Zhaoke Ophthalmology Gains Hainan Approval for YUVEZZI™, China’s First Innovative Presbyopia Therapy

Bulletin Express
07/07

On 26 June 2026 Zhaoke Ophthalmology Limited (Zhaoke Ophthalmology) obtained clearance from the Hainan Provincial Medical Products Administration to supply YUVEZZI™ (carbachol 2.75% + brimonidine tartrate 0.1% ophthalmic solution) to Boao Super Hospital as a “clinically urgent imported drug.”

The decision, granted under the State Council’s temporary adjustment of China’s Drug Administration Law within the Hainan Boao Lecheng International Medical Tourism Pilot Zone, enables the hospital to import limited quantities of the therapy exclusively for on-site clinical use.

Key points

• First-in-China status: YUVEZZI™ is the inaugural innovative drug approved domestically for presbyopia, a condition that typically affects individuals from age 45 onward. • Product profile: The once-daily, preservative-free eye drop induces pupil constriction, creating a pin-hole effect to improve near and intermediate vision. • Dual-agent formulation: Combines the cholinergic agent carbachol and the α2-adrenergic receptor agonist brimonidine tartrate in a fixed dose. • International benchmark: U.S. partner Tenpoint Therapeutics secured U.S. FDA approval for the same formulation in January 2026, signalling comparable regulatory recognition.

Regulatory pathway significance

Access via Boao Lecheng’s pilot scheme expedites availability of globally marketed therapies ahead of nationwide registration, offering presbyopia patients in China earlier treatment options while the standard National Medical Products Administration review continues.

Risk disclosure

Zhaoke Ophthalmology reiterates that successful commercialisation of YUVEZZI™ in mainland China is not guaranteed, and shareholders are advised to exercise caution when dealing in the company’s securities.

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