Santen Corporate (EN)

Santen New Drug Application Filing Accepted for Review in China for STN1012700 (Atropine Sulfate Ophthalmic Solution 0.025%), an Ophthalmic Solution to Slow the Progression of Myopia

September 14, 2026, Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter “Santen”) today announced that China’s Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for STN1012700 (atropine sulfate ophthalmic solution 0.025%) for slowing myopia progression. In Japan, the product has been available since April 2025 under the brand name RYJUSEA® Mini ophthalmic solution 0.025%.

STN1012700 contains 0.025% atropine sulfate as its active ingredient and is designed to slow myopia progression by suppressing ocular axial elongation. It is a preservative-free, unit-dose ophthalmic solution, designed to provide consistent dosing and support safe, long-term use in children.

Myopia has become a major public health concern affecting children and adolescents in China,  characterized by high prevalence, earlier onset, and rapid progression. According to data from China’s National Disease Control and Prevention Administration, the overall prevalence of myopia among children and adolescents in China was 51.9% in 2022, including 36.7% among primary school students, 71.4% among junior high school students, and 81.2% among senior high school students.1

The Guidelines for Myopia Prevention and Control (2024 Edition) issued by China’s National Health Commission include low-dose atropine ophthalmic solution as one of the evidence-based pharmacological interventions for slowing myopia progression,2 which expands the range of options available for the standardized control and management of myopia among children and adolescents.

Santen’s Chief Medical Officer, Peter Sallstig commented:
“The acceptance of the NDA for STN1012700 in China is an important milestone in our efforts to address the growing burden of myopia among children and adolescents. Earlier onset and longer progression of myopia are associated with an increased risk of high myopia, which can lead to sight-threatening complications.3-4 Our ambition is clear: at Santen, we strive to protect children from the lasting effects of myopia, both today and in the future. By raising awareness about myopia and shining a light on its importance, we hope to help children lead happier lives and build brighter futures. We will continue prioritizing the introduction of new therapies for people living with myopia worldwide.”

References

  1. National Disease Control and Prevention Administration. The Prevalence of Myopia Among Children and Adolescents in China Shows a Declining Trend. March 13, 2024.
  2. Guidelines for Myopia Prevention and Control (2024 Edition). Recent Advances in Ophthalmology. 2024;44(8):589-591.
  3. Verkicharla PK, et al. PLoS One. 2020;15:e0241759.
  4. Chua SYL, et al. Ophthalmic Physiol Opt. 2016;36:388–394.

About Santen
Santen is a global pharmaceutical company committed to advancing eye health and improving lives through better vision. Founded in 1890 in Osaka, Japan, Santen makes use of more than 135 years of experience in research and development, manufacturing, and marketing of pharmaceuticals and medical devices to help people around the globe maintain and improve their eye health. Santen focuses exclusively on eye health and its portfolio includes glaucoma, dry eye, infection, allergy, age-related macular degeneration, and myopia. Santen’s products and services are available in more than 60 countries and regions. Guided by its Core Principle “Tenki ni sanyo suru” – Exploring the secrets and mechanisms of nature in order to contribute to people’s health – Santen combines its expertise with deep patient focus to contribute to the realization of “Happiness with Vision.”
For more information, please visit https://www.santen.com/en.

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Santen Pharmaceutical Co., Ltd.
Corporate Communications
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This press release has been published in Japanese, Simplified Chinese and English and in the event of any inconsistency, the English version shall prevail.