CsA Ophthalmic Gel will Become Zhaoke Ophthalmology’s First Innovative and Self-Developed Drug to Commercialize in China

HONG KONG, 9 June, 2022 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of treatments that address significant unmet medical needs, is pleased to announce that the New Drug Application (“NDA”) for Cyclosporine A (“CsA”) Ophthalmic Gel for the treatment of dry eye disease (“DED”) has been accepted by the Center For Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) on 8 June, 2022.

The Company previously conducted a pivotal Phase III clinical trial (“COSMO”) to evaluate the efficacy and safety of CsA Ophthalmic Gel in patients with moderate-to-severe DED. It involved 41 clinical trial centers with a total of 644 patients enrolled, and is the largest DED study completed to date in China. The recruitment for the trial started in December 2020 and was completed two months ahead of schedule in mid-April 2021.

In October 2021, the Company released the full results of the COSMO study for CsA Ophthalmic Gel. In this study, the mean (standard deviation (“SD”)) baseline inferior corneal staining scores (“ICSS”) was 3.0 (0.79), and the mean (SD) baseline Eye Dryness Score (“EDS”) was 65.8 (13.67). Compared to vehicle-treated patients, the CsA Ophthalmic Gel-treated patients showed statistically significant improvements in ICSS as early as Day 14 of treatment with continued and sustained improvements by Day 84. At the end of the treatment, 73.7% of CsA Ophthalmic Gel-treated patients showed a 1 point or greater improvement in ICSS versus 53.2% of patients on vehicle (p<0.0001). The mean change from baseline in EDS on Day 84 was 29.2mm (p<0.001) or 44.3% improvement in EDS over baseline. Treatment emergent adverse reaction was similar between CsA Ophthalmic Gel-treated and vehicle-treated patients with the most common side effect reported as eye pain reporting in 8.2% of all patients. In the COSMO study, CsA Ophthalmic Gel showed a faster onset of action by demonstrating efficacy at around the two-week time period, while other CsA drugs normally take around 7-8 weeks.

An abstract on the results of the Phase III clinical trial of CsA Ophthalmic Gel was selected by the Association for Research in Vision and Ophthalmology (“ARVO”) for presentation at the ARVO 2022 Annual Meeting in Denver, United States in May 2022. ARVO is the largest and one of the most respected eye and vision research organizations in the world, with a mission to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders. ARVO’s members include nearly 11,000 researchers from over 75 countries. Dr Parag Majmudar, Rush University Medical Center, Consultant of Zhaoke Ophthalmology, presented COSMO study results at ARVO.

CsA Ophthalmic Gel will become the Company’s first innovative and self-developed drug to commercialize in China. The Company believes its CsA Ophthalmic Gel is highly differentiated from other CsA class products currently available given its once daily application (instead of twice-daily for other CsA class products) and faster onset of action, both of which will reduce treatment burden and help increase physician and patient adoption.

Zhaoke Ophthalmology is actively establishing its innovative omni-channel coverage including traditional sales channels (public and private hospitals and distribution partners) and online platforms (online pharmacies, e-commerce and social media) to fully support commercialization of its pipeline of products, including CsA Ophthalmic Gel.

In March 2022, the Company signed strategic partnership agreements with three pharmaceutical commercial-logistics companies, including Sinopharm Group Distribution Co., Ltd., Shanghai Pharmaceuticals Co., Ltd., and China Resources Pharmaceutical Commercial Group Limited with a focus on distribution.

CsA Ophthalmic Gel is an innovative cyclosporine gel being developed by Zhaoke Ophthalmology in China for the treatment of DED. Unlike Restasis’® emulsion formulation, CsA Ophthalmic Gel is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles and exposure of CsA on the ocular surface, giving CsA more time to act against DED. The previous Phase II study results suggested that 0.05% CsA had efficacy and safety profiles at least similar to those of existing emulsion formulation Restasis® (0.05% CsA, b.i.d.). This means that unlike Restasis®, Zhaoke Ophthalmology’s CsA Ophthalmic Gel’s unique formulation requires only once a day application compared with traditional twice a day usage. By eliminating the daytime administration and associated discomfort and inconvenience, Zhaoke Ophthalmology’s CsA Ophthalmic Gel, which is administered once every night, is expected to significantly improve patients’ compliance, convenience, and quality of life. CsA Ophthalmic Gel also shows a faster onset of action by demonstrating efficacy at around two-week time, while other CsA drugs normally take around 7-8 weeks.

DED is one of the most prevalent eye diseases in China and globally. It is a complex multifactorial ocular surface disease involving inflammation and associated with different symptoms. According to China Insights Industry Consultancy Limited, the market size of DED drugs in China is forecasted to increase from US$430 million in 2019 to US$6.7 billion in 2030, at a compound annual growth rate of 28.4%. The number of DED patients in China is expected to grow from 214 million in 2019 to 266 million in 2030 with the diagnosis rate expected to increase from 11.5% in 2019 to 33.4% in 2030. Meanwhile, the number of DED patients in the United States is expected to grow from approximately 20 million in 2019 to approximately 28 million in 2030 with the diagnosis rate expected to increase from 47.4% in 2019 to 65.2% in 2030.

Dr. Li Xiaoyi (Benjamin), Chairman and CEO of Zhaoke Ophthalmology, said, “Our mission is to transform visual health in China, which is why we are incredibly excited that CsA Ophthalmic Gel will become Zhaoke Ophthalmology’s first innovative and self-developed drug to commercialize in China. Dry Eye Disease is one of the most common eye diseases in the world, affecting over 200 million people in China alone. CsA Ophthalmic Gel’s NDA marks an important step towards improving the standard of care for those patients affected by Dry Eye Disease. In addition to serving our core Chinese market, we intend to introduce this in-house developed innovative product to other countries and markets at a later stage.”