Hiteck licenses neurotrophic keratitis eye drop HT006 to Visara

, /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.

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.

Website: www.hiteckpharma.com