Phase III clinical trial of NVK-002, a new myopia drug in Mega ophthalmology, is approved by the Drug Review Center.

美通社 · Sep 29, 2021 12:26

有望成为首款在中国上市的近视药物

或将成为全球首款缓减近视加深的药物

目标患者组别最为广泛，覆盖3至17岁
两项同时进行的临床试验，一项利用全球研究加快上市的时间
第III期临床试验研究为个别患者提供两种不同浓度

香港2021年9月29日 /美通社/ -- 致力于眼科疗法的研究、开发及商业化，以满足中国国内巨大医疗需求缺口的领先眼科制药企业兆科眼科有限公司（「兆科眼科」或「本公司」；香港联交所股份代号：6622）今天欣然宣布，有关在中国开展 NVK-002 为期两年的第 III 期临床试验（针对近视加深的儿童阿托品研究，又称「China CHAMP」研究）及为期一年的第 III 期桥接临床试验（「小型 CHAMP」）提交的新药临床试验申请（「新药试验申请」）已于2021年9月27日获中国国家药品监督管理局（「国家药监局」）药品审评中心（「药审中心」）批准。

第III期临床试验的主要目标为评估 NVK-002 对控制3至17岁儿童及青少年近视加深的疗效及安全性。China CHAMP 试验将涉及19间中心，入组770名患者，由北京同仁医院眼科中心王宁利教授出任牵头研究者。与此同时，同步进行的小型 CHAMP 试验将涉及18间中心，入组526名患者，由复旦大学附属眼耳鼻喉科医院瞿小妹教授出任牵头研究者。

在全球，兆科眼科的伙伴 Vyluma Inc.（「Vyluma」；为 Nevakar Inc.（「Nevakar」）的全资附属公司）正于欧美进行有关 NVK-002 的试验。该试验为全球最先进的药品注册研究，以低剂量阿托品缓减儿童及青少年的近视加深。为期三年的 NVK-002 试验预计于2022年底前完成，并预期于2023年向美国食品药品监督管理局（「FDA」）提交新药上市申请（「新药申请」）。

包括 China CHAMP 和小型 CHAMP 研究在内，现时美国、欧洲和中国进行5个不同的临床试验，共涉及1,872名患者，使 NVK-002 的最终临床数据在全球阿托品研究中最为全面、最长和经过验证。兆科眼科拟合并 Vyluma 的欧美第 III 临床试验数据与本公司在中国进行的小型 CHAMP 临床试验数据，以支持向国家药监局作出的 NVK-002 新药申请，及加速该新药的商业化。NVK-002 最快于2024年在中国内地市场推出，助力兆科眼科成为全球首间在中国内地市场推出用于治疗近视药物的公司。

NVK-002 是一种有可能用于控制儿童及青少年近视加深的新型外用眼部溶液。此新药为一项专利配方，能够成功解决低浓度阿托品的不稳定性，在全球受到知识产权保护。NVK-002 不含防腐剂，预计保存期超过24个月。根据灼识行业咨询的资料，NVK-002 目前为全球用于控制近视加深的最先进的阿托品候选药物，目标患者组别最为广泛，覆盖3至17岁的儿童及青少年。

NVK-002 的临床研究涉及两个不同浓度（即0.01%及0.02%浓度），让个别患者可灵活地在最少副作用下达致最大疗效。

根据世界卫生组织及灼识行业咨询的资料，中国目前有约7亿名近视患者。由于受到新冠病毒疫情及频繁使用电子产品等因素影响，目前情况正在加剧，尤其是儿童及青少年群体更甚。根据灼识行业咨询的数据显示，中国近视市场规模预计从2019年的2亿美元，增长至2030年的30亿美元，年均复合增长率达到35.9%。

兆科眼科董事会主席、执行董事兼行政总裁李小羿博士表示：「中国现时约有1.63亿名儿童和青少年患有近视，我们希望他们都能受益于 NVK-002。我们的策略是以全球临床试验与一项浓缩的本地研究相结合，这意味着我们不仅可以提供最佳的近视治疗，以满足庞大的需求缺口，为更多年轻人的生活带来改变。我们的目标为延缓下一代的近视加深，改善中国人民的视觉健康。」

