BUSAN, South Korea--(BUSINESS WIRE)--NexThera Co., Ltd. (CEO SaeGwang Park) announced that it has submitted a Phase 1/2a Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NT-101, a non-invasive eye drop treatment for wet age-related macular degeneration (wet AMD)..

韩国釜山——（商业新闻短讯）——NexThera Co.，Ltd.（首席执行官SaeGwang Park）宣布，已向美国食品和药物管理局（FDA）提交了NT-101的1/2a期研究性新药（IND）申请，NT-101是一种治疗湿性年龄相关性黄斑变性（湿性AMD）的非侵入性滴眼液。。

NT-101 is NexThera's first new drug candidate developed using its proprietary eye drop delivery platform. This innovative technology enables the safe and convenient administration of substances to the retinal tissue, eliminating the need for invasive injections into the eye.

NT-101是NexThera使用其专有滴眼液输送平台开发的第一个候选新药。这项创新技术可以安全方便地将物质注入视网膜组织，无需向眼睛进行侵入性注射。

Wet AMD is a leading cause of blindness in the elderly. Current treatments primarily rely on antibody-based therapies targeting vascular endothelial growth factor (VEGF). However, these treatments require intraocular injections, which can be uncomfortable for patients and carry risks of infection, bleeding, and retinal detachment.

湿性AMD是老年人失明的主要原因。目前的治疗主要依赖于靶向血管内皮生长因子（VEGF）的基于抗体的疗法。然而，这些治疗需要眼内注射，这可能会使患者不舒服，并有感染，出血和视网膜脱离的风险。

Long-term administration can also lead to complications such as retinal atrophy and fibrosis. Consequently, there has been a persistent demand for a safe and convenient eye drop treatment to address this unmet medical need..

长期服用也可能导致视网膜萎缩和纤维化等并发症。因此，人们一直要求安全方便的滴眼液治疗来满足这种未得到满足的医疗需求。。

NT-101 contains an endogenous peptide as an active drug substance and a carrier protein, and it has shown comparable or superior efficacy to existing antibody treatments. Notably, the carrier's action enhances ocular surface retention and improves drug delivery to the retinal tissue, surpassing the efficacy of active ingredient alone.

NT-101含有一种内源性肽作为活性药物和载体蛋白，它已显示出与现有抗体治疗相当或更好的疗效。值得注意的是，载体的作用增强了眼表滞留并改善了药物向视网膜组织的输送，超过了单独使用活性成分的功效。

While conventional treatments primarily target VEGF inhibition, which can lead to side effects, NT-101 offers dual benefits by not only suppressing angiogenesis but also protecting optic nerve cells through balanced regulation of angiogenic and anti-angiogenic factors..

虽然常规治疗主要针对VEGF抑制，这可能导致副作用，但NT-101不仅可以抑制血管生成，还可以通过平衡调节血管生成和抗血管生成因子来保护视神经细胞，从而提供双重益处。。

A NexThera representative stated, “The phase 1/2a clinical trial for NT-101 is designed to evaluate the safety and tolerability of the investigational drug in patients with wet AMD. The trial will administer low or high doses of the drug to a cohort of 30 patients twice daily (morning and evening) for 28 days.

NexThera代表表示：“NT-101的1/2a期临床试验旨在评估研究药物在湿性AMD患者中的安全性和耐受性。该试验将对30名患者进行低剂量或高剂量的药物治疗，每天两次（早上和晚上），持续28天。

Secondary objectives include monitoring changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA) following drug administration.”.

次要目标包括监测药物给药后中央亚视野厚度（CST）和最佳矫正视力（BCVA）的变化。”。

SaeGwang Park, CEO of NexThera, said, “We are confident that the NT-101 clinical trial will establish it as a groundbreaking treatment for wet AMD, paving the way for further development. We're also exploring its potential application to other retinal neovascular diseases, such as diabetic retinopathy.”.

NexThera首席执行官SaeGwang Park表示：“我们相信NT-101临床试验将使其成为湿性AMD的开创性治疗方法，为进一步发展铺平道路。我们还在探索其在其他视网膜新生血管疾病（如糖尿病视网膜病变）中的潜在应用。”。

NexThera, a biopharmaceutical research and development company founded in February 2020 utilizing platform technology, has established itself through partnerships and strategic investments. The company has forged joint development agreements with EyeGene Inc. and BMI Korea Co., Ltd., and secured a total of KRW 16.3 billion (about USD 11.8 million) in funding through various channels, including seed funding, Series A investment, and bridge round investment..

