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Podcast Series Episode 5: Transforming the Visual Health of Young People in China
2021-11-09


Lisa Feng 0:02

Hello, and welcome to our In Conversation with Zhaoke, Podcast Series, where leading scientists will exchange views with doctors, surgeons, and other experts in the Ophthalmology field. We will discuss a number of issues affecting the eye, which impact tens of millions of patients each year. We will also focus on several drugs we have in our pipeline which we believe will provide future solutions and relief to patients as well as providing context on the ophthalmology market in China.

I’m Lisa Feng, Chief Financial Officer of Zhaoke Ophthalmology. In today’s episode, I will be discussing exciting news regarding an innovative treatment for myopia with the Founder, Chairman and CEO of Zhaoke Ophthalmology, Dr. Benjamin Li, and Dr. Alvin Kwok, one of the leading ophthalmologists in Hong Kong and our expert consultant.

Dr. Benjamin Li has over 25 years of experience in pharmaceutical research and development. Since 2014, he has been serving as the Vice President of the Hong Kong Biotechnology Organization, and since 2016 he has been the President of the Guangzhou Pharmaceutical Organization. Dr. Li has won multiple awards for his work and is an Adjunct Professor and Honorary Fellow at the Hong Kong University of Science and Technology.

Dr. Alvin Kwok is the Editor-in-Chief of the Hong Kong Journal of Ophthalmology, an Honorary Associate Professor at The Chinese University of Hong Kong, and Honorary Clinical Associate Professor at the University of Hong Kong. Alvin has won numerous awards for his work in the ophthalmology field.

If you have listened to our first episode – and if you haven’t, I would encourage you to do so – we discussed the causes and current treatments for what is one of the most common eye disorders worldwide. Myopia is the leading cause of preventable blindness in children and adolescents, and it affects more than 160 million children and adolescents in China according to the data from the World Health Organization and China Insights Consultancy. Today, we are thrilled to share some exciting news from Zhaoke Ophthalmology that could Transform the visual health of young people in China.

Lisa Feng 2:44

Dr. Li, Dr. Kwok, welcome and thank you for joining us again to discuss the potential first myopia drug to market in China and globally. So, let’s not keep our listeners waiting. We have a very important update on NVK-002. Zhaoke Ophthalmology announced in late September that the application for the investigational new drug, or IND, for Phase III clinical trials for NVK-002 has been approved by the Center for Drug Evaluation or CDE of the National Medical Products Administration of China.

It is clearly a big step forward in the development of the treatment, and means that if all goes well, Zhaoke Ophthalmology may have a billion-dollar drug in its portfolio of ophthalmology assets! Dr. Li and Dr. Kwok, we are all really excited about this important milestone for the company. What does this really mean for the people who suffer from myopia?

Dr. Li 3:55

Thank you. I’m thrilled that we are getting closer to bringing to market potentially the world’s first treatment for slowing the progression of myopia. NVK-002 targets the widest age group amongst competitive programs with multiple concentration levels, in an effort to bring benefits to as many patients as possible.

Dr. Kwok 4:20

Indeed. Myopia is one of the most common eye diseases in the world and unfortunately becoming more and more common among children. The risk factors for developing pediatric myopia are mainly genetics, increased screen time and decreased time spent outdoors, leading to an escalation, or even an epidemic, of the disease. The situation has accelerated given the COVID-19 pandemic and increased time spent on electronic devices, particularly by children and adolescents. What many people don’t know is that if we take action as early as possible, myopia can actually be reduced or treated.

Lisa Feng 5:05

And this is where this new treatment NVK-002, comes into the picture. Dr. Li, could you share more details about the Phase III Clinical Trials for which we have received the IND approval?

Dr. Li 5:18

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. We will initiate two concurrent Phase III clinical trials, a two-year China CHAMP study and a one-year bridging trial known as Mini-CHAMP, which will leverage the results of the existing global study to accelerate the treatment’s time to market in China.

