Innovation
Huawei Hengyuan Completes China's 818 Regulatory Filing for hiSC Cell Therapy in Rheumatoid Arthritis Huawei Hengyuan (Beijing) Biomedical Technology Co., Ltd., a Tsinghua University spinoff, has completed regulatory filing under China’s State Council Decree No. 818 for a clinical study of its human induced Sertoli-like cell (hiSC) therapy for rheumatoid arthritis (RA). Registered as MR-N-45-2026-000116, the study is sponsored by Huawei Hengyuan and led by the First Affiliated Hospital of Guangxi Medical University, with participation from Handan Central Hospital. It is Guangxi’s first filing under the new framework effective May 1, 2026, and the 16th nationally. Derived from human fibroblasts using NR5A1 and GATA4 transcription factors, hiSCs have immunomodulatory properties. The study will assess the safety, tolerability, and efficacy of a single intra-articular injection in RA patients with persistent synovial inflammation despite systemic treatment.