· NVK002 is on track to be the world’s first approved treatment for slowing the progression of myopia
· Potential commercialization of NVK002 will help meet huge unmet need in China, South Korea and selected markets in Southeast Asia
HONG KONG, 20 May, 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 one-year Phase III bridging clinical trial (“Mini-CHAMP”) of one of the Company’s core products, NVK002, on 13 May 2022. In March 2022, the Company announced the first patient enrolled for the concurrent two-year Phase III clinical trial (“China CHAMP”), and as at 16 May 2022, China CHAMP has successfully enrolled 144 patients and is continuing the recruitment process.
The main objective of the Mini-CHAMP and China CHAMP trials is to evaluate the efficacy and safety of NVK002 in myopia progression control of children and adolescents. The China CHAMP trial will involve 19 centers and enroll 777 patients, led by Professor Wang Ning Li from Beijing Tongren Hospital as the Principal Investigator. The Mini-CHAMP trial will involve 18 centers and enroll 526 patients, co-led by Professor Qu Xiao Mei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from the Zhongshan Ophthalmic Center, Sun Yat-Sen University as the Principal Investigators.
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. NVK002 is currently positioned as the first approved product in the world with data for slowing the progression of myopia. If it is approved by the FDA in the United States, the drug will also be eligible for a real world study in Hainan Province in China.
China CHAMP and Mini-CHAMP have enrolled a total of 150 patients in China as at May 16, 2022. Together with Vyluma’s clinical study in the United States and Europe, the overall CHAMP trial will have the largest number of patients enrolled on a combined basis amongst all atropine program clinical trials globally, and with the longest and most comprehensive set of data on safety and efficacy.
NVK002 is an investigational 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 drug candidates 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 of atropine to allow flexibility in achieving maximal efficacy and minimal adverse effects for tailoring to the needs of 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, who may be able to benefit from NVK002. 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, “NVK002 is one of Zhaoke Ophthalmology’s core innovative products, and the enrolment of the first patient for the Mini-CHAMP is another important milestone as we look to commercialization in the future. This drug has great potential to become the world’s first approved treatment for slowing the progression of myopia. Currently, hundreds of millions of patients are suffering from myopia, and we strongly believe that NVK002 will allow Zhaoke Ophthalmology to establish a leading position in meeting this huge unmet need in China, South Korea and parts of Southeast Asia.”
Professor Qu Xiao Mei, Eye and ENT Hospital of Fudan University, said, “More and more young people in China are suffering from myopia and the COVID-19 pandemic has worsened the situation. I am very honoured to be partnering with Zhaoke Ophthalmology on this one-year Phase III clinical study of NVK002, which will provide treatment for myopia patients in China.”
Professor Yang Xiao, Zhongshan Ophthalmic Center at Sun Yat-Sen University, said, “Myopia is one of the most common eye diseases in China, affecting over 700 million people. We are very excited to partner with Zhaoke Ophthalmology and participate in the NVK002 Mini-CHAMP study to potentially develop a treatment which will benefit myopia patients in China and globally.”
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 select countries in Southeast Asia (including 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.