NexThera是一家利用平台技术于2020年2月成立的生物制药研发公司，通过合作伙伴关系和战略投资建立了自己的地位。该公司与EyeGene Inc.和BMI Korea Co.，Ltd.签订了联合开发协议，并通过各种渠道获得了总计163亿韩元（约1180万美元）的资金，包括种子资金、a系列投资和桥梁投资。。

For the NT-101 clinical trial, CorestemChemon Inc. conducted the toxicity assessment, with non-clinical consulting provided by QuBEST BIO Co., Ltd. And, KCRN Research, Inc. in the United States served as the clinical contract research organization (CRO). The clinical trial drug product (DP) was manufactured by BMI Korea Co., Ltd..

对于NT-101临床试验，CorestemChemon Inc.进行了毒性评估，QuBEST BIO Co.，Ltd.提供了非临床咨询，美国的KCRN Research，Inc.担任临床合同研究组织（CRO）。临床试验药品（DP）由BMI韩国有限公司生产。。

NexThera was co-founded by two medical school professors in Busan, South Korea. Leading the company is CEO SaeGwang Park, a physician-scientist (MD, PhD) and professor at College of Medicine, Inje University. Dr. Park graduated from College of Medicine, Inje University with a specialization in basic medicine and holds master's and doctoral degrees from Seoul National University Graduate School of Medicine.

NexThera由韩国釜山的两位医学院教授共同创立。领导该公司的是首席执行官SaeGwang Park，他是Inje大学医学院的医学博士和教授。Park博士毕业于Inje大学医学院，主修基础医学，拥有首尔国立大学医学研究生院的硕士和博士学位。

He also has research experience at the University of Chicago in the United States..

他还拥有美国芝加哥大学的研究经验。。

Jee-Yeong Jeong (PhD), NexThera's co-founder and CTO, boasts an impressive background in biotechnology. After earning bachelor's and master's degrees in biochemistry from Yonsei University, he began his career at LG Chem's renowned Biotech Research Institute, a breeding ground for Korean biotech startups.

Jee Yeong Jeong（博士），NexThera的联合创始人兼首席技术官，拥有令人印象深刻的生物技术背景。在延世大学获得生物化学学士和硕士学位后，他在LG化学著名的生物技术研究所开始了职业生涯，该研究所是韩国生物技术初创公司的温床。

Dr. Jeong then went on to complete his doctorate at Purdue University in the United States. He has also served as an instructor at Harvard Medical School and currently holds a professorship at Kosin University College of Medicine..

然后，Jeong博士在美国普渡大学完成了博士学位。他还曾担任哈佛医学院的讲师，目前在科辛大学医学院担任教授。。

NexThera is dedicated to developing advanced treatments and platforms that leverage the unique strengths of its co-founders, drawing on their combined experience and achievements in biomedical research spanning over 20 years. In addition to NT-101, ongoing projects include advancing a biobetter development platform and cancer cell-selective protein synthesis inhibition technology.

NexThera致力于开发先进的治疗方法和平台，利用其联合创始人的独特优势，利用他们在20多年的生物医学研究中的综合经验和成就。除NT-101外，正在进行的项目还包括推进biobetter开发平台和癌细胞选择性蛋白质合成抑制技术。

The biobetter development platform, which utilizes the properties of self-assembling proteins, is a versatile system applicable to the development of various protein drugs and biobetters, including peptides, enzymes, and antibody fragments. This platform is currently undergoing optimization following the completion of patent applications and the selection of application candidates.

利用自组装蛋白质特性的biobetter开发平台是一个多功能系统，适用于开发各种蛋白质药物和生物制剂，包括肽，酶和抗体片段。随着专利申请的完成和候选申请的选择，该平台目前正在进行优化。

Additionally, the technology for selectively inhibiting protein synthesis in cancer cells has been chosen by the 2023 Korea Drug Development Fund to receive government subsidies for research due to its innovation and practicality. Research and development efforts are currently focused on successfully identifying lead compounds..

此外，2023年韩国药物开发基金（Korea Drug Development Fund）选择了选择性抑制癌细胞蛋白质合成的技术，由于其创新性和实用性，该技术可获得政府的研究补贴。目前，研究和开发工作的重点是成功识别先导化合物。。

To optimize its research and development activities, NexThera has established a dedicated R&D center staffed with a team of highly qualified researchers. The company recently bolstered its team with clinical development experts and biopharmaceutical manufacturing process specialists, all boasting extensive IND experience.

为了优化其研发活动，NexThera建立了一个专门的研发中心，配备了一支高素质的研究人员团队。该公司最近通过临床开发专家和生物制药制造过程专家加强了团队，他们都拥有丰富的IND经验。

This strategic expansion will accelerate NexThera's development and commercialization efforts..

这一战略扩张将加速NexThera的开发和商业化努力。。