The China CHAMP trial will include 19 medical centres and enrol 770 patients, led by Professor Wang Ning Li from Beijing Tongren Hospital as the Principal Investigator. The Mini-CHAMP trial will run at the same time and will include 18 medical centres and enrol 526 patients, led by Professor Qu Xiao Mei from the Eye and ENT Hospital of Fudan University as the Principal Investigator.

Globally, Zhaoke Ophthalmology’s partner Vyluma Inc., a wholly owned subsidiary of Nevakar Inc., 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 in children and adolescents in the world. This is a three-year study and expected to be completed by the end of 2022.

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. We plan to combine global data from Vyluma’s clinical trial in the US and Europe with the results of Zhaoke Ophthalmology’s Mini-CHAMP trial in China to support a New Drug Application or NDA submission to the NMPA in order to accelerate commercialization of NVK-002.

Dr. Kwok 7:54

The bridging study, leveraging the global clinical trial, is certainly an innovative way to accelerate clinical development for a global asset in China and provide treatment to Chinese patients as quickly as possible. Our team at the Chinese University of Hong Kong has published many research findings on low dose atropine. These findings prove that low dose atropine is the only medication to date that is safe and effective in controlling the progression of myopia. However, atropine needs to be diluted before use and the compound is unstable at a low dose, meaning that its shelf life is not very long. Has NVK-002 addressed this issue?

Dr. Li 8:39

Yes indeed. NVK-002 has a proprietary formulation that successfully addresses the instability of low concentration atropine. This technology has intellectual property protection globally. It is preservative-free with an expected shelf life of over 24 months.

Dr. Kwok 9:01

This drug sounds like it will make a huge difference in the lives of children and adolescents who are suffering from myopia.

Dr. Li 9:09

You are totally right. According to 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. In addition, 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.

Dr. Kwok 9:52

When will the treatment be available?

Dr. Li 9:55

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 Chinese market.

Lisa Feng 10:12

Not only does NVK-002 have the potential to help hundreds of millions of people worldwide, but we also expect commercializing NVK-002 in China to be one of the biggest milestones for Zhaoke Ophthalmology in the next three years in terms of business growth. For context, 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 26%.

According to data from the WHO and CIC, there are currently approximately 700 million myopia patients in China, out of which, approximately 163 million are children and adolescents. Right now, hospital formulary of low dose atropine, which is not stable, so not an officially approved drug, is available in China and costs about RMB300 per patient per month – and people buy it! When our NVK-002 is approved, as a low dose atropine drug with a stable shelf life, and excellent safety and efficacy profile. Even if we just convert a small percentage of the target patient population, revenue and margin contribution to Zhaoke will be very significant.

Dr. Kwok 11:43

That is impressive. What is your commercialization strategy?

Lisa Feng 11:47

The ratio of ophthalmologists to general practitioners in China is about 1:17, which means relative to other common diseases, we can reach our target physician population with a much smaller sales team. We will adopt a multi-pronged approach to cover public hospitals, rapidly growing private eye hospitals and OTC and e-commerce platforms.

Chinese parents spare no expense when it comes to their children’s wellbeing, and they are all smart customers. We believe superior product quality and brand integrity are key to success in this category.

NVK-002 will first be manufactured by Vyluma’s manufacturing partner in Europe. However, we also plan to introduce the production process to our state-of-the-art facility located in Nansha, Guangzhou.

Dr. Li 12:43

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 as quickly as possible, 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.

Lisa Feng 13:18

Wonderful note to finish our episode. Thank you, Dr. Li and Dr. Kwok, for your time today. I hope you have enjoyed listening to our podcast. Please feel free to listen to our previous episodes. We look forward to talking to you again soon in the next episode of our In Conversation with Zhaoke Podcast Series. Thank you.



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Guangzhou Headquarters
Tel: 020-39062888
E-mail: info@zkoph.com
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