Xinkanghe's First-in-Class XKH001 project has submitted an IND application for a new indication: for atopic dermatitis (AD).

Shaoxing City, Zhejiang Province, China, Beijing City,On August 15, 2024, the immuno-innovative drug development company Xinkanghe Bio announced that it has submitted its self-developed First-in-Class drug XKH001 (anti-IL-25 monoclonal antibody) for the treatment of moderate to severe atopic dermatitis (AD) patients to the National Medical Products Administration (NMPA).IIPhase clinical studyIND application.At the same time, Xinkanghe applied to the U.S. Food and Drug Administration (FDA) for the atopic dermatitis (AD) indication.IIPhase clinical trial has been scheduled.After approval by regulatory agencies in China and the U.S., XKH001 will be able to conduct Phase II clinical trials in both countries..This product is the second indication after the IND approval for asthma in China and the U.S.It has entered the clinical developmentstage.Thesecondindication.

IL-25 is a major upstream regulatory cytokine in the type 2 immune response signaling pathway, playing an important role in regulating multiple type 2 inflammatory diseases, including asthma and atopic dermatitis, providing differentiated therapeutic drugs on the pathway and currently available and in-development target products, with great development potential.

AboutXKH001

XKH001 is the world's first anti-IL-25 monoclonal antibody inhibitor independently designed and developed by Xinkanghe Bio. Research results indicate that the expression of cytokine IL-25 is significantly upregulated in various inflammatory disease tissues, participating in the pathogenic mechanisms of asthma, atopic dermatitis, and other inflammatory diseases. XKH001 aims to specifically neutralize human IL-25 by blocking its binding to receptors, inhibiting type 2 inflammatory responses.

XKH001 is the only IL-25 targeted drug that has entered clinical trials globally,while other drugs targeting the same pathway are currently in preclinical development.XKH001 for asthma indication has completed Phase Ia and Ib clinical trials in healthy individuals in China,demonstrating its safety and tolerance after single, multiple administrations,PK/PD data supports subsequent clinical development with administration once every 4 weeks.orexploring longer administration cycles,in asthma patients.Phase Ic clinical trial has completed enrollment and treatment, and is currently undergoingsafety follow-up,preliminary efficacy andPD biomarkerdatasupportingthe product's entry intoasthmaPhase clinicaltrials.IIThe companyplans to conduct Phase clinical trials in atopic dermatitis and asthma patients within the year.About Xinkanghe BioXinkanghe Bio was established inII2015, founded by internationally renowned immunologist Academician Dong Chen. The company adheres to the basis of cutting-edge international immunology research, focusing on the development of macromolecular drugs in the fields of autoimmune diseases and immuno-oncology, committed to creating innovative drugs with independent intellectual property rights originating from China for the global market, providing patients with globally pioneering or best-in-class treatment options. The company upholds the R&D philosophy of "innovation, precision, quality, and focus," combining solid basic science with translational medicine, possessing multiple globally independent intellectual property innovative pipeline products and new indications entering clinical stages. Xinkanghe will continue to delve into the unmet clinical needs in the fields of inflammation/autoinflammatory diseases and tumor immunotherapy, and looks forward to deep cooperation with innovative pharmaceutical companies at home and abroad.

关于鑫康合生物医药

鑫康合生物医药成立于2015年，创始人为国际著名免疫学家董晨院士。公司坚持以国际前沿免疫学研究为基础，专注于自身免疫性疾病和免疫肿瘤领域大分子药物的开发，致力于做源于中国，面向全球市场、具有自主知识产权的创新药物，为患者提供全球首创或者同类最佳的治疗方案。公司秉承“创新、精准、优质、专注”的研发理念，通过扎实的基础科学与转化医学相结合，拥有多个全球自主知识产权的创新管线产品和新适应症进入临床阶段，鑫康合将继续深耕在炎症/自身免疫疾病和肿瘤免疫治疗中临床需求未被满足的领域，也非常期待与国内外创新药企进行深度合作。