公司介绍
朗信生物（Innostellar Biotherapeutics Co.,Ltd）
2020年成立，注册于上海张江自贸区，专注基因治疗创新药物研发制造。公司聚焦遗传性和慢性疾病基因治疗中的迫切需求，具备多管线产品研发及产业化技术开发能力，与国内外知名临床医学中心及科学家密切合作，持续提升创新能力，致力于以更高效率、更优质量开发基因治疗产品，最终推动其应用于临床实践。
公司以眼部疾病产品基因治疗为突破点，构建安全、精准的基因替代和基因编辑技术，实现基因治疗的临床应用。公司已建立多系统疾病基因治疗的研发团队和平台生产技术，两项产品已获得IND批件，均在临床试验中表现出良好的安全性和疗效趋势。用于治疗RPE65突变相关遗传性视网膜营养不良（IRD）的LX101为国内首个获得IND批件的IRD基因治疗产品，现已完成临床III期确证性研究。LX102是朗信生物布局眼科慢性病领域的核心产品，即将启动国内首个针对新生血管性年龄相关性黄斑变性（nAMD）的Ⅲ期确证性临床试验，标志着基因治疗在大适应证领域正式进入注册研究关键阶段。
ABOUT US
Innostellar Biotherapeutics Co.,Ltd
Established in 2020 and registered in Shanghai's Zhangjiang Free Trade Zone, the company specializes in the R&D and manufacturing of innovative gene therapy drugs. Focusing on urgent needs in gene therapy for hereditary and chronic diseases, it possesses multi-pipeline product development and industrialization capabilities. Through close collaboration with renowned domestic and international clinical medical centers and scientists, the company continuously enhances its innovation capacity, striving to develop gene therapy products with greater efficiency and superior quality, ultimately advancing their application in clinical practice.
The company leverages gene therapy for ocular diseases as its breakthrough point, building safe and precise gene replacement and gene editing technologies to achieve clinical application of gene therapy. The company has established R&D teams and platform production technologies for multi-system disease gene therapy. Two products have received IND approvals, both demonstrating favorable safety and efficacy trends in clinical trials. LX101, for treating RPE65 mutation-related inherited retinal dystrophy (IRD), is China's first IRD gene therapy product to obtain IND approval and has now completed a Phase III confirmatory study. LX102, Langxin Bio's core product targeting chronic ophthalmic diseases, is poised to initiate China's first Phase III confirmatory clinical trial for neovascular age-related macular degeneration (nAMD). This milestone signifies gene therapy's formal entry into the critical registration study phase for major indications.