China CHAMP 试验牵头研究者、北京同仁医院眼科中心王宁利教授表示：「我们很高兴与兆科眼科携手合作，引领 NVK-002 China CHAMP 第 III 期临床试验。近视已逐渐成为中国儿童和青少年面对的流行病，NVK-002 有望成为全球首个近视治疗方法，为中国患有近视的儿童和青少年的生活带来重大改善。」

小型 CHAMP 试验牵头研究者、复旦大学附属眼耳鼻喉科医院瞿小妹教授表示：「作为眼科医生，我们十分清楚近视问题在青少年群体中如何普遍。我们十分兴奋能够与兆科眼科共同领导 NVK-002 的小型 CHAMP 试验研究。此桥接研究应用了全球临床试验的结果，以一个创新方式来加速一款全球性药物在中国的临床发展，使中国患者可尽快得到治疗。」

关于兆科眼科与Nevakar的许可协议

于2020年10月，本公司与 Nevakar（Nevakar 其后将协议转让予其全资附属公司 Vyluma）就一项独家许可订立一份许可协议（即 NVK-002 许可协议），以于大中华、南韩及东南亚若干国家（包括汶莱、缅甸、柬埔寨、东帝汶、印尼、寮国、马来西亚、菲律宾、新加坡、泰国及越南）开发、制造、登记、进口及商业生产 NVK-002。有关 NVK-002 许可协议的详情，请参阅本公司日期为2021年4月16日的招股章程中「业务－合作及许可协议－NVK-002 的许可」一节。

如欲了解更多有关儿童及青少年的近视问题，欢迎收听「与兆科眼科对话」播客系列的第一集[连结]。

关于兆科眼科有限公司

兆科眼科（香港联交所股份代号：6622）成立于2017年，是一家领先的眼科制药企业，致力于眼科疗法的研究、研发及商业化，以满足全球巨大医疗需求缺口。兆科眼科于2021年4月29日在香港联交所主板上市。

兆科眼科已建立起包含25种由创新药及仿制药组成的候选药物，涵盖影响眼前节及眼后节的5种主要眼科适应症。众多药物现时由位于广州南沙最先进并功能齐全的开发及生产设施所制造。

凭借雄心勃勃的增长战略，包括与国内外制药公司携手合作，兆科眼科的目标是成为中国市场的领导者。

兆科眼科自成立以来，已获得众多蓝筹前期投资者的大力支持，当中包括新加坡政府投资公司、高瓴资本、TPG、正心谷资本、奥博资本、爱尔眼科医院及方源资本。兆科眼科近期完成于香港上市，并获得一众基石投资者包括 CaaS Capital、新加坡政府投资公司、Golden Valley、Jennison、Mass Ave、Matthews Asia、奥博资本及鼎佩投资参与。

欲查询更多信息，请浏览：www.zkoph.com

关于Vyluma Inc.

Vyluma Inc. 是一家专注于后期生物制药的私营公司，拥有针对屈光不正眼疾的全面眼科产品组合。Vyluma 总部位于新泽西州布里奇沃特，为 Nevakar Inc. 的全资子公司。Vyluma 拥有以 NVK-002 为首的强大的新型治疗组合，NVK-002 是一种不含防腐剂的药用阿托品眼部溶液，可缓减儿童近视的加深。NVK-002 目前处于第三期后期研发阶段，并已在美国和欧洲完成 CHAMP（Childhood Atropine for Myopia Progression，儿童阿托品近视控制）临床试验的注册。假若 NVK-002 的研发如期进行，它或成为全球首个获批使用阿托品眼部溶液来缓减儿童近视加深的治疗方法。

欲查询更多信息，请浏览： www.vyluma.com

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It is expected to be the first myopic drug on the market in China.

It may become the first drug in the world to reduce the deepening of myopia.

The target patient group is the most extensive and covered.3至17岁
Two simultaneous clinical trials, one using global research to accelerate time to market
第IIIPhase II clinical trial study provides two different concentrations for individual patients.

