Shenji Changhua AAV Gene Therapy Drug SNUG01 Completed the First Subject Administration in the Third Hospital of Beijing Medical University

Recently, the AAV gene therapy drug SNUG01 for amyotrophic lateral sclerosis (also known as ALS) in Shenji Changhua was administered to the first domestic subject in IIT research by Professor Fan Dongsheng's team from Peking University Third Hospital (hereinafter referred to as "North Third Hospital").

Following the first attempt of sympathetic administration of AAV gene therapy for asymptomatic frostbite in China, SNUG01 launched a clinical study (IIT) initiated by researchers in the Third Hospital of North Medical College on September 22. The full name of the project is "A single-arm, open exploratory clinical study to evaluate SNUG01 single intrathecal injection in patients with amyotrophic lateral sclerosis". It was initiated by Professor Fan Dongsheng, a famous expert on ALS, as the main researcher and funded by Shenji Changhua.

Before the administration of the subject, Professor Fan Dongsheng's team, Shenji Changhua's team and Tsinghua University Jia Yichang's laboratory team worked closely to ensure that the research was carried out in accordance with the clinical research plan specifications, with strict inclusion, scientific inclusion, full communication with the subject, and rigorous and perfect preparation before administration. In order to ensure the high-quality implementation of clinical trials, the drug clinical trial institution of the Third Hospital of North Medical College conducted quality control on the project before the first subject was administered, and sorted out the test process and operation details with the researchers and Shenji Changhua team again. At present, the first subject has reached 3 weeks after administration, the overall state is stable, and no serious adverse events have been observed. The research team held a safety review meeting according to the clinical trial plan to discuss the follow-up work. Li Haiyan, director of the drug clinical trial institution of the Third Hospital of North Medical College, Xu Yan, and Dr. Peng Lin and Dr. Guo Wei, co-founders of Shenji Changhua, participated in the meeting online.

Professor Fan Dongsheng to check the patient's situation after administration

safety review meeting

North Medical University said, "The first subject of this IIT study has been successfully administered. The subject is in good condition after administration and we will continue to monitor the subject's post-treatment condition. We have been working closely with the Shenji Changhua team and Tsinghua University Jia Yichang Laboratory to develop innovative drugs for neurodegenerative diseases and hope that our research work will benefit more patients as soon as possible."

Shenji Changhua Science and professor of medicine at Tsinghua University, said, "First of all, I would like to express my sincere gratitude to Professor Fan Dongsheng's team at the Third Hospital of Beijing Medical University for their strong support for this IIT research. SNUG01 can make such rapid progress in research and development, thanks to Shenji Changhua's capable and experienced R & D team and efficient and professional clinical operation team, as well as the strong support from all sectors of the community."