Wuhan Hiteck Biological Pharma Co., Ltd. (SHE: 300683) announced that it has signed an exclusive collaboration and licensing agreement with Visara, Inc., a U.S. clinical‑stage biopharmaceutical company focused on innovative ophthalmology therapies and a controlled subsidiary of Nasdaq‑listed NovaBridge Biosciences. Under the agreement, Visara will receive exclusive rights outside Greater China to develop, commercialize, manufacture (or contract‑manufacture), use, sell, offer for sale, import, export and otherwise exploit HT006.2.2 Ophthalmic Solution – the Company’s independently developed recombinant human nerve growth factor (rhNGF) eye drop for moderate‑to‑severe neurotrophic keratitis.
Deal Overview
| Term | Detail |
|---|---|
| Licensor | Wuhan Hiteck Biological Pharma Co., Ltd. (SHE: 300683) |
| Licensee | Visara, Inc. – Delaware, U.S.; founded September 2025; clinical‑stage ophthalmology biopharma; controlled subsidiary of Nasdaq‑listed NovaBridge Biosciences |
| Asset | HT006.2.2 Ophthalmic Solution – Class 1 therapeutic biologic with independent IP |
| Territory | Exclusive rights outside Greater China – development, commercialization, production/contract production, use, sale, offer for sale, import, export and other exploitation |
| Upfront + Near‑Term Milestones | USD 7 million, payable after agreement effectiveness |
| Development / Regulatory / Commercial Milestones | Up to USD 104 million |
| Royalties | A certain percentage of annual net sales in the licensed territory |
| Governance | Joint Steering Committee – three representatives per party – to be established within 30 days of the effective date, overseeing R&D coordination, technology transfer, global development plans and expanded studies |
| Governing Law | Hong Kong law |
| Approvals | Passed by the 9th Board of Directors at its 11th meeting; no shareholder approval required; not a related‑party transaction or material asset restructuring |
Asset Profile – HT006.2.2 Ophthalmic Solution
- Molecule: HT006.2.2, an ophthalmic formulation of recombinant human nerve growth factor (rhNGF), independently developed by Hiteck with independent intellectual property rights.
- Dual Target: Acts on Tropomyosin Receptor Kinase A (TrkA) and the p75 neurotrophin receptor (p75NTR) – the two NGF receptors governing corneal nerve survival, regeneration and epithelial healing.
- Engineering Innovation: Through targeted amino acid sequence modification and formulation optimization, the product demonstrates superior formulation stability, with the potential to overcome the stability limitations of existing comparable products – a known constraint in the rhNGF eye‑drop class.
- Clinical Indication: Intended for the treatment of moderate‑to‑severe neurotrophic keratitis (NK).
- Regulatory Status: Received its Drug Clinical Trial Approval Notice in October 2023 (Company Announcement No. 2023‑058); current clinical phase Not disclosed.
Disease Background
- Neurotrophic Keratitis: A degenerative corneal disease caused by impairment of trigeminal corneal innervation, leading to epithelial breakdown, persistent defects, ulceration and potential vision loss; moderate‑to‑severe stages carry high risk of corneal perforation.
- Limited Approved Therapies: Recombinant human NGF eye drops represent the only disease‑modifying approved pharmacologic class for NK globally, making next‑generation candidates with improved stability and dosing profiles highly sought after.
- Unmet Need: Patients with moderate‑to‑severe NK currently face limited options between supportive care, surgical intervention and a single branded biologic – underscoring the value of differentiated rhNGF formulations.
Market Impact & Outlook
- Internationalization Breakthrough: The transaction represents a major breakthrough in the internationalization of Hiteck’s biologic strategy, generating economic returns while enhancing brand value and overseas performance.
- Strategic Rationale: The agreement broadens HT006.2.2’s overseas markets, offering global patients a quality treatment option and accelerating Hiteck’s integration into the global drug innovation network through an international partner.
- Partner Pedigree: Licensee Visara – backed by Nasdaq‑listed NovaBridge Biosciences – brings a dedicated ophthalmology development focus, with good credit standing and no affiliation to Hiteck.
- Balanced Innovation Model: Hiteck continues its strategy of combining independent R&D with open collaboration, converting research outcomes rapidly and maximizing product value through leading international partners.
- Milestone‑Weighted Economics: The USD 7 million upfront/near‑term payment plus up to USD 104 million in milestones and net‑sales royalties ties the majority of deal value to clinical and commercial execution in ex‑China markets, where the NK opportunity is anchored by established biologic pricing.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development, technology transfer, milestone achievement and commercialization of HT006.2.2 Ophthalmic Solution under the Hiteck–Visara agreement. Actual results may differ materially due to risks including clinical trial outcomes, regulatory approvals outside Greater China, milestone timing, royalty realization, and competitive dynamics in ophthalmic therapies. The Company and its Board warrant that the disclosed information is true, accurate and complete, with no false records, misleading statements or material omissions.-Fineline Info & Tech