Hong Kong, September 29 / PRNewswire-Asianet /-- Mega Ophthalmology Co., Ltd. ("Mega Ophthalmology" or "the Company"), a leading ophthalmic pharmaceutical company dedicated to the research, development and commercialization of ophthalmology therapy to meet the huge medical demand gap in China. (Hong Kong Stock Exchange Stock Code: 6622) is pleased to announce today the launch of a two-year phase III clinical trial of NVK-002 in China (an atropine study in children with deepening myopia). The new drug clinical trial application submitted by the "China CHAMP" study) and the one-year Phase III bridging clinical trial ("mini CHAMP") (the "new drug trial application") was approved by the Drug Review Center ("Drug Review Center") of the State Drug Administration ("SDA") of China on September 27th, 2021.

The main objective of the Phase III clinical trial was to evaluate the efficacy and safety of NVK-002 in controlling the deepening of myopia in children and adolescents aged 3 to 17 years. The China CHAMP trial will involve 19 centers and 770 patients, with Professor Wang Ningli from the Ophthalmology Center of Beijing Tongren Hospital as the lead researcher. At the same time, the simultaneous mini-CHAMP trial will involve 18 centers with 526 patients in the group, with Professor qu Xiaomei from the Eye, Otorhinolaryngology Hospital of Fudan University as the lead researcher.

Globally, Mega Ophthalmology partner Vyluma Inc. ("Vyluma"; a wholly owned subsidiary of Nevakar Inc. ("Nevakar")) is conducting NVK-002 trials in Europe and the United States. The trial, the most advanced drug registration study in the world, relieves the deepening of myopia in children and adolescents with low-dose atropine. The three-year NVK-002 trial is expected to be completed by the end of 2022 and a new drug marketing application ("new drug application") is expected to be submitted to the US Food and Drug Administration ("FDA") in 2023.

Including China CHAMP and mini-CHAMP studies, five different clinical trials are currently being conducted in the United States, Europe and China, involving a total of 1872 patients, making the final clinical data of NVK-002 the most comprehensive and validated by CK Hutchison in the global atropine study. Mega Ophthalmology plans to combine Vyluma's Omeida III clinical trial data with the company's small CHAMP clinical trial data in China to support the application for a new NVK-002 drug to the State Drug Administration and to accelerate the commercialization of the new drug. NVK-002 will be launched in the mainland Chinese market as soon as 2024, helping Mega Ophthalmology to become the first company in the world to launch drugs for myopia in the mainland Chinese market.

NVK-002 is a new topical eye solution that may be used to control the deepening of myopia in children and adolescents. This new drug is a patented formula that successfully addresses the instability of low concentrations of atropine and is protected by intellectual property rights around the world. NVK-002 is preservative-free and is expected to have a shelf life of more than 24 months. According to cauterization Industry Consulting, NVK-002 is currently the most advanced atropine candidate in the world to control the deepening of myopia, targeting the widest range of patients, covering children and adolescents between the ages of 3 and 17.

Clinical studies of NVK-002 involve two different concentrations (0.01% and 0.02%), giving individual patients the flexibility to achieve maximum efficacy with minimal side effects.

There are currently about 700 million myopic patients in China, according to data consulted by the World Health Organization and the cauterization industry. Due to the epidemic situation of novel coronavirus and the frequent use of electronic products and other factors, the situation is getting worse, especially among children and young people. The size of China's myopia market is expected to grow from $200m in 2019 to $3 billion in 2030, with an average annual compound growth rate of 35.9 per cent, according to searing industry consultancy.

