· NVK002 currently positioned as the world-first treatment for slowing the progression of myopia
· Potentially the first to receive official approval as a treatment in China
HONG KONG, 23 March, 2022 – 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 treatments that address significant unmet medical needs, is pleased to announce that the first patient was enrolled in the two-year Phase III clinical trial (“China CHAMP”) of one of the Company’s core products, NVK002, on 16 March, 2022. The Company is also expecting the first patient to enroll in the one-year Phase III bridging clinical trial (“Mini-CHAMP”) in the near term.
The main objective of the China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 in myopia progression control of children and adolescents aged from three to 17 years old. The China CHAMP trial will include 19 medical centers and enroll 770 patients, led by Professor Wang Ning Li from Beijing Tongren Hospital as the Principal Investigator. Run concurrently, the Mini-CHAMP trial will include 18 medical centers and enroll 526 patients, led by Professor Qu Xiao Mei from the Eye and ENT Hospital of Fudan University as the Principal Investigator.
Globally, the Company’s partner, Vyluma Inc. (“Vyluma”), a wholly owned subsidiary of Nevakar Inc. (“Nevakar”), is conducting a trial of NVK002 in the United States and Europe, which is the most advanced study for drug registration of low dose atropine for slowing the progression of myopia and adolescents in the world. This trial, conducted over three years with NVK002, is expected to be completed before the end of 2022. A New Drug Application (“NDA”) submission to the United States Food and Drug Administration (“FDA”) is expected in 2023.
Including the China CHAMP and Mini-CHAMP studies, there are five different clinical trials in the United States, Europe and China, involving a total of 1,872 patients, making the total clinical data for NVK002 the most comprehensive, longest and verified among all atropine studies in the world. If the drug is approved by the US Food and Drug Administration (“FDA”), NVK002 will also be eligible for a real world study in Hainan Province, China. The treatment will be potentially available in the mainland Chinese market as early as 2024, which would make Zhaoke Ophthalmology the first company to have a myopia drug in the mainland market.
NVK002 is a potential novel topical ophthalmic solution to control myopia progression in children and adolescents. The drug has a proprietary formulation that successfully addresses the instability of low concentration atropine and has a technology that has intellectual property protection globally. It is preservative-free with an expected shelf life of over 24 months. According to China Insights Consultancy (“CIC”), NVK002 is currently one of the most advanced atropine drugs candidate globally for myopia progression control, and targets the broadest patient group, covering children and adolescents aged from three to 17 years old.
The clinical development of NVK002 involves two different concentrations to allow flexibility in achieving maximal efficacy and minimal adverse effects to tailor for individual patients.
According to data from the World Health Organization (“WHO”) and CIC, there are currently approximately 700 million myopia patients in China, 163 million of those are children and adolescents. The situation has accelerated given the COVID-19 pandemic and increased time spent on electronic devices, particularly by children and adolescents. CIC suggests that the market size of myopia in China is expected to grow from US$200 million in 2019 to US$3 billion in 2023, at a CAGR of 35.9%.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology, said, “this trial is a significant step in the development of NVK002. This drug has the potential to become the first approved product for slowing the progression of myopia in the world, positioning Zhaoke Ophthalmology as a market leader. Our mission remains to transform visual health, by developing best-in-class and first-in-class treatments. We aim to bring NVK002 to market as soon as possible in order to offer a treatment solution for young patients affected by myopia, and meet a significant unmet need in China, and globally.”
Professor Wang Ning Li, Beijing Tongren Hospital, said, “Myopia has always been one of the biggest public health concerns in China, and hundreds of millions of children and adolescents are suffering from the disease. However, currently there are no approved drugs for myopia progression control not only in China, but also globally. The initiation of this trial represents a very positive step towards the treatment of young myopia patients in China. Our team is excited to join hands with Zhaoke Ophthalmology to participate in the China CHAMP study and move closer to approving the first treatment option for myopia.”
About the partnership
In October 2020, the Company entered into a license agreement, the NVK002 License Agreement, with Nevakar, which later transferred the agreement to its wholly-owned subsidiary, Vyluma, for an exclusive license to develop, manufacture, register import and commercialize NVK002 in Greater China, South Korea and certain countries in Southeast Asia (included Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore Thailand and Vietnam). For details of the license agreement in relation to NVK002, please refer to “Business – Collaborations and License Agreements – License of NKV-002” of the Company prospectus dated April 16, 2021.