On March 11th, Sinqi Eye Medicine’s stock price experienced significant volatility.
At 2:00 PM, Sinqi Eye Medicine, which had been down 1.5%, quickly turned positive and ultimately closed up by 12.88%. The catalyst was the news of its drug approval.
After the market closed, Sinqi Eye Medicine released a statement announcing that Atropine Sulfate SQ-729 had been approved for market launch, intended to delay the progression of myopia in children aged 6 to 12 with spherical diopters ranging from -1.00D to -4.00D (astigmatism ≤1.50D, anisometropia ≤1.50D).
The key point is that this is the first drug in China to be marketed for myopia prevention. What expectations does the market have for SQ-729?
1. The other side of the poison: delaying myopia
In 1831, German pharmacist Meine successfully purified atropine from belladonna, marking humanity’s first formal encounter with atropine.
Due to its toxicity, people have always been cautious about its application until 1978 when Professor Bedrossian in the United States developed atropine eye drops in minute doses to treat myopic children, astonishingly discovering that myopia was actually atropine’s core indication.
Since the 21st century, research on atropine in myopia control has gradually gained attention. The ATOM1 study by the Singapore Eye Research Institute (SERI) demonstrated the good effects of 1% atropine in controlling myopia progression (changes in refractive error and axial length) in children and adolescents.
Data from a 2-year trial comparing 1% atropine eye drops versus the control group showed: Myopia progression: -0.28±0.92D vs -1.20±0.69D. In other words, the degree of myopia in children treated with 1% atropine was 28 degrees, while it was 120 degrees in the control group.
However, because the 0.5% and 0.1% atropine groups experienced toxic side effects such as allergic conjunctivitis or dermatitis, the medical community embarked on exploration again, ultimately concluding that 0.01% atropine has similar efficacy to 0.1% and 0.5% atropine with relatively controllable toxic side effects.
Therefore, current exploration mainly focuses on 0.01% atropine. The approval obtained by Sinqi Eye Medicine this time is also for this concentration specification. In October 2022, Sinqi Eye Medicine announced the successful completion of a 1-year clinical trial of 0.01% atropine.
Based on these clinical results, Sinqi Eye Medicine applied for market approval for atropine and became the first in China.
2. New choice: filling the gap in the children’s market
In the consumer healthcare market, apart from products like growth hormone and botulinum toxin, perhaps the most anticipated is atropine, the miracle drug for delaying myopia.
Previously, atropine had gained popularity through in-hospital formulations. The core reason is the high demand in the market for delaying myopia.
According to Guosheng Securities, the size of the myopic population aged 6-16 is approximately 78 million.
For this part of the population, there are currently two major problems: some groups lack effective means of delaying myopia, while those with such means need more compliant and cost-effective solutions.
Currently, among the main measures for controlling and delaying myopia, wearing frame glasses, although convenient, has poor efficacy; optical correction (wearing orthokeratology lenses) is only suitable for those over 8 years old and requires certain requirements for myopia and astigmatism.
Surgical treatment is limited to those over 18 years old and is expensive.
The approval of atropine by Sinqi Eye Medicine this time fills the treatment gap for children aged 6-12. According to the company’s announcement, the approved clinical indications are: This product is used to delay the progression of myopia in children aged 6 to 12 with spherical diopters ranging from -1.00D to -4.00D (astigmatism ≤1.50D, anisometropia ≤1.50D).
In other words, there is now a new choice for the group of people who are already myopic and have degrees between 100 and 400.
3. The battle of the future: the prelude to a melee
In the market for delaying myopia, there are bound to be many entrants. As of now, including Zeke Ophthalmology, Hengrui Medicine, and Santen Pharmaceutical, many pharmaceutical companies have laid out plans and entered Phase 3 clinical trials.
Of course, from the current perspective, Sinqi Eye Medicine’s atropine has a certain first-mover advantage.
Among the latecomers, Zeke Ophthalmology has progressed the fastest. Its low-concentration atropine eye drops NVK002 announced positive TOPLINE data in bridge trials in October 2023. If we follow Sinqi Eye Medicine’s approval schedule, it should be approved around 2025.
In addition, including Hengrui Medicine and Santen Pharmaceutical, whose 2-year clinical trials may also yield clinical data in 2024. Overall, Sinqi Eye Medicine has only a short time to monopolize the race to delay myopia.
In response, Sinqi Eye Medicine has made corresponding preparations in its commercialization strategy. The company stated that it expects to focus on meeting the demands of customers who are already familiar with and trust the product within six months of its launch, covering their previously limited medication needs while also reserving some for new patients.
Six months later, it expects these new patients to become long-term stable users, expanding the base of existing patients while also reserving some for new patients. In the second year of the product’s launch, it will repeat the rhythm of the first year, but the base of existing patients and the proportion of new patients will further expand.
In other words, Sinqi Eye Medicine hopes to expand its compliant products in a “bringing new along with old” manner. So, what layouts can Sinqi Eye Medicine, with its first-mover advantage, achieve? How will the eventual atropine market evolve?