By Fineline Cube Shanghai Haohai Biological Technology Co. Ltd. (SHA: 688366) announced that its trifocal toric intraocular lens (IOL) has been approved by the National Medical Products Administration (NMPA) for market launch. The product is indicated for visual correction in adult aphakic patients with cataracts and corneal astigmatism, aiming to correct corneal astigmatism while improving near, intermediate, and distance vision and reducing spectacle dependency.
Approval Overview
| Item | Detail |
|---|---|
| Company | Shanghai Haohai Biological Technology Co. Ltd. (SHA: 688366) |
| Product | Trifocal toric intraocular lens (IOL) |
| Regulatory Agency | NMPA (China) |
| Approval Pathway | National special approval procedure for innovative medical devices |
| Indication | Visual correction in adult aphakic patients with cataracts and corneal astigmatism |
| Market Status | First domestic trifocal toric IOL approved in China |
| Announcement Date | 7 Aug 2026 |
Product Profile & Technology
- Innovation: The product innovatively combines a trifocal diffractive optical design with toric astigmatism correction technology — a first among domestically developed IOLs in China.
- Dual Function: It effectively corrects corneal astigmatism while enhancing patients’ full‑range vision — near, intermediate, and distance — providing a more comprehensive visual solution for cataract patients with corneal astigmatism.
- Clinical Benefit: Designed to reduce spectacle dependency, addressing the quality‑of‑life expectations of an increasingly demanding cataract surgery population.
- Regulatory Significance: Approved through the national special approval procedure for innovative medical devices, underscoring its designation as a breakthrough domestic device.
Market Impact & Outlook
- Import Substitution: Premium multifocal and toric IOLs in China have been dominated by multinational suppliers — this approval makes Haohai the first domestic player in the trifocal toric segment, a milestone for China’s high‑end ophthalmic device industry.
- Large Addressable Base: China performs tens of millions of cataract surgeries annually, and corneal astigmatism affects a substantial share of cataract patients, making astigmatism‑correcting premium IOLs one of the fastest‑growing niches in ophthalmology.
- Premiumization Trend: As patients increasingly seek spectacle independence after cataract surgery, trifocal toric IOLs command premium pricing and represent the highest‑value tier of the IOL market.
- Competitive Positioning: First‑mover status in the domestic segment gives Haohai a pricing and tender advantage against imported alternatives in China’s hospital procurement system.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercialization plans and market adoption for Haohai’s trifocal toric IOL. Actual results may differ due to risks including hospital procurement dynamics, competitive responses, and surgeon adoption rates.-Fineline Info & Tech