Li Xiao, Chairman, Executive Director and Chief Executive Officer of Mega Ophthalmology羿The doctor said:"at present, about 163 million children and teenagers in China are suffering from myopia, and we hope that they can all benefit from NVK-002. Our strategy is to combine global clinical trials with a concentrated local study, which means that we can not only provide the best treatment for myopia to meet the huge demand gap and make a difference to the lives of more young people. Our goal is to delay the deepening of myopia of the next generation and improve the visual health of the Chinese people. "

China CHAMPProfessor Wang Ningli, Ophthalmology Center of Beijing Tongren Hospital, lead researcher of the trial."We are pleased to work with Mega Ophthalmology to lead the NVK-002 China CHAMP Phase III clinical trial," he said. Myopia has gradually become an epidemic among Chinese children and adolescents, and NVK-002 is expected to become the world's first myopia treatment, bringing significant improvements to the lives of Chinese children and adolescents with myopia. "

Small sizeCHAMPThe lead researcher of the trial is Professor qu Xiaomei, Eye, Otorhinolaryngology Hospital affiliated to Fudan University."as ophthalmologists, we are well aware of how common the problem of myopia is among teenagers," he said. We are excited to co-lead NVK-002 's small CHAMP trial with Mega Ophthalmology. This bridging study applies the results of global clinical trials to accelerate the clinical development of a global drug in China in an innovative way, so that Chinese patients can be treated as soon as possible. "

About Mega Ophthalmology and OphthalmologyNevakarLicense agreement of

In October 2020, the Company entered into a license agreement (i.e. the NVK-002 license Agreement) with Nevakar (Nevakar subsequently transferred the agreement to its wholly-owned subsidiary Vyluma) for an exclusive license. Develops, manufactures, registers, imports and commercially produces NVK-002 in Greater China, South Korea and several Southeast Asian countries, including Brunei, Myanmar, Cambodia, East Timor, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam. For details of the NVK-002 license Agreement, please refer to the section entitled "Business-Cooperation and license Agreement-Licensing of NVK-002" in the Company's prospectus dated April 16, 2021.

To learn more about myopia in children and adolescents, please listen to the first episode of the podcast series Dialogue with Mega Ophthalmology.[Link]。

About Zhaoke Eye Co., Ltd.

Mega Ophthalmology (Hong Kong Stock Exchange: 6622), founded in 2017, is a leading ophthalmology pharmaceutical company dedicated to the research, development and commercialization of ophthalmology therapy to meet the huge global medical demand gap. Mega Ophthalmology was listed on the main board of the Hong Kong Stock Exchange on April 29, 2021.

Mega Ophthalmology has established 25 drug candidates consisting of innovative and generic drugs, covering 5 major ophthalmic indications that affect the anterior and posterior segments of the eye. Many drugs are currently manufactured by the most advanced and fully functional development and production facilities located in Nansha, Guangzhou.

With an ambitious growth strategy, including working with domestic and foreign pharmaceutical companies, Zhaoke Ophthalmology aims to become a market leader in China.

Since its establishment, Zhaoke Ophthalmology has received strong support from many blue-chip investors, including GIC, Hillhouse Capital, TPG, Zhengxin Valley Capital, Ober Capital, Ayre Eye Hospital and Fangyuan Capital. Mega Ophthalmology recently completed its listing in Hong Kong with the participation of a number of cornerstone investors, including CaaS Capital, GIC, Golden Valley, Jennison, Mass Ave, Matthews Asia, Ober Capital and Ding Pei Investment.

For more information, please visit www.zkoph.com

AboutVyluma Inc.

Vyluma Inc. Is a private company specializing in late-stage biopharmaceuticals with a comprehensive ophthalmic product portfolio for refractive eye diseases. Vyluma is headquartered in Bridgewater, New Jersey, for Nevakar Inc. A wholly owned subsidiary. Vyluma has a powerful new treatment combination led by NVK-002, NVK-002 is a preservative-free medicinal atropine eye solution that can reduce the deepening of myopia in children. NVK-002 is currently in the late phase III development phase and has completed the registration of CHAMP (Childhood Atropine for Myopia Progression, Child Atropine myopia Control) clinical trials in the United States and Europe. If the research and development of NVK-002 goes ahead as scheduled, it may become the first treatment approved in the world to use atropine eye solution to reduce the deepening of myopia in children.

For more information, please visit www.vyluma.com

兆科眼科近视新药NVK-002第三期临床试验获药审中心批准

Phase III clinical trial of NVK-002, a new myopia drug in Mega ophthalmology, is approved by the Drug Review Center.

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