drug successfully met its primary efficacy endpoint with doses of both 0.01% and 0.02%, and demonstrated strong safety and efficacy as a potential treatment for the progression of myopia in children. Regulatory momentum was also achieved with the recent submission of NDA documents to the CDE. The Company continues to position itself to be a leader in China’s low-dose atropine market.

In January 2024, the Chinese regulator granted the Company approval to begin clinical trials of its innovative candidates for presbyopia, BRIMOCHOL PF and Carbachol PF. Earlier in April 2023, the Company’s partner Visus announced positive topline results from its Phase III pivotal BRIO-I trial. An additional long-term Phase III efficacy and safety trial, BRIO-II, is currently in progress, with the results expected to be disclosed in 2024.

For Zhaoke Ophthalmology’s first in-house development innovative asset, CsA Ophthalmic Gel targeting moderate to severe dry eye disease, after comprehensive discussions with the CDE, the Company decided to retract its NDA application to allow itself sufficient time for a complete response to address the issues raised by the CDE during the review; The Company intends to refile the NDA in 2024.

The Company completed patient recruitment for its Phase III trial of TAB014 for wet age-related macular degeneration in September 2023, ahead of schedule. It also concluded several Phase II studies of ZKY001, its self-developed drug for corneal wound healing, and selected TPRK (transepithelial photorefractive keratectomy, a surgical treatment for myopia) as the focused indication for the next development stage.

Marking further progress in its efforts to tackle glaucoma, the Company filed Abbreviated New Drug Applications (ANDAs) for five of its generic drugs addressing the disease: Bimatoprost, Travoprost, Travoprost Timolol, Latanoprost and Latanoprost Timolol.   It also submitted an ANDA for its treatment for allergic conjunctivitis, Epinastine HCl, in February 2024, following the successful completion of the Phase III trial in September 2023.

Financial Highlights: First Sales Revenue, Robust Cash Position

During the Reporting Period, Zhaoke Ophthalmology recognized sales revenue for the first time, contributing to total revenue of RMB18.8 million. Of this, RMB13.2 million came from sales of the Company’s ophthalmic drugs including Bimatoprost Timolol eye drop晶贝莹® and Eyprotor, as well as its medical devices, including 堡得视® series eyepatches. Payments of RMB5.6 million were also recognized, mainly from the Company’s distribution and supply agreement for NVK002 in South Korea.

R&D expenses increased by 12.4% YoY to RMB333.1 million, reflecting the continued progress in the Company’s drugs pipeline.  These expenses are well supported by the Company’s robust cash position of RMB1.5 billion in cash and cash equivalents at the end of 2023.

Xinyan Feng (Lisa), Chief Business Officer and Chief Financial Officer of Zhaoke Ophthalmology, commented, “In 2023 we continued to exercise rigorous control over our cash expenditures, strived to optimize resource allocation, and took all prudent steps to mitigate any financial and business risks presented by the external business environment.  The tough business environment we operate in forces us to be more nimble and focused. I remain confident that with our major assets reaching regulatory approval and commercialization stages in the next couple of years, we will reach positive operating cashflow without the need to raise additional capital.”

Progress with Commercialization: Omnichannel Strategy, Partnerships and Digital Engagement

In August 2023, the Company established a strategic partnership with the Beijing-based Eyebright Medical. Zhaoke and Eyebright Medical will jointly explore opportunities to research, develop and commercialize ophthalmic products, including promoting the Company’s products in eye hospitals, ophthalmic clinics, vision centres and other traditional channels.

Zhaoke Ophthalmology also strengthened its digital engagement last year. It extended its social media reach to promote understanding of eye health issues. Meanwhile, the Company’s content-driven platform on WeChat, Zhaoke Boshi (兆科博视), continued to act as a preferred space for prominent ophthalmology KOLs to share insights and foster discussions within the broader Chinese ophthalmic community. Zhaoke Boshi now has over 15,000 followers, representing nearly half the ophthalmologist community in China.

Lisa Feng continued, “We have developed an innovative commercialization model that covers not only traditional offline channels such as hospitals and eye institutes, but also digital channels including e-commerce platforms and social media.  These allow us to promote awareness of ophthalmic disease by directly interacting with consumers. Our omnichannel approach helps enhance our brand reputation and lays a solid foundation for the future launch of our potential blockbuster drugs.”

First Steps in Globalization

Zhaoke Ophthalmology has also made the first, critical steps in developing a global presence by forming partnerships with leading pharmaceutical companies in other parts of Asia.

Dr. Li said, “Awareness of ophthalmic disease is growing rapidly, not only within China but also on a global scale. Regrettably, this growth is not matched in the availability of appropriate treatments and medications. As a result, at Zhaoke Ophthalmology we have begun establishing our global footprint to help address the unmet medical needs globally.” 

As part of this process, in March 2023, the Company reached a distribution and supply agreement with Kwangdong Pharmaceutical Co. (“KDP”), a leading Korean pharmaceutical company, for the commercialization of NVK002 in South Korea. In January 2024, Zhaoke Ophthalmology and KDP announced another distribution and supply agreement to bring its drug for presbyopia, BRIMOCHOL PF, to the Korean market. Earlier this month, the Company established partnerships with Malaysian pharmaceutical company Pharmaniaga Logistics Sdn. Bhd. and Thai biotech firm TRB Chemedica (Thailand) Ltd., for the commercialisation in their local markets of Bimatoprost Timolol eye drop 晶贝莹® and EyeGiene® reusable eyemasks, respectively. In addition, the Company continues its discussions with the U.S. Food and Drug Administration regarding an Investigational New Drug Application filing for CsA Ophthalmic Gel, as well as regulatory pathways for adjacent Asian markets.

2023 marked the beginning of a new chapter for Zhaoke Ophthalmology, proving its resilience whilst providing it with invaluable experience through program advances and commercialization activities. Looking forwards, 2024 will be a critical year for Zhaoke Ophthalmology with important milestones expected across its key focus areas.

Dr. Li continued, “Zhaoke Ophthalmology is well placed to make significant progress in 2024. We are looking forward to further developments in our R&D program across our drugs pipeline and strengthen our commercial capabilities across the whole spectrum of channels. At the same time, we are intensifying our efforts in international markets and actively reviewing strategic partnership opportunities. We are excited about the opportunities that lie ahead and are better prepared than ever to tackle the challenge of eye disease globally.”

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