By Fineline Cube 
Santen Pharmaceutical (TYO: 4536) announced that the New Drug Application (NDA) for its atropine sulfate 0.025% eye drops (RYJUSEA) has been accepted by China’s National Medical Products Administration (NMPA) for the proposed indication of delaying the progression of myopia. The acceptance marks a key regulatory step for the preservative‑free pediatric myopia control candidate in the world’s largest myopia market.
Regulatory Milestone
| Field | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Filing Type | New Drug Application (NDA) — accepted |
| Product | RYJUSEA (atropine sulfate 0.025% eye drops) |
| Proposed Indication | Delaying the progression of myopia |
| Company | Santen Pharmaceutical (TYO: 4536) |
| Date | 04 Sep 2026 |
| Next Steps | NMPA review of the NDA toward potential approval |
Drug Profile & Mechanism of Action
- Active Ingredient: Atropine sulfate, formulated at a 0.025% concentration.
- Mechanism: Controls myopia progression by inhibiting axial length elongation of the eye.
- Formulation Advantage: Preservative‑free design intended to ensure long‑term safety, particularly for pediatric patients.
- Target Population: Children and adolescents with progressing myopia, a population requiring chronic, safety‑sensitive treatment.
China Access Pathway – Hainan Boao Lecheng Pilot Zone
| Milestone | Detail |
|---|---|
| Policy Leveraged | “Designated medical device and drug” policy of the Hainan Boao Lecheng International Medical Tourism Pilot Zone |
| Regional Approval | RYJUSEA approved in Boao, Hainan — August 2025 |
| First Prescription | Issued at Hainan Eye & Optometry Hospital — September 2025 |
Leveraging the pilot zone’s special access policy, Santen Pharmaceutical secured regional approval for RYJUSEA in Boao, Hainan in August 2025, with the first prescription issued at Hainan Eye & Optometry Hospital in September 2025. That early‑access experience provided real‑world clinical application in China ahead of the nationwide NMPA NDA acceptance now announced.
Market Impact & Outlook
- Large Addressable Market: China carries an exceptionally high pediatric myopia burden, positioning RYJUSEA in a growing myopia control category.
- Differentiation: The preservative‑free, low‑concentration (0.025%) atropine sulfate formulation addresses long‑term safety concerns central to chronic pediatric use.
- Regulatory Momentum: NDA acceptance by the NMPA advances Santen toward potential nationwide commercialization, building on the Hainan Boao Lecheng early‑access approval.
- Portfolio Strength: The milestone reinforces Santen Pharmaceutical‘s ophthalmology franchise and its strategic commitment to the China market.
Forward‑Looking Statements — This brief contains forward‑looking statements regarding Santen Pharmaceutical‘s RYJUSEA (atropine sulfate 0.025% eye drops), including the NMPA review of the New Drug Application and potential approval for delaying the progression of myopia. Such statements are based on current expectations and are subject to risks and uncertainties, including regulatory review, clinical, and commercialization risks. Actual results may differ materially. Nothing herein constitutes investment advice or an offer to buy or sell any securities.-Fineline Info & Tech