First in class, Xinkanghe antibody drug XKH001 has been approved by the US FDA to enter clinical trials.

Beijing, China, Suzhou, Jiangsu,2021Year07Month29Day- China Immunology Innovative Drug Development Company Xinkanghe Biopharmaceutical announced today that the company has received notification from the US FDA, agreeing to its innovative drug XKH001 for the treatment of inflammatory and allergic diseases to enter clinical trials. This is the first FDA-approved product of the Xinkanghe team. The product also received feedback from the National Medical Products Administration regarding its pre-IND application in early July.pre-IND applicationfeedback.,Looking forwardto obtaining domestic clinical trial approval in the near future..

       XKH001It is the first monoclonal antibody inhibitor designed and developed by Xinkanghe Biopharmaceutical with global intellectual property rights.IL-25(First in Class).IL-25, also known as IL-17E, is a member of the IL-17 family of cytokines, mainly produced by epithelial cells and innate immune cells. IL-25andits binding receptor activatetype 2 immune cells, thereby initiating, amplifying, and maintaining Th2 immune responses.A large number of research results indicate that inhibitingIL-25can reduceTh2effects includingTh2cytokines such asIL-4,IL-5andIL-13expression, thus serving as a treatment fortype 2 inflammatory diseases, such as allergic asthma, chronic sinusitis,atopicdermatitis and other new drugs. Currently, all drugs targetingIL-25are still in the preclinical development stage and have not yet entered clinical research.XKH001Research results have demonstrated its good efficacy, pharmacokinetic characteristics, and safety, making it the firstFDA-approvedIL-25inhibitor to enter clinical trials.

"XKH001Obtaining FDA approval for clinical trials in the United States is an important milestone in the company's global R&D strategy and has significant implications for the company's development," said Mr. Wang Yaning, CEO of Xinkanghe Biopharmaceutical. "This drug will provide a new effective treatment for patients with refractory or resistant inflammatory and allergic diseases worldwide. We will accelerate the clinical development of XKH001 to meet the needs of patients as soon as possible."The founder of Xinkanghe Science and the director of the Shanghai Institute of Innovative Immunotherapy, Academician Dong Chen, also believes that

"The entry of XKH001 into clinical research indicates that the innovative R&D capabilities of Chinese pharmaceutical companies are rapidly improving, and global FIC products are entering the fast lane."As a Chinese original drug R&D company, Xinkanghe Biopharmaceutical has been deeply engaged in the treatment of immune diseases for many years,

and is an important part of the company's product line. Currently, another originalXKH001monoclonal antibody drug is undergoing clinical research for multiple indications.IL-17A/FThe development of other innovative pipelines is also accelerating.Ib/IIAbout

Xinkanghe Biopharmaceutical is the first globally designed and developed anti- XKH001

       XKH001monoclonal antibody inhibitor. Research results show that the expression of cytokineIL-25is significantly upregulated inIL-25type 2 inflammatory disease tissues, participating in the pathogenic mechanisms of allergic asthma, atopicdermatitis and other inflammatory diseases.XKH001 aims to specifically neutralize human IL-25 by blocking its binding to receptors, inhibiting the inflammation caused by Th2.Currently, all drugs targetingare still in the preclinical development stage, and no drugs have entered clinical trials.Plans to conduct clinicalIL-25Phase I clinical trials in China and the United States.XKH001About Xinkanghe BiopharmaceuticalXinkanghe Biopharmaceutical was established in

2015, founded by Academician Dong Chen, director of the Shanghai Institute of Innovative Immunotherapy and professor at Tsinghua University School of Medicine, an internationally renowned immunologist. 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 being sourced from China,targeting the global,market, with independent intellectual property rights for innovative drugs, providing patients with globally pioneering or best-in-class treatment options.The company adheres to the R&D philosophy of "innovation, precision, quality, and focus," combining solid basic science with translational medicine, and has multiple R&D projects with global independent intellectual property rights, covering a rich range of indications in the fields of autoimmune diseases and tumors.、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，已拥有多个拥有全球自主知识产权的研发项目，产品管线在自身免疫与肿瘤领域覆盖丰富的适应症。