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资讯 2026年10月13日，武汉海特生物制药股份有限公司（以下简称“海特生物”，股票代码：300683）宣布，与NovaBridge Biosciences（纳斯达克：NBP）旗下控股眼科子公司Visara, Inc.（以下简称“Visara”）签署独家许可协议，将公司自主研发的新一代修饰型重组人神经生长因子（rhNGF）滴眼液HT006.2.2在大中华区以外的全球开发及商业化权益独家授予Visara。HT006.2.2拟用于治疗神经营养性角膜炎（NK），Visara将以VIS-102作为该项目的开发代号。
根据协议，海特生物将获得首付款，并有权获得开发、注册及商业化里程碑付款，以及基于产品净销售额的分级销售提成。JSC（联合指导委员会）负责本协议项下研发活动的监督与协调、技术转移、全球研发计划及扩展研究的管理、信息交流，以及双方书面授予的其他职能。海特生物保留HT006.2.2在大中华区的全部权益，并将持续推进其在国内的临床开发。
海特生物董事长陈亚表示：“神经生长因子是海特生物长期深耕的核心领域，HT006.2.2是我们在这一领域的新一代成果。Visara专注眼科、具备全球开发能力，是推进该项目国际开发的理想合作伙伴。此次合作是公司国际化战略的重要一步，我们将与Visara紧密协作，同时持续推进HT006.2.2在大中华区的开发，让更多患者早日获益。”
深耕NGF领域
打造新一代眼表治疗方案
神经营养性角膜炎是一种由角膜神经受损引起的罕见眼病。患者角膜的自我修复能力下降，可出现持续性上皮缺损、角膜溃疡，严重者可导致永久性视力丧失。
海特生物在神经生长因子领域深耕多年，旗下金路捷已惠及国内数百万患者。基于这一积累，公司自主研发了HT006.2.2，致力于让NGF疗法用起来更方便。该产品通过氨基酸序列的靶向修饰和制剂处方优化，制剂稳定性优于现有疗法的同类产品，旨在提升抗酶降解能力，并实现冷藏条件下的稳定储存，有望以即用型单剂量包装供应，从而减轻现有治疗在储存、运输、操作和给药等环节的负担。
早期临床数据积极
HT006.2.2首次人体I期临床研究结果已发表于国际期刊European Journal of Pharmaceutical Sciences，显示出良好的安全性。在随后针对中国重度NK受试者开展的Ib期研究中：
?最高剂量组经单个8周疗程治疗后，角膜完全愈合率达50%；溶媒对照组第4周角膜完全愈合率为14%；
?溶媒组受试者于第5周起转换为HT006.2.2治疗并持续至第8周，完成该4周疗程后角膜完全愈合率达43%；
?治疗相关眼部不良事件均为轻度，与既往rhNGF临床试验结果一致，无受试者因相关不良事件退出或中止研究。
下一步，该研究将进入扩展阶段，在中国NK患者中评估最高剂量每日6次和每日3次两种8周给药方案。
关于HT006.2.2
HT006.2.2是海特生物自主研发的在研修饰型重组人神经生长因子滴眼液，拟用于治疗神经营养性角膜炎。该产品已完成首次人体I期研究，目前正在中国开展Ib期研究，后续将进入扩展阶段。通过氨基酸序列靶向修饰和制剂处方优化，HT006.2.2旨在增强抗酶降解能力、实现冷藏稳定储存，并采用即用型单剂量包装。海特生物拥有该产品在大中华区的权益，Visara拥有其在全球其他地区的独家权益，并将以VIS-102为代号推进开发。
关于神经营养性角膜炎
神经营养性角膜炎是一种罕见的退行性角膜疾病，由支配角膜的感觉神经受损引起，常见诱因包括疱疹性眼部感染、糖尿病以及眼科或神经外科手术等。神经功能受损后，角膜会同时丧失知觉和自我修复所需的营养支持，病情可由持续性上皮缺损逐步进展为角膜溃疡、基质溶解乃至角膜穿孔，并可能导致永久性视力丧失。
关于海特生物
武汉海特生物制药股份有限公司于1992年创立于武汉大学医学院，是深圳证券交易所创业板上市公司（股票代码：300683）。海特生物聚焦肿瘤、神经及免疫领域，持续致力于创新生物药和小分子药物的研发。在肿瘤领域，海特生物研发的沙艾特?（注射用埃普奈明）是全球首个获批上市的DR4/DR5激动剂，于2023年获批并迅速纳入国家医保目录，为复发或难治性多发性骨髓瘤患者带来全新治疗靶点。在神经领域，公司将诺贝尔奖成果转化为临床实践，推出全球首个获批上市的神经生长因子药物金路捷，已惠及数百万患者。此外，海特生物正在推进HiTrans?平台，这是一个基于转铁蛋白受体（TfR）的脑递送平台，旨在助力治疗药物跨越血脑屏障，在中枢神经系统（CNS）疾病领域具有应用潜力。更多信息请访问：https://www.hiteckpharma.com。
关于Visara
Visara是一家临床阶段生物技术公司，致力于开发针对眼前节及眼后节疾病的新一代生物疗法。从角膜到视网膜，Visara致力于覆盖眼部疾病的全谱系，因为视力不可替代，而未被满足的临床需求巨大。Visara为NovaBridge Biosciences（纳斯达克：NBP）旗下控股眼科子公司。其管线包括用于新生血管性视网膜疾病的四价VEGF-A × ANG-2肽抗体VIS-101，以及用于神经营养性角膜炎的新一代修饰型重组人神经生长因子疗法VIS-102。
?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 long-standing expertise in nerve growth factor (NGF) therapeutics
WUHAN, China, October 13, 2026 -- 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 (NASDAQ: NBP), 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 the national reimbursement program, 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.
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.
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