Huawei Hengyuan Completes China's 818 Regulatory Filing for hiSC Cell Therapy in Rheumatoid Arthritis
BEIJING — Huawei Hengyuan (Beijing) Biomedical Technology Co., Ltd., a Tsinghua University spinoff focused on regenerative medicine, has completed regulatory filing for a clinical study evaluating its hiSC cell therapy for rheumatoid arthritis under China's new biomedical technology framework.
The clinical research, titled "A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Single Intra-articular Injection of hiSC Cell Injection for Rheumatoid Arthritis," received filing number MR-N-45-2026-000116 under State Council Decree No. 818. The study is sponsored by Huawei Hengyuan, led by the First Affiliated Hospital of Guangxi Medical University, with participation from Handan Central Hospital.
The project represents Guangxi province's first filing under the new regulatory framework and the 16th nationally to complete registration for biomedical new technology clinical research under the decree that took effect May 1, 2026.
A New Regulatory Chapter
The "Regulations on Clinical Research and Clinical Translation Application of Biomedical New Technologies" established a more comprehensive pathway for biomedical innovation in China. Under the new rules, human clinical research requires prior non-clinical research foundation, and participating medical institutions must generally be Grade 3A hospitals with completed academic and ethical reviews. Filing materials must address research protocols, risk control, informed consent, and research funding, with ongoing regulatory oversight after approval.
China's National Health Commission has clarified that the new "biomedical new technology pathway" complements traditional drug and medical device pathways, requiring companies and research institutions to select appropriate clinical translation routes based on technology attributes.
For an original cell therapy, this filing signifies that accumulated basic research, cell preparation protocols, quality control systems, non-clinical evidence, and clinical research design have entered a clearer, more standardized, and traceable clinical research framework.
From Basic Discovery to Clinical Pipeline
Huawei Hengyuan's hiSC technology traces back to basic research at Tsinghua University published in the international academic journal eLife in 2019. The research team reprogrammed human fibroblasts into human induced Sertoli-like cells (hiSCs) using two key transcription factors: NR5A1 and GATA4. The study demonstrated that these cells share transcriptional characteristics and certain cellular properties with primary human Sertoli cells and exhibit immunomodulatory properties.
The company has advanced this original research toward engineering and clinical translation. The filing targets local cell therapy for rheumatoid arthritis (RA). For patients who continue to experience persistent synovial inflammation in single or limited joints after systemic treatment, finding more precise approaches to address residual local inflammation remains an active clinical challenge.
Huawei Hengyuan aims to leverage the natural local immunomodulatory characteristics of Sertoli-like cells through intra-articular injection, exploring new treatment options for this patient population.
A Differentiated Approach
From an industry perspective, hiSC represents a notably differentiated technology pathway. Historically, autoimmune disease treatment has largely centered on systemic immunosuppression or immunomodulation. Huawei Hengyuan is exploring the use of cells' inherent immunomodulatory characteristics to achieve more targeted intervention within local microenvironments.
Company Background
Founded in late 2018 in Beijing, Huawei Hengyuan is a Tsinghua University frontier life science commercialization enterprise that has secured multiple rounds of social financing. The company focuses on three major tracks: autoimmune diseases, functional cell transplantation, and assisted reproductive gametogenesis.
The company has built an innovative product matrix including RA cell injection (#RaSC), which has completed investigator-initiated trial (IIT) clinical research and is undergoing new technology filing translation — positioning it as the first local immune-exempt cell therapy product for rheumatoid arthritis. Three reproductive testing kits have completed registration clinical trials and are expected to receive market approval in 2026. The company also maintains dozens of commercially licensable clinical-grade iPSC cell lines.
Other pipeline products include immune-exempt artificial islets and an in vitro spermatogenesis system, with multiple products having passed preclinical evaluation and entered clinical trials and industrialization.
Huawei Hengyuan has been recognized as a National High-tech Enterprise, Beijing Specialized and New SME, and Zhongguancun Disruptive Technology Enterprise. The company has established deep collaborations with leading clinical institutions including Tsinghua University School of Medicine, Peking University Third Hospital, and Shanghai Changzheng Hospital.
Danlu Capital, the company's investor, noted that it focuses on innovation that "doesn't simply add a product to existing pathways, but starts from new biological mechanisms to address clinical questions that haven't been well solved."