HONG KONG, Aug 3, 2022 – (ACN Newswire) – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or “the business”, SEHK: 6622), a respected ophthalmic pharmaceutical company focused on the study and development, manufacturing and commercialization of treatments that address significant unmet medical needs, is excited to announce that the individual enrollments for the two-year Phase III clinical trial (“China CHAMP”) and the concurrent one-year Phase III bridging clinical trial (“Mini-CHAMP”) of 1 of the business’s core products, NVK002, were completed on 21 July 2022 and 28 July 2022 respectively significantly before schedule.
The principal objective of the China CHAMP and Mini-CHAMP trials would be to measure the efficacy and safety of NVK002 for the treating myopia progression in children and adolescents.
— China CHAMP
Led by Principal Investigator Professor Wang Ning Li from Beijing Tongren Hospital , the China CHAMP trial involves 19 centers. Enrolment of 777 patients has been completed in under four months, 8 weeks before schedule.
Co-led by Principal Investigators Professor Qu Xiao Mei from the attention and ENT Hospital of Fudan University and Professor Yang Xiao from Zhongshan Ophthalmic Center, Sun Yat-Sen University , the Mini-CHAMP trial involves 18 centers and the enrolment of 526 patients has been completed in under three months, 90 days before schedule.
These early completions of patient recruitment across both trials, provides company a solid headstart in moving towards its goal to lead the marketplace in launching a myopia progression treatment drug.
In the usa and Europe, the business’s partner, Vyluma Inc., has been conducting a parallel Phase III clinical trial “CHAMP”, with 3 years of NVK002 treatment, and the trial is likely to complete in 2022. Third ,, a fresh Drug Application (“NDA”) submission to the united states Food and Drug Administration (the “FDA”) is expected in 2023. NVK002 happens to be regarded as probably the most likely first clinically-proven and approved pharmaceutical product for treating the progression of myopia on the planet.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology, said, “The first completion of the individual recruitment of NVK002’s Phase III clinical trials marks another huge and exciting milestone for Zhaoke Ophthalmology. Both China CHAMP and Mini-CHAMP trials completed the recruitment significantly before schedule. I’d like expressing my sincere gratitude to all or any members of our clinical operation team, who continue steadily to demonstrate superb clinical operations capability and expertise in the ophthalmology area. Our early completion of recruitment also clearly shows the immense demand and dependence on a safe and efficacious treatment for myopia progression control in China. Because of this achievement, Zhaoke Ophthalmology is hoping to commercialize NVK002 because the among the first low-dose atropine treatments for myopia progression in China, to be able to meeting this huge unmet need in the united kingdom, in addition to in South Korea and elements of Southeast Asia.”
NVK002 can be an investigational novel topical ophthalmic treatment for treat myopia progression in children and adolescents. The drug includes a proprietary formulation that successfully addresses the instability of low concentration atropine and contains a technology which has intellectual property protection globally. It really is preservative-free having an expected shelf life of over 24 months. In accordance with China Insights Consultancy (“CIC”), NVK002 happens to be probably 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 yrs . old.
The clinical development of NVK002 involves two different concentrations of atropine to permit flexibility in achieving maximal efficacy and minimal undesireable effects for tailoring to the requirements of individual patients.
About myopia progression control
Myopia has turned into a major social issue that plagues the growth of children and adolescents in China. In the “14th Five-Year National Health Plan” issued by hawaii Council of the Chinese government, clear instructions have already been designed for the prevention and treatment of myopia in children and adolescents, and make an effort to decrease the overall myopia rate among children and adolescents nationwide by a lot more than 0.5% each year. The Ministry of Education also issued the “Proposal for Parents of Comprehensive Prevention and Control of Myopia in Children and Adolescents”, contacting parents to cover focus on their children’s eye health.
In accordance with data from the planet Health Organization (“WHO”) and CIC, you can find currently approximately 700 million myopia patients in China, 163 million of these are children and adolescents, who might be able to reap the benefits of NVK002. Zhaoke Ophthalmology believes the potential commercialization of NVK002 allows the Company to determine a respected position in meeting these huge unmet needs in China.
Concerning the partnership
In October 2020, the business entered right into a license agreement, the NVK002 License Agreement, with Nevakar, which later transferred the agreement to its wholly-owned subsidiary, Vyluma, for a special license to build up, 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 information on the license agreement with regards to NVK002, please make reference to “Business – Collaborations and License Agreements – License of NKV-002” of the business prospectus dated April 16, 2021.
For more info about myopia in children, please feel absolve to pay attention to Episode 1 of our In Conversation with Zhaoke Podcast here. https://tinyurl.com/wut8fjzm
About Zhaoke Ophthalmology
Founded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is really a leading ophthalmic pharmaceutical company focused on the study and development, manufacturing and commercialization of therapies that address significant unmet medical needs on earth. The business was listed in the primary Board of the Hong Kong STOCK MARKET on 29 April 2021.
Zhaoke Ophthalmology includes a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both front and back of the attention. Most of the drugs are increasingly being stated in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.
Zhaoke Ophthalmology is concentrating on advancing towards the purpose of product commercialisation, and achieve the aim of improving visual health in China through scientific research as quickly as possible.
Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology’s goal would be to turn into a leader in ophthalmology on the planet.
To find out more, please visit: www.zkoph.com
About Vyluma, Inc.
Vyluma is really a development-stage biopharmaceutical company with a concentrate on pharmaceutical treatments for refractive errors of the attention. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to take care of myopia progression in children. NVK002 happens to be in late Phase III clinical development in the usa, Europe, and Asia.
Vyluma includes a robust pipeline of other assets in a variety of stages of development which address important unmet treatment needs of patients with refractive errors or eye pain.
Vyluma itself is really a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For more information please visit www.vyluma.com.
Diana Footitt, CEO
M: +852 9183 0667
Bowen Chui, Director
M: +852 9783 0643
Iris Pei, Director
M: +86 15000 465 016
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