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Zhaoke Ophthalmology Enters Into A Distribution and Supply Agreement With Kwangdong Pharmaceutical To Commercialize NVK002 In South Korea
2023-03-28


HONG KONG, 27 March, 2023 – 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, is pleased to announce that the Company has entered into a distribution and supply agreement for NVK002, an atropine sulfate topical ophthalmic solution (the “Product”), which is a potential treatment for the progression of myopia in children and adolescents, with Kwangdong Pharmaceutical Co., Ltd. (“KDP” or “Kwangdong Pharmaceutical”), a leading Korean-based company principally engaged in the manufacturing and distribution of pharmaceutical products.


Under the terms of the agreement, the Company grants KDP exclusive rights to import, promote, distribute, market, and sell the Product in South Korea. The Company will receive an upfront payment and is eligible to receive additional milestone payments based on pending achievement of certain regulatory and sales milestones. KDP will purchase the Product in its finished form exclusively from the Company at an agreed transfer price.


Mr. Sung-Won Choi, CEO of Kwangdong Pharmaceutical (left), and Dr. Benjamin Li, Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology (right), have signed the Distribution and Supply Agreement for NVK002 Commercialization in Korea at the signing ceremony held in Seoul, Korea on 13 March 2023.


Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are delighted to partner with Kwangdong Pharmaceutical to distribute our atropine eye drop product NVK002 in South Korea, which highlights the enormous potential of NVK002 as a treatment for the progression of myopia in children and adolescents. This partnership is the first step in establishing Zhaoke Ophthalmology’s global footprint, and supports our plan to globalize NVK002 and other drugs in our pipeline in other territories including Southeast Asia, Europe and/or the United States. Our vision is to improve the global visual health by providing the world with access to our products”.


Dr. Lau Lit Fui, President and Chief Scientific Officer of Zhaoke Ophthalmology, said, “Kwangdong Pharmaceutical is a leading pharmaceutical company that ranks high in sales among 300 local pharmaceutical companies in South Korea, making it a very strong partner for our first distributorship deal. The prevalence of myopia is about 54% among Koreans across all age groups, with a particularly higher prevalence of 78.8% among children and adolescents[1]. We are confident that leveraging Kwangdong's significant presence in the South Korean market, NVK002 could be accessed by more local children and adolescents for potential myopia progression control. We hope to develop NVK002 into a novel drug product for myopia progression control among children and adolescents in the Greater China, South Korea and Southeast Asian territories”.


Sung-Won Choi, CEO of Kwangdong Pharmaceutical, said, “Kwangdong is focusing on the ophthalmology business as a new business sector, and NVK002 would be the flagship product that will take the lead. I am looking forward to the clinical trials and development in China because Korea and China are geographically close and have similar ethnic characteristics. Developing of NVK002 in the two counties will be more synergistic”.


NVK002 is an investigational, novel, atropine sulfate topical ophthalmic solution for use in the treatment for the progression of myopia in children and adolescents. It has a proprietary formulation that successfully addresses the instability of low-concentration atropine; this technology has intellectual property protection globally.  NVK002 is preservative-free with an expected shelf life of over 24 months. According to information from 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 from 3 to 17 years old.

In October 2022, the Company’s partner for NVK002, Vyluma Inc., (“Vyluma”) announced positive top-line results from its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study of NVK002. Analysis of this multi-center, international study, performed after three years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children and adolescents.


Vyluma plans to submit a New Drug Application (“NDA”) for NVK002 to the U.S. Food and Drug Administration (“FDA”) as early as Q1 2023. If approved by the FDA, NVK002 would be a first-in-class, clinically proven pharmaceutical agent for the treatment of myopia progression in children and adolescents.


About the partnership with Vyluma Inc.

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 (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.

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About Kwangdong Pharmaceutical Co., Ltd.

Kwangdong Pharmaceutical (KRX:009290) is a company focused on the development and commercialization of innovative medicines for the treatment of unmet medical needs. The company has a comprehensive drug portfolio of innovative and generic treatments covering Rx., OTC, and vaccines, and now they are planning to expand its new ophthalmology portfolio over the next few years. With the successive marketing in Rx., OTC, vaccine, and healthcare drink business, the company achieved total sales equal to over US$800M in 2022. Alongside its existing original portfolios, the company’s development efforts are focused on innovative ophthalmologic products through its ambitious strategy with partnering global pharmaceutical companies. 


About Zhaoke Ophthalmology Limited

Founded in 2017, Zhaoke Ophthalmology Limited (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021.

Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and the back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou, Guangdong Province.

Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialization, and achieving the objective of improving visual health through scientific innovation.

Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology’s goal is to become a global leader in ophthalmology.

For more information, please visit:  www.zkoph.com



[1]   “Factors associated with myopia in Korean children: Korea National Health and nutrition examination survey 2016–2017 (KNHANES VII)”, published by BMC Ophthalmology in January 2020


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Add: No. 1 Meide 3rd Road, Pearl River Industrial Park, Nansha District, Guangzhou
Hong Kong Headquarters
Tel: (852)23145100
E-mail: info@zkoph.com
Add: Unit 716, 7/F, Building 12W Phase 3, Hong Kong Science Park Shatin, Hong Kong
Wechat