Hiteck Licenses Investigational Next-Generation NGF Eye Drop HT006.2.2 to Visara for Neurotrophic Keratitis Outside Greater China

The study will continue with an expansion phase evaluating the highest dose in six-times-daily and three-times-daily eight-week regimens.

Rhea-AI Summary

Hiteck (SZSE: 300683) entered an exclusive license agreement with Visara to develop and commercialize investigational eye drop HT006.2.2 outside Greater China. Visara, a majority-owned subsidiary of NovaBridge Biosciences (NASDAQ: NBP), plans to develop the neurotrophic keratitis treatment as VIS-102. Hiteck retains all rights in Greater China and will receive an upfront payment, with eligibility for milestone payments and tiered royalties on net sales.

In a Chinese Phase 1b study in severe neurotrophic keratitis, 50% of subjects in the highest-dose cohort achieved complete corneal healing after eight weeks. The vehicle control group recorded 14% healing at Week 4 before crossing to active treatment. Treatment-related ocular adverse events were all mild; none caused withdrawal or discontinuation.

8 points · 0 major

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointExclusive licensing agreement with Visara advances HT006.2.2 development and commercialization outside Greater China.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Upfront payment is payable to Hiteck under the license agreement.
• Minor point. Forward-looking: it has not happened yet and may not happen.Development, regulatory and commercial milestones provide eligibility for additional payments to Hiteck.
• Minor point. Forward-looking: it has not happened yet and may not happen.Tiered royalties on net sales are available to Hiteck under the agreement.
• Minor point50% complete corneal healing followed an eight-week course in the Phase 1b highest-dose cohort.

3 minor points

• Minor point43% complete corneal healing followed four weeks of active treatment after vehicle subjects crossed over.
• Minor pointNo related adverse event caused a subject to withdraw or discontinue the Phase 1b study.
• Minor point. Forward-looking: it has not happened yet and may not happen.Expansion phase will evaluate the highest dose in six-times-daily and three-times-daily eight-week regimens.

Negative

• Minor pointTreatment-related ocular adverse events occurred in Phase 1b, although all were mild.

News Explained

After the reported Phase 1b results, Hiteck says the Chinese study will continue into an expansion phase evaluating the highest dose in two eight-week schedules: six or three doses daily.

Key Figures

Complete corneal healing: 50% Complete corneal healing: 14% Complete corneal healing after crossover: 43% +2 more

Complete corneal healing

50%

Highest-dose cohort; after one 8-week course of HT006.2.2

Complete corneal healing

14%

Vehicle control group at Week 4; timing differs from the 8-week active-treatment result

Complete corneal healing after crossover

43%

Vehicle subjects after a 4-week course of HT006.2.2

Withdrawals due to related adverse events

0 subjects

Phase 1b study

Expansion-phase dosing regimens

6 times daily and 3 times daily, each for 8 weeks

Planned evaluation of the highest dose in Chinese patients with NK

Key Terms

neurotrophic keratitis, tiered royalties

2 terms

neurotrophic keratitis medical

"being developed for the treatment of neurotrophic keratitis (NK)"

A degenerative eye disease in which damage to the nerves that supply the cornea prevents normal healing, causing persistent surface breakdown, ulcers, scarring and potential vision loss. Think of it like a cut on the skin that you cannot feel and that doesn’t close because the repair signals are missing. It matters to investors because it defines patient populations, clinical trial endpoints, regulatory pathways and market need for therapies that restore corneal sensation or promote healing.

tiered royalties financial

"as well as tiered royalties on net sales"

Tiered royalties are a payment structure where the percentage of earnings paid as royalties changes based on different levels of sales or production. For example, a company might pay a smaller percentage on initial sales and a higher percentage as sales increase beyond certain points. This system encourages higher sales by adjusting payments, making it important for investors to understand how revenue sharing may vary as a product or project grows.

