Nowadays, myopia problems in children are becoming more and more serious, and how to prevent and delay the development of myopia in children has become the focus of widespread parents' attention. As a result, various treatments have sprung up on the market, and related discussions have become more and more heated.

From traditional glasses to modern corneal shaping lenses, defocus lenses, and medication, parents are desperately seeking solutions suitable for their children, hoping to find the safest and most effective way to delay myopia as soon as possible.

Recently, Zhaoke Ophthalmology announced a simple new drug application for the drug NVK002 (0.01% low-dose atropine) to control the deepening of myopia in children, which was officially accepted by the State Drug Administration.

This means that NVK002 is expected to become the second approved low-concentration atropine eye drop in China, bringing new treatment options to hundreds of millions of myopic children in China.

So why was NVK002 able to break through? Is it worth the market choice? The logic behind this might be discussed.

1. The breakthrough was no accident; the certainty of the launch of the second domestic atropine was further enhanced

As a low-concentration atropine drug that specifically targets the progression of myopia in children and adolescents, NVK002's global research and development process has fully proved that its breakthrough in the market is no accident. The drug has carried out multiple clinical trials in various regions around the world, including North America, Europe, and China. It is currently the largest, longest, and most comprehensive Ato drug research project on the market.

According to reports, this simple new drug application for NVK002 is based on the Phase III Mini-CHAMP clinical study conducted by Zhaoke Ophthalmology in China.

In August 2023, Zhaoke Ophthalmology completed a one-year mini-CHAMP trial in China. The trial involved 16 centers and enrolled 526 patients.

Judging from clinical research results, Mini-CHAMP successfully reached its main efficacy end point, achieved significant statistical and clinical differences compared with placebo, and showed strong safety and efficacy as well as high patient tolerability. It can be seen that NVK002 has clinical application value in controlling the deepening of myopia in children.

At the same time, the dropout rate of patients in the Mini-CHAMP trial was less than 10%, and the dosage compliance of the subjects was as high as 95% or more. These data not only fully demonstrate the rigor and reliability of clinical research, but also further highlight the advantages of NVK002 in clinical applications and demonstrate its excellent clinical quality.

It is worth noting that NVK002's domestic registration application is based on Mini-CHAMP clinical trials. This means that Zhaoke's review in China does not require clinical trial data from US partners and is independent of the FDA's review process, thus ensuring the independence and flexibility of its marketing plan in China.

In addition to clinical trials for registration review, Zhaoke Ophthalmology also conducted a two-year Phase III China CHAMP clinical trial in China and completed the final visit of the last patient in August 2024. The positive top-line results of the trial proved that NVK002 has significant safety and efficacy, providing further data support as a potential treatment for controlling the deepening of myopia in children.

Overall, NVK002's successful breakthrough was not an accident, but a comprehensive reflection of its advantages in R&D, clinical trials, and market strategy. As the second atropine product in China to officially enter the review process, NVK002's progress has not only consolidated its leading position in the domestic market, but also further increased certainty about its successful launch. While this brings confidence to investors, it also provides strong support for the company's competitiveness in the market.

2. From approval of guidelines to market demand, atropine has become a mainstay in the field of myopia prevention and control

Today, myopia prevention and control has become a real problem that needs to be solved urgently, and atropine has shown huge market potential in this field and has become an important choice for solutions.

According to statistics from the National Health and Health Commission, the myopic population in the country has now reached about 0.7 billion people. In young people in particular, the prevalence of high myopia (greater than 600 degrees) is about 5% to 20%, far exceeding the international level by 5 to 10 times. Looking further, the overall myopia rate among children and adolescents was 52.7%, of which 35.6% were elementary school students, 71.1% were middle school students, and 80.5% were high school students. These data all show that the myopia prevention and control market has huge potential and demand.

Among many myopia prevention and control products, atropine eye drops have become a highly competitive single product due to their unique advantages and wide market recognition.

On the one hand, low-concentration atropine eye drops were included in the “Myopia Prevention Guidelines” for the first time, and their effectiveness was recognized at the national level. The “Guidelines for the Prevention and Treatment of Myopia (2024 Edition)” clearly states that low-concentration atropine eye drops are drugs that have been proven to be effective in delaying the progression of myopia through evidence-based medical verification.

On the other hand, numerous clinical trials at home and abroad have confirmed the safety and efficacy of low concentrations of atropine as a means of preventing and controlling myopia. From the ATOM series tests at the Singapore National Eye Centre and the Singapore Institute of Ophthalmology, to the LAMP test at the Chinese University of Hong Kong, to the official approval of the first domestic atropine in 2024, they all provided strong evidence support and full endorsement for the application of low-concentration atropine eye drops in myopia prevention and control.

Furthermore, atropine eye drops are convenient and economical to use. Although there are other myopia prevention and control products on the market, such as corneal shaping lenses and defocus lenses, etc., each has its own unique advantages and application scenarios, but it is necessary to go to the hospital regularly for review and maintenance during use. In contrast, atropine eye drops are simpler to use, can avoid the inconvenience caused by complex treatments, and are relatively affordable. At the same time, atropine eye drops can also be used in combination with other prevention and control measures to further improve the effectiveness of myopia prevention and control.

Of course, in order to achieve this market space, it is also necessary to go through the process of gradually replacing in-hospital formulations, and at the same time, it is necessary to cooperate with the company's marketing and sales strategies and the ability to enter the hospital. I believe that after time and factual testing, low concentrations of atropine will explode its enormous value and improve the quality of life of hundreds of millions of myopic children in China.

3. Summary

NVK002's “admission ticket” for atropine eye drops was undoubtedly an important milestone for Zhaoke Ophthalmology.

As the domestic marketing path of NVK002 became more clear, positive data from clinical trials also provided strong support for the review. The risk of approval was basically clarified, and the certainty of NVK002's marketing was further enhanced.

However, judging from market performance, the Hong Kong stock innovative drug sector has experienced continuous turbulence. The current market value of Zhaoke Ophthalmology is less than 0.7 billion yuan, which is even lower than its 1.27 billion yuan cash on hand. The company's valuation is clearly underestimated. With the gradual release of the commercial value of NVK002 and more products, it is expected that Zhaoke Ophthalmology's performance will continue to grow, which will bring the company stronger market recognition and ultimately drive an increase in its valuation level.