By Fineline Cube Zhaoke Ophthalmology (HKG: 6622) announced that it has entered into an exclusive distribution and promotion agreement with Pengpai Bio for Epinastine Hydrochloride Eye Drops, covering all sales channels in Mainland China (excluding Hong Kong, Macao, and Taiwan) — a move designed to accelerate the commercial rollout of its newly approved ophthalmic generic across the country.
Deal Milestone
| Item | Detail |
|---|---|
| Parties | Zhaoke Ophthalmology (HKG: 6622) × Pengpai Bio |
| Agreement Type | Exclusive distribution and promotion agreement |
| Product | Epinastine Hydrochloride Eye Drops |
| Territory | Mainland China — all sales channels (excluding HK, Macao, Taiwan) |
| Announcement Date | 12 Aug 2026 |
| NMPA Approval | 19 Nov 2025 |
| Indication | Treatment of symptoms associated with seasonal allergic conjunctivitis |
Product Profile – Epinastine Hydrochloride Eye Drops
- Origin: Epinastine was originally developed by Allergan under the brand name Elestat, first approved for marketing in the European Union in 2003
- Development: The approved product is a generic drug independently developed by Zhaoke Ophthalmology, cleared by the NMPA on 19 Nov 2025
- Rapid Onset: Validated by the Conjunctival Allergen Challenge (CAC) model, the product demonstrates onset of action within 3 minutes post-administration
- Durable Effect: Therapeutic effects lasting for at least 8 hours, supporting convenient twice-daily or less frequent dosing
- Safety: A favorable overall safety and tolerability profile
Market Impact & Outlook
- Channel Coverage: The exclusive structure covering all Mainland China sales channels concentrates execution with Pengpai Bio, spanning hospitals, retail pharmacies, and online platforms — critical reach for an allergy-season-driven product.
- Seasonal Demand Driver: Seasonal allergic conjunctivitis affects a large patient population in China, with demand peaking in spring and autumn allergy seasons, giving the product a recurring commercial catalyst.
- Proven Molecule: Epinastine’s two-decade global clinical heritage under Elestat lowers prescriber and patient adoption barriers versus novel agents.
- Zhaoke’s Portfolio Strategy: The partnership converts Zhaoke’s November NMPA approval into commercial scale without building an in-house sales force for the channel, preserving capital for its pipeline.
- Next Steps: Financial terms, including distribution targets and revenue-sharing provisions, were not disclosed.
Forward‑Looking Statements
This brief contains forward-looking statements regarding the commercialization of Epinastine Hydrochloride Eye Drops in Mainland China. Actual results may differ due to risks including market adoption, pricing and competitive dynamics in ophthalmic allergy treatments, and channel execution.-Fineline Info & Tech