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Hiteck grants Visara, a majority-owned ophthalmology subsidiary of NovaBridge Biosciences (NASDAQ: NBP), exclusive worldwide rights, excluding Greater China, to develop and commercialize HT006.2.2

Hiteck retains all rights in Greater China, where a Phase 1b study in severe neurotrophic keratitis showed 50% complete corneal healing in the highest dose cohort after an 8-week course

HT006.2.2 is designed to offer a more convenient treatment option for patients with neurotrophic keratitis, building on Hiteck's longstanding expertise in nerve growth factor (NGF) therapeutics

WUHAN, China, Oct. 13, 2026 /PRNewswire/ -- Wuhan Hiteck Biological Pharma Co., Ltd. ("Hiteck") (SZSE: 300683) today announced that it has entered into an exclusive license agreement (the "License Agreement") with Visara, Inc. ("Visara"), a majority-owned ophthalmology subsidiary of NovaBridge Biosciences, for HT006.2.2, an investigational next-generation modified recombinant human nerve growth factor (rhNGF) eye drop being developed for the treatment of neurotrophic keratitis (NK). Visara plans to develop HT006.2.2 as VIS-102.

Under the terms of the License Agreement, Visara will receive exclusive rights to develop and commercialize HT006.2.2 worldwide excluding Greater China, and Hiteck retains all rights in Greater China. Hiteck will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments, as well as tiered royalties on net sales. A joint steering committee (JSC) will be responsible for the oversight and coordination of research and development activities under the License Agreement, technology transfer, management of the global development plan and expansion studies, information exchange, and such other functions as the parties may agree in writing.

In NK, damage to the corneal nerves impairs the eye's ability to heal, which can lead to persistent epithelial defects, corneal ulceration and permanent vision loss. Hiteck discovered and designed HT006.2.2 to make NGF therapy more practical for patients and caregivers, drawing on its experience with Aneway (Jinlujie), an NGF therapy that has benefited millions of patients in China. Through targeted modifications to the NGF amino acid sequence and formulation optimization, HT006.2.2 is designed to improve resistance to enzymatic degradation and remain stable under refrigeration, with formulation stability superior to that of existing products in the same class. This design may allow HT006.2.2 to potentially be supplied in ready-to-use, single-dose units, potentially easing the storage, shipping, handling and administration demands of current NK treatments.

HT006.2.2 showed a favorable safety profile in a first-in-human Phase 1 study, the results of which were published in the European Journal of Pharmaceutical Sciences. In a subsequent Phase 1b study in Chinese subjects with severe NK:

• In the highest dose cohort, 50% of subjects achieved complete corneal healing after a single 8-week course of HT006.2.2, compared with 14% of subjects in the vehicle control group at Week 4.
• Subjects on vehicle then crossed over to active treatment from Week 5 to Week 8, and 43% achieved complete corneal healing after a 4-week course of HT006.2.2.
• Treatment-related ocular adverse events were all mild and consistent with trials of rhNGF. No subjects withdrew or discontinued the study due to a related adverse event.

The study will continue with an expansion phase evaluating the highest dose at both 6 times daily and 3 times daily 8-week regimens in Chinese patients with NK.

"Nerve growth factor has long been central to Hiteck's science, and HT006.2.2 represents the next generation of that work, designed for stability and everyday practicality at the ocular surface," said Ya Chen, Chairman of Hiteck. "Visara's dedicated ophthalmology focus and global development capabilities make it a strong partner to advance this program internationally. This agreement is an important step in Hiteck's international strategy, and we look forward to working closely with Visara as we continue development in Greater China."

About HT006.2.2
HT006.2.2 is an investigational modified recombinant human nerve growth factor eye drop being developed for the treatment of neurotrophic keratitis. It has been evaluated in a first-in-human Phase 1 study and in a Phase 1b study in China, which will continue with an expansion phase. Its targeted amino acid sequence modifications and optimized formulation are intended to enhance resistance to enzymatic degradation and support stability at refrigerated temperatures, enabling a ready-to-use, single-dose format. Hiteck holds the rights to HT006.2.2 in Greater China, and Visara holds exclusive rights in the rest of the world, where the program will be developed as VIS-102.

About Neurotrophic Keratitis
Neurotrophic keratitis is a rare, degenerative corneal disease that occurs when the sensory nerves supplying the cornea are damaged. It can result from conditions such as herpetic eye infection, diabetes, or ocular and neurosurgical procedures. Without normal nerve function, the corneal surface loses both sensation and the trophic support it needs to repair itself. Over time, the disease can progress from persistent epithelial defects to corneal ulceration, stromal melting and perforation, and may result in permanent vision loss.

