The national researcher meeting for the clinical trial of XKH004 for stage III ankylosing spondylitis was successfully held, and the first case has been enrolled.

At the beginning of golden autumn, the fragrance of osmanthus fills the air. The launch meeting for the clinical trial of XKH004 for ankylosing spondylitis phase III was successfully held in Shanghai on September 10, and the first subject was enrolled on September 28.

XKH004 is a recombinant anti-human IL-17A/F humanized monoclonal antibody injection developed independently by Xinkanghe Biopharmaceutical. It can simultaneously target the homodimer IL-17A-A and IL-17F-F, as well as the heterodimer IL-17A-F. XKH004 works by blocking the interaction of IL-17A and IL-17F with their downstream pathway receptors, and is used for moderate to severe plaque psoriasis, ankylosing spondylitis, and other autoimmune-related indications. This project obtained clinical trial approval for ankylosing spondylitis in 2021, completed the first analysis of phase II clinical research in 2022, and successfully achieved the primary clinical research endpoint of the trial. This phase III clinical study is led by Professor Xu Huji from the Department of Rheumatology and Immunology at Shanghai Changzheng Hospital. This marks the official entry of the project into the large sample clinical efficacy confirmation trial stage.

At the XKH004 phase III investigator meeting, Academician Dong Chen, the founder of Xinkanghe, delivered a speech. Academician Dong expressed the hope that XKH004 would become a rising star among innovative drugs, bringing hope to more patients.

Mr. Wang Yaning, CEO of Xinkanghe Biopharmaceutical, expressed gratitude to the experts for attending and introduced the development history and operational status of Xinkanghe. As the fastest progressing innovative product in Xinkanghe's product pipeline, the company has high hopes for the clinical phase III study of XKH004, hoping to actively cooperate and work closely with research institutions to promote the early market launch of innovative drugs developed independently in China.

At the meeting, Professor Zhou Ling from the Department of Rheumatology and Immunology at Shanghai Changzheng Hospital detailed the preliminary clinical development results of the XKH004 project and the specific plan for the phase III trial. Professor Wang Li from the Department of Rheumatology and Immunology at the People's Hospital of Xinjiang Uygur Autonomous Region and members of the Xinkanghe clinical project team provided detailed introductions to the scales, management systems, and project management processes involved in the study. There was a lively and thorough discussion on issues such as the clinical plan, inclusion and exclusion criteria, and implementation processes, which prepared everyone well for the subsequent trial work.

Professor Xu Huji, the Leading PI of this clinical study, stated that biological agents are a product of modern medical progress, bringing revolutionary changes to disease treatment. In the process of drug development, besides the product itself, there are many challenges in the implementation of clinical trials. As the leading unit, Shanghai Changzheng Hospital successfully completed the clinical research for the ankylosing spondylitis indications of the XKH004 project in phases Ib & II. He hopes everyone will collaborate again, strictly adhere to the management regulations of the protocol, and believes that through past accumulation and experience, the project can be smoothly advanced, ensuring the research is standardized, efficient, and of high quality, to meet the treatment needs of patients in China as soon as possible.

On September 28, the first subject of this project was enrolled and administered at Shanghai Changzheng Hospital. After the administration, the subject was observed and reported no discomfort and was discharged smoothly.