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 interim results for the six months ended 30 June 2024 (the “Reporting Period”).

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “Over the first half of this year, Zhaoke Ophthalmology made solid progress across our various R&D programs, and at the same time saw encouraging sales growth in our commercialized portfolio. We also expanded our footprint in the strategically important Southeast Asia market to further monetize the value of our core product portfolio.”

Critical R&D Progress: NVK002, CsA Ophthalmic Gel, BRIMOCHOL PF/CARBACHOL PF, Glaucoma Franchise

During the Reporting Period, Zhaoke Ophthalmology marked several important milestones in the development of its key drugs.

In particular, the Company successfully progressed the regulatory process for NVK002, the Company’s treatment for myopia progression control in adolescents and children. Following the conclusion in 2023 of its one-year Phase III clinical trial (“Mini-CHAMP”), Zhaoke Ophthalmology submitted an Abbreviated New Drug Application (“ANDA”) to the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) earlier this year. The Company is now preparing supplementary material according to the requirements of the CDE.  Earlier this month, the two-year Phase III clinical trial of NVK002 (“China CHAMP”) completed the last-patient-last-visit. The Company expects to announce topline results from this pivotal study in due course.

While competition in the atropine market in China is growing, Zhaoke Ophthalmology continues to be well-positioned to provide the second low-dose atropine product to market, and so help improve the quality of life for the hundreds of millions of children in China who suffer from myopia.

In August 2024, the Company announced that it had received Investigational New Drug (“IND”) approval from the NMPA for an additional Phase III clinical trial of CsA Ophthalmic Gel, an innovative drug the Company is developing to treat dry-eye disease. This new trial has been designed to closely follow the latest requirements outlined by the regulator. The Company is conducting further data mining and post-hoc analysis on the previously completed Phase III clinical trial (“COSMO”). The company plans to file an application for a pre-NDA discussion with the CDE regarding the post-hoc analysis data, and will re-file an NDA submission in the near future.

In January 2024, Zhaoke obtained IND approval to begin Phase I and Phase II clinical trials of BRIMOCHOL PF and CARBACHOL PF, an innovative treatment for presbyopia. The Company has already started the Phase II trial and is ready to begin the Phase I trial.

The Company has been progressing as planned with the Phase III clinical trial of TAB014, the bevacizumab-based antibody indicated for wet age-related macular degeneration in China. By the end of August 2024, over 90% of enrolled patients will have finished dosage. The Company expects to complete the Phase III trial in the near future.

Zhaoke has previously submitted the ANDAs for five of its generic drugs addressing glaucoma: Bimatoprost, Travoprost, Travoprost Timolol, Latanoprost and Latanoprost Timolol. During the reporting period, the Company has received requests for supplementary materials from the CDE for all these drugs and will submit supplementary documents accordingly.

Financial Highlights: Encouraging Sales Growth, and Strong Cash Position

Zhaoke Ophthalmology is now a joint research and commercial enterprise. In the first six months of 2024, Zhaoke saw a significant increase in revenue, recording RMB49.8 million,

This growth was driven by growing sales of the Company's ophthalmic drug portfolio, including Bimatoprost Timolol eye drops (晶贝莹®, a drug addressing glaucoma) and Eyprotor (a treatment for corneal ulcers), which generated RMB13.6 million, up from RMB2.3 million a year earlier. The company also recorded RMB2.1 million from sales of its 堡得视® eye patches. Additionally, Zhaoke recognized RMB34.1 million in revenue from out-licensing deals for Adapalene and Clindamycin Gel (an acne treatment drug) to Lee's Pharm, and BRIMOCHOL PF (a treatment for presbyopia) to South Korea.

This growth in sales of Zhaoke’s ophthalmic drugs is attributable to the enrichment of the Company’s product offerings, as well as to its efforts to advance hospital listings and strengthen its coverage of top eye hospitals in China. This has established a robust foundation to facilitate the future commercial launch and market adoption of the Company's glaucoma portfolio and innovative drug pipeline.

Given the number of innovative drugs already in the Company’s pipeline and at an advanced clinical stage, Zhaoke continued to adopt a prudent approach to cost control, and prioritize resource allocation towards late-stage drug candidates. The Company’s R&D expenses were approximately RMB89.8 million in the first six months of 2024, compared to approximately RMB205 million for the same period in 2023.

As of 30 June 2024, Zhaoke had a cash balance of approximately RMB1.3 billion, providing ample resources to complete its key R&D programs and achieve positive cash flow. Leveraging this strong financial position, the Company is well-equipped to sustain its continued healthy development.

Globalization: A Core Strategic Focus

The sales potential for Zhaoke’s portfolio is international, and in the first half of 2024 the Company grew its overseas footprint with several notable partnerships, in particular in the critical Southeast Asia market.

In January 2024, Zhaoke increased its presence in Korea by deepening its relationship with leading Korean firm Kwangdong Pharmaceutical Co., Ltd.  to include a distribution and supply agreement for BRIMOCHOL PF as well as NVK002.

In March 2024, the Company established a partnership with Malaysian pharmaceutical company Pharmaniaga Logistics Sdn. Bhd. for the commercialization of Bimatoprost Timolol eye drop (晶贝莹®).  It also partnered with Thai biotech firm TRB Chemedica (Thailand) Ltd. for EyeGiene® reusable eyemasks.

Zhaoke continues to explore additional partnership opportunities outside China as its international strategy accelerates, most notably in Southeast Asia, South Korea, the U.S. and Australia. The Company is continuing its engagement with the U.S. Food and Drug Administration for the potential clinical trial and commercialization of CsA Ophthalmic Gel in North America, with an IND application targeted for the end of 2024.

Second Half of 2024: A Number of Important Milestones to Expect

Over the rest of this year, Zhaoke Ophthalmology expects to build on the solid R&D progress it made during the first half of 2024.  In particular, the Company will maintain close communication with the regulators regarding the approval processes for NVK002 and CsA Ophthalmic Gel, aiming to secure NDA acceptance and set the stage for marketing approvals as quickly as possible. Zhaoke also anticipates completing the Phase III clinical trial of TAB014 and making an NDA submission shortly afterwards. 

In addition to progress with its proprietary drugs, Zhaoke also expects to begin receiving regulatory approvals for several assets in its generic portfolio, including the drugs targeting glaucoma, and Epinastine HCl for allergic conjunctivitis. These approvals will expand the Company’s product offering and strengthen its brand presence.

The company will also continue to advance its commercialization efforts and better monetize its drug assets through in-house commercialization and global out-licensing activities.

Zhaoke will continue to proactively explore licensing and collaboration opportunities for its drug assets with global potential across Asia and in broader international markets, including the United States and Australia, aiming to accelerate the expansion of the Company's global footprint and reach.

Dr. Li concluded, “Zhaoke’s diligent efforts in R&D, registration and commercialization have laid a solid foundation for the future approvals and launches of its core products. We will build on this work over the rest of the year, continuing to prioritize resource allocation towards late-stage drug candidates, and accelerating the progress of clinical development and regulatory approvals. We believe this will position us to capitalize on the opportunities we see both in China and our other target markets. Looking ahead, we remain committed to driving sustainable and healthy growth and delivering enhanced value for our shareholders.”

- End -