About Hiteck
Wuhan Hiteck Biological Pharma Co., Ltd. was founded in 1992 at the Medical School of Wuhan University and is a publicly listed biopharmaceutical company on the Shenzhen Stock Exchange (stock code: 300683). Guided by its mission of "Innovating for Life," Hiteck focuses on oncology, neurology and immunology, with a continued commitment to the development of innovative biologics and small molecule therapeutics. In oncology, Hiteck developed Aponermin, the world's first approved DR4 and DR5 agonist, which received regulatory approval in 2023 and was rapidly included in China's National Reimbursement Drug List (NRDL), introducing a novel therapeutic target for patients with relapsed or refractory multiple myeloma. In neurology, the company translated Nobel Prize-winning discoveries into clinical practice with Aneway (Jinlujie), one of the first nerve growth factor (NGF) therapies approved for clinical use, which has benefited millions of patients. Hiteck is also advancing HiTrans™, a transferrin receptor (TfR)-based brain delivery platform designed to facilitate the transport of therapeutics across the blood-brain barrier, with potential applications in central nervous system (CNS) diseases. For more information, please visit www.hiteckpharma.com.

About Visara
Visara is a clinical stage biotechnology company dedicated to developing next-generation biologic therapies for ophthalmic diseases affecting both the front and back of the eye. From the cornea to the retina, Visara pursues the full spectrum of ocular disease as vision is irreplaceable, and the unmet need is profound. Visara is a majority-owned ophthalmology subsidiary of NovaBridge Biosciences (NASDAQ: NBP). Its pipeline includes VIS-101, a tetravalent VEGF-A × ANG-2 peptibody being developed for neovascular retinal diseases, and VIS-102, a next-generation modified recombinant human nerve growth factor therapy being developed for neurotrophic keratitis.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential benefits of HT006.2.2, the clinical development plans and timing for HT006.2.2, and the anticipated achievement of milestones and receipt of payments under the License Agreement. Words such as "will," "expects," "believes," "designed to," "intends," "plans," "potential" and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties, including uncertainties inherent in clinical development, regulatory review and commercialization, which may cause actual results to differ materially. Milestone and royalty payments are contingent on future events and may not be received in full or at all. Hiteck undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Media Contact
Akim Zhou, Business Development
Wuhan Hiteck Biological Pharma Co., Ltd.
Email: bd@hiteck.com.cn
Website: www.hiteckpharma.com

View original content:https://www.prnewswire.com/news-releases/hiteck-licenses-investigational-next-generation-ngf-eye-drop-ht006-2-2-to-visara-for-neurotrophic-keratitis-outside-greater-china-302906928.html

SOURCE Wuhan Hiteck Biological Pharma Co., Ltd.

FAQ

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What rights did Hiteck license to NovaBridge subsidiary Visara for HT006.2.2?

Visara receives exclusive development and commercialization rights worldwide excluding Greater China, where Hiteck retains all rights. Visara plans to develop the investigational neurotrophic keratitis eye drop as VIS-102. Hiteck will receive an upfront payment and is eligible for milestone payments and tiered royalties on net sales.

What did Hiteck's HT006.2.2 Phase 1b study show in severe neurotrophic keratitis?

Complete corneal healing occurred in 50% of subjects in the highest-dose cohort after an eight-week course. Vehicle control subjects recorded 14% healing at Week 4, a different assessment time. All treatment-related ocular adverse events were mild, and none caused withdrawal or discontinuation.

What happened after control subjects switched to HT006.2.2 in Hiteck's Phase 1b study?

After switching from vehicle to active treatment, 43% of subjects achieved complete corneal healing after a four-week course of HT006.2.2. The crossover treatment ran from Week 5 to Week 8.

Who will oversee development under Hiteck's HT006.2.2 license agreement with Visara?

A joint steering committee will oversee and coordinate research and development under the agreement. Its responsibilities include technology transfer, management of the global development plan and expansion studies, and information exchange.