The clinical research progress of XKH004 by Xinkanghe Biotechnology was showcased at the International Conference on Ankylosing Spondylitis.

From March 30 to April 1, 2023, the 2023 International Genetic Conference on Ankylosing Spondylitis (IGAS) will be held in Naples, Italy.IGASThe conference will be held inNaples, Italy,Academician Dong Chen, founder and chief scientific advisor of Xinkanghe Biopharmaceuticals, was invited to attend and introduced the clinical trial progress of Xinkanghe Biopharmaceuticals' humanized monoclonal antibody (XKH-17).IL-17A/Fhumanized monoclonal antibody (XKH004)clinical trial progress.

IGASThe conferenceisan international medical conference on spondyloarthritis and related diseases, held every two years, covering research fields such as genetics, immunology, and translational medicine, exchanging the latest research progress in ankylosing spondylitis and other rheumatic immune diseases.

Academician Dong Chen presented a report titled"Th17cells and autoimmunity" (Th17cells and autoimmune diseases) in which he focused on the functions and regulatory mechanisms of cells and related cytokines in various immune diseases, and also discussed the results of the multicenter, randomized, double-blind, placebo-controlled phase II clinical trial of XKH004 for the treatment of ankylosing spondylitis.He highlightedTh17the functions of cells and related cytokines in various immune diseases and their regulatory mechanisms, and also shared the results of the multicenter, randomized, double-blind, placebo-controlled phase II clinical trial of XKH004 for the treatment of ankylosing spondylitis.XKH004 product in treating ankylosing spondylitis.

The project obtained the IND approval in China in February 2021 and started clinical research in the same year, enrolling a total of 140 patients and completing the first analysis of the phase II clinical study in December 2022.The phase II clinical study's first analysis successfully reached the primary clinical research endpoint.PhaseII

Due to the impact of the COVID-19 pandemic,in123 evaluable casesamongthe first analysis results showedthat the ASAS40 response rate in the experimental group was higher than that in the placebo group (based on the FAS set: 46.9~51.2% vs 25%, based on the PPS set: 51.9~60.0% vs 27.8).The experimental group showed a significant therapeutic advantage compared to the placebo group.%Based on the first analysis results,the common treatment-related adverse events and incidence rate of XKH004 were similar to those in phase I b and psoriasis clinical studies, and no new safety risks were found, demonstrating thatXKH004 has good safety and tolerability.XKH004 has shown good safety and tolerability in patients with active moderate AS and very encouraging therapeutic advantages. It has the potential to become the best antibody drug for treating AS.

In JanuaryXinkanghe has submitted the phase III clinical research plan to CDEAfter approval, the company will vigorously promote the phasea/After approval, the company will vigorously promote the phaseIIIPhaseclinical research.About Xinkanghe BiopharmaceuticalsXKH004 has shown good safety and tolerability in patients with active moderate AS and very encouraging therapeutic advantages. It has the potential to become the best antibody drug for treating AS.

Xinkanghe Biopharmaceuticals was established in2015, founded by Academician Dong Chen, a renowned immunologist, who is the director of the Shanghai Institute of Immunotherapy Innovation and a professor at Shanghai Jiao Tong University School of Medicine,and a professor at Tsinghua University School of Medicine.

2023The company is committed to international cutting-edge immunology research,focusing on the development of macromolecular drugs in the fields of autoimmune diseases and immuno-oncology, aiming to create innovative drugs with independent intellectual property rights from China for the global market.The company adheres to the research and development philosophy of "innovation, precision, quality, and focus," combining solid basic science with translational medicine, and has multiple research and development projects with global independent intellectual property rights, covering a rich range of indications in autoimmune and oncology fields.递交了Ⅲ期临床的研究方案，获批后公司将大力推进该项目的Ⅲ期临床研究。

关于鑫康合生物医药

鑫康合生物医药成立于2015年，创始人为上海市免疫治疗创新研究院院长、上海交通大学医学院教授、清华大学医学院教授、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，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。