ImStem Affiliate in China Receives Clinical Trial Authorization for IMS001 in Multiple Sclerosis
FARMINGTON, Conn. and ZHUHAI, China — Zhuhai Hengqin ImStem Biotechnology Co., Ltd., an affiliated company of ImStem Biotechnology, Inc., has received clinical trial authorization from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for IMS001 Injection, an investigational human embryonic stem cell-derived mesenchymal stromal cell therapy for multiple sclerosis.
The clinical trial application, under acceptance number CXSL2500514, received clinical trial implied authorization in October 2025. The authorized indications include worsening relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).
IMS001 is based on ImStem’s proprietary T-MSC platform, which generates mesenchymal stromal cells from a renewable human embryonic stem cell source through a defined developmental differentiation pathway involving a trophoblast-like intermediate. The platform is designed to provide a controlled and scalable foundation for the development of standardized, off-the-shelf cellular therapies.
The China authorization represents an important step in the continued clinical translation of the T-MSC platform and expands the clinical development of IMS001 into an additional major regulatory jurisdiction.
IMS001 previously entered clinical development in the United States following FDA authorization of the investigational program in multiple sclerosis. The ongoing U.S. study, registered as NCT04956744, is evaluating the safety, tolerability, and exploratory efficacy of IMS001 in patients with multiple sclerosis who have experienced inadequate response or intolerance to prior disease-modifying therapies.
Multiple sclerosis is a chronic immune-mediated disorder of the central nervous system that can lead to progressive neurological disability. Although disease-modifying therapies have substantially expanded treatment options, patients with progressive disease and those who respond inadequately to existing therapies continue to represent an important area of unmet medical need.
The authorization in China further advances the translation of IMS001 from a defined pluripotent stem cell differentiation platform through manufacturing and regulatory development into clinical evaluation across both the United States and China.
About IMS001
IMS001 is an investigational, allogeneic cell therapy composed of T-MSCs derived from human embryonic stem cells through a defined developmental differentiation process. Unlike conventional MSC manufacturing approaches that depend on repeated procurement of primary donor tissues, the T-MSC platform begins with a renewable pluripotent stem cell source and uses a controlled differentiation process intended to support scalable and standardized cell production.
About ImStem Biotechnology
ImStem Biotechnology, Inc. is a clinical-stage biotechnology company developing pluripotent stem cell-derived cellular therapies. Its T-MSC platform applies developmental stem cell biology to the generation of scalable, off-the-shelf cell therapy candidates, with IMS001 representing the lead clinical-stage program.
Zhuhai Hengqin ImStem Biotechnology Co., Ltd. is an independent affiliated company of ImStem Biotechnology, Inc. and is responsible for the regulatory and clinical development of IMS001 in China.