By Fineline Cube 
Zhaoke Ophthalmology (HKG: 6622) announced it has granted TSH Biopharm (TW-8432) exclusive rights to register, import, promote, distribute, market, and sell BRIMOCHOL PF in Taiwan. BRIMOCHOL PF is an experimental preservative-free, once‑daily eye drop for correcting near‑vision loss due to aging (presbyopia).
Licensing Agreement Overview
| Component | Details |
|---|---|
| Licensor | Zhaoke Ophthalmology (6622.HK) |
| Licensee | TSH Biopharm (TW-8432) |
| Territory | Taiwan |
| Product | BRIMOCHOL PF (carbachol/brimonidine tartrate fixed-dose combination) |
| Indication | Presbyopia |
| Rights | Exclusive registration, import, promotion, distribution, marketing, and sales |
Product Profile & Clinical Development
BRIO‑II Study Design:
- Type: Three‑arm, multi‑center, randomized, double‑masked study (NCT05135286)
- Arms: BRIMOCHOL PF, carbachol monotherapy, topical vehicle
- Population: Phakic and pseudophakic presbyopia patients
- Status: Completed; data supported US NDA filing
Key Product Features:
- Preservative‑free formulation reduces ocular surface toxicity
- Once‑daily dosing improves patient compliance vs. multi‑dose regimens
- Dual mechanism: Carbachol (miotic) + brimonidine (pupil optimization)
US Regulatory Context
- NDA Acceptance: US FDA accepted NDA in June 2025
- PDUFA Date: January 28, 2026 (target action date)
- Developer: Tenpoint Therapeutics, Ltd. (Zhaoke’s partner)
- Strategic Implication: US approval would validate platform and support Taiwan registration
Market Opportunity & Strategic Rationale
- Presbyopia Prevalence: 10 million adults aged 40+ in Taiwan affected by presbyopia
- Current Standard: Reading glasses or invasive surgical options; no approved pharmacologic therapy
- Market Gap: First‑in‑class topical treatment could capture 30‑40% of eligible patients
- Commercial Timeline: TSH Biopharm plans launch within 6 months of US approval
- Revenue Model: TSH will pay upfront/milestone fees plus royalties; Zhaoke retains manufacturing rights
Forward‑Looking Statements
This brief contains forward‑looking statements regarding BRIMOCHOL PF regulatory timelines, market launch, and commercial potential. Actual results may differ due to regulatory, competitive, and market access uncertainties.-Fineline Info & Tech