Zhaoke Ophthalmology’s IND Application for Potential First Myopia Drug to Market in China and Globally, NVK-002, Approved for Phase III Clinical Trial by the CDE

  • Targets broadest patient group – three to 17 years old
  • Two concurrent clinical trials, one leveraging global study to accelerate time to market
  • Phase III clinical trials testing two different doses to tailor for individual patients

HONG KONG, Sept. 29, 2021 /PRNewswire/ — Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or “the Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of treatments that address significant unmet medical needs, is pleased to announce that the investigational new drug (“IND”) application for NVK-002 to concurrently initiate a two-year Phase III clinical trial (The Childhood Atropine for Myopia Progression study or the “China CHAMP” study) and a one-year Phase III bridging clinical trial (“Mini-CHAMP”) in China has been approved by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) of China on 27 September 2021.

The main objective of the Phase III clinical trials is to evaluate the efficacy and safety of NVK-002 in myopia progression control of children and adolescents aged from three to 17 years old in China. 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 NVK-002 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 NVK-002, is expected to be completed by 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 NVK-002 the most comprehensive, longest and verified among all atropine studies in the world. The Company plans to combine global data from Vyluma’s clinical trial in the US and Europe with the results of the Company’s Mini-CHAMP trial in China to support an NDA submission to the NMPA and accelerate commercialization of NVK-002. The treatment will be potentially available in the mainland Chinese market as early as 2024, making Zhaoke Ophthalmology potentially the first company to place a myopia drug in the mainland market.

NVK-002 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”), NVK-002 is currently the most advanced atropine drug 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 NVK-002 involves two different concentrations (0.01% and 0.02%) 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. 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, Executive Director and CEO of Zhaoke Ophthalmology, said, “There are approximately 163 million children and adolescent myopia patients in China who we hope will be able to benefit from NVK-002. Our strategy to leverage the global clinical trials and bridge them with a condensed local study, means that we can deliver a potential first-in-class myopia treatment, to meet this huge unmet need and make a difference to the lives of so many young people. Our aim is to slow myopia progression for the next generation, transforming the visual health of people in China.”

Professor Wang Ning Li from Beijing Tongren Hospital, Principal Investigator for the China CHAMP study, said, “We are excited to partner with Zhaoke Ophthalmology to lead the China CHAMP Phase III clinical trial for NVK-002. Myopia is becoming an epidemic in China among children and adolescents, NVK-002 has the potential to be the first myopia treatment globally and will make a huge difference in the lives of children and adolescents in China who are suffering from myopia.”

Professor Qu Xiao Mei from the Eye and ENT Hospital of Fudan University, Principal Investigator for the Mini-CHAMP study, said, “As ophthalmic specialists, we know how prevalent myopia is among young people. We are thrilled to lead the Mini-CHAMP clinical trial for NVK-002 with Zhaoke Ophthalmology. This bridging study, leveraging the global clinical trial, is an innovative way to accelerate clinical development for a global asset in China and provide treatment to Chinese patients as quickly as possible.”

About the partnership

In October 2020, the Company entered into a license agreement, the NVK-002 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 NVK-002 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 NVK-002, please refer to “Business – Collaborations and License Agreements – License of NKV-002” of the prospectus of the Company dated April 16, 2021.

For further information about myopia in children, please feel free to listen to Episode 1 of our In Conversation with Zhaoke podcast here.

About Zhaoke Ophthalmology

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

Zhaoke Ophthalmology has a comprehensive drug portfolio of 25 innovative and generic treatments covering the five major eye diseases across both the front and back of the eye. Many of the drugs will be produced in its state-of-the-art development and production facility in Nansha, Guangzhou.

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

Zhaoke Ophthalmology has received strong endorsement from blue-chip pre-IPO investors, including GIC, Hillhouse Capital, TPG, Loyal Valley Capital, OrbiMed, Aier Eye Hospital and FountainVest. The Company recently completed its HK IPO with cornerstone investors including CaaS Capital, GIC, Golden Valley, Jennison, Mass Ave, Matthews Asia, OrbiMed and VMS Investment.

For additional information, please visit www.zkoph.com

About Vyluma Inc.

Vyluma Inc. is a privately held, late-stage biopharmaceutical company with an extensive portfolio of ophthalmic products focusing on refractive errors. Headquartered in Bridgewater, New Jersey, the Company is a wholly-owned subsidiary of Nevakar Inc. Vyluma has a robust pipeline of novel therapies led by NVK-002, a preservative-free, pharmaceutically-produced atropine eyedrop to slow the progression of myopia in children. NVK-002 is currently in late Phase III development and has completed enrollment of the CHAMP (Childhood Atropine for Myopia Progression) clinical trial in the United States and Europe. If NVK-002 stays on its current timeline it would potentially be the first approved treatment in the world using atropine eyedrops to slow the progression of pediatric myopia.

Additional information is available at www.vyluma.com