In front of the old domestic eye medicine leaders such as Yisheng Bio and Xingqi Eye Medicine, Zhaoke Ophthalmology is a young upstart.

In 2021, Zhaoke Ophthalmology successfully landed on the Hong Kong Stock Exchange as the second eye medicine biotechnology company with 25 ophthalmic drug candidates. Three years later, although it has not yet gotten out of the quagmire of losses, Zhaoke Ophthalmology is still working hard in the eye medicine track and finally ushered in the opportunity to overtake on the curve.

Two years of rapid growth, fierce attack on the "first billion drug"

Recently, Zhaoke Ophthalmology announced that the Phase III clinical trial (China CHAMP) of its eye medicine candidate NVK002 has achieved positive top-line results. NVK002 is an experimental new topical ocular solution for controlling the deepening of myopia in children and adolescents (using 0.01% and 0.02% low-dose atropine). This is the most popular atropine myopia prevention and control new drug under development after Xingqi Eye Medicine's atropine sulfate eye drops.

In October 2020, Zhaoke Ophthalmology introduced NVK002 from Nevakar and obtained the rights to develop and commercialize NVK002 in China, South Korea and Southeast Asia. After that, it has been working non-stop to promote the research and development of NVK002, because Zhaoke Ophthalmology is very clear that NVK002 is the most likely product to become a "hot item" among all candidates.

According to the latest data from the National Health Commission, among the population over 5 years old in China, there are 600 million myopic patients, almost twice the total population of the United States. What is more worrying is that the myopia rate among young people is showing an increasing trend year by year. According to the survey, the prevalence of myopia in the 5-15 age group is expected to reach 77.42% in the future, and even as high as 94% in the 16-24 age group.

This large and continuously growing target population provides a broad space for the development of the myopia prevention and control market. According to CICC's estimates, the scale of the myopia prevention and control market is expected to reach about 210 billion yuan in 2030, with a compound growth rate of about 13.7% over ten years. At present, myopia correction and prevention measures mainly include frame glasses, corneal contact lenses, surgical correction and drug treatment.

Atropine in drug treatment works through multiple mechanisms, including affecting the relevant receptors of the retina and the posterior sclera, and through cholinergic, G-protein and other signaling pathways, while maintaining a relatively good myopia control effect, the adverse reactions are relatively mild. At present, atropine eye drops are the only drug that has been verified by evidence-based medicine and can effectively delay the progression of myopia. Its significant clinical value will subvert the ophthalmic market dominated by instruments and consumables in the past. At present

, low-concentration atropine (mainly 0.01%) preparations have been listed in countries with a high incidence of myopia, such as Singapore and Japan, with an average annual use cost of about 3,000-4,000 yuan. If calculated at an annual cost of 1,500 yuan (lower than 1/5 of the cost of surgery and orthokeratology lenses), the theoretical market space for atropine preparations will be as high as 120 billion yuan.

Xingqi Eye Drops has taken the lead in the 100 billion blue ocean market for myopia prevention and control. In March this year, Xingqi Eye Drug's 0.01% atropine sulfate eye drops (SQ-729, trade name: Meioupin) was approved by NMPA for listing, which is used to delay the progression of myopia in children, becoming the first low-concentration atropine sulfate eye drops listed in China to delay the progression of myopia in children.

As expected, Xingqi Eye Drug's revenue and net profit increased significantly after Meioupin was launched. The financial report shows that Xingqi Eye Drug's eye drops business recorded revenue of 512 million yuan in the first half of 2024, a year-on-year increase of 62.97%. In the second quarter, it achieved revenue of 542 million yuan, a month-on-month increase of 54.89%, and a net profit of 135 million yuan attributable to the parent, a month-on-month increase of 287.27%, mainly because Meioupin quickly "produced milk".

At present, Xingqi Eye Drops is rapidly laying out sales channels across the country, and Meioupin is still rapidly increasing in volume, and the peak is far from coming. According to relevant data from Debon Securities, the total number of children and adolescents who are mainly responsible for myopia prevention and control with low-concentration atropine is nearly 100 million. The annual cost of the current mainstream atropine in-hospital preparation is about 3,600 yuan. It is expected that Meioupin will reach its sales peak in the third full year of listing (2027), reaching 10.18 billion yuan.

Now, after two years of crazy catching up, Zhaoke Ophthalmology has already been at the gates of the city. If NVK-002 is successfully declared and approved for listing, Meioupin's market exclusivity will end.

The track is crowded, is the chance of winning high?

In addition to Xingqi Eye Drops and Zhaoke Ophthalmology, the 100 billion market for atropine eye drops has also gathered many players. According to data from the Debon Securities Research Institute, related products of many domestic companies such as Hengrui Medicine, Jimu Bio, Santen Pharmaceutical, and Ocuvision have reached the Phase III clinical stage.
Among them, Hengrui Medicine's HR19034 eye drops are running faster, and it was registered for Phase III clinical trials in September 2021, 2 months ahead of Zhaoke Ophthalmology in registration time. The Phase III trial is to evaluate the effectiveness and safety of the drug. The treatment cycle is 144 weeks (about 3 years), and multiple clinical endpoints including the primary endpoint are set at 96 weeks and 48 weeks, which are currently underway.

In addition, Ocumension's OT-101 completed the Phase III international multicenter clinical patient enrollment in June 2023 (enrollment in China was completed in February). Ocumension designed a 3+1 research cycle, and the clinical trial is expected to end in 2026H2 or 2027.

In November 2023, Qilu Pharmaceutical also registered a multicenter, randomized, open, placebo-controlled Phase III study (NCT06151587) on the official website of Clinicaltrials.gov, which aims to evaluate the efficacy and safety of different concentrations of atropine eye drops (QLM3004) in delaying the progression of myopia in children. It is expected to be completed in June 2027.

The competition in the atropine eye drops track has been full due to the eager eyes of many domestic companies. As the first company to break through, Xingqi Eye Drugs also feels the pressure. In addition to promoting the rapid volume growth of American and European products, it also develops 0.02% and 0.04% atropine sulfate eye drops that are different from American and European products. Recently, Xingqi Eye Drugs announced that the Phase III clinical trial of 0.02% and 0.04% atropine sulfate eye drops has been successful.

Obviously, the competition in the field of atropine myopia prevention and control will be quite fierce in the future, but Zhaoke Ophthalmology has a winning secret, because NVK002 has a differentiated advantage. Research data show that NVK-002's proprietary dosage form can successfully solve the problem of low-concentration atropine instability. At the same time, compared with the target age of 6-12 years old for Meioupin and 3-15 years old for Ocuvision Bio's products, NVK-002 covers children and adolescents aged 3 to 17 years old. It is currently an atropine eye drop product with the widest target patient group.

In addition, the formula of NVK-002 does not contain preservatives, and the expected shelf life is at least 24 months, which has stronger commercial appeal.

In this way, NVK-002 has the potential to become a large single product of tens of billions.

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