Hode Biotech Completes First-in-Human Dosing in Pivotal Phase I Clinical Trial of hNPC01 Injection for Ischemic Stroke-Induced Hemiplegia

Recently, the Phase I registration clinical trial initiated by Hopstem Biotechnology as the sponsor, titled “A Dose-Escalation, Single-Center, Open-Label Clinical Study to Evaluate the Safety and Tolerability of Human Induced Pluripotent Stem Cell-Derived Forebrain Neural Progenitor Cell Injection (hNPC01 Injection) in Improving Hemiplegic Sequelae of Ischemic Stroke,” has successfully completed the first subject dosing and 21-day observation period by Professor Yang Zhiquan’s team at Xiangya Hospital. The first enrolled subject received the initial dose of hNPC01 injection on December 7 and remained stable with normal indicators, no surgical or perioperative complications, and was discharged smoothly three days post-procedure to continue rehabilitation exercises. Currently, three weeks have passed since the first subject’s dosing; the overall condition remains stable, with self-reported improvement in muscle strength. The research team conducted a safety review meeting in accordance with the clinical trial protocol. Meanwhile, the second and third patients have been enrolled and completed preliminary observations, and are scheduled to receive dosing as planned.

In late June 2023, hNPC01, an injection of forebrain neural precursor cells derived from human induced pluripotent stem cells (hiPSCs), for the treatment of hemiplegic sequelae of ischemic stroke, received implicit approval for clinical trials from the Center for Drug Evaluation (CDE). This is the first pluripotent stem cell-derived forebrain neural precursor cell product globally to enter registrational clinical trials, and also the first pluripotent stem cell-derived neural cell product in China to receive Investigational New Drug (IND) approval and complete the first dose administration in registrational clinical trials.

Professor Yang Zhiquan, Xiangya Hospital“The first subject in this clinical trial has successfully received the initial dose. Three weeks post-administration, the subject is in good condition, with preliminary indications of improved muscle strength. We will continue to monitor the subject’s post-treatment status in accordance with the clinical trial protocol. Both our team and Hopstem Biotechnology share a strong spirit of collaboration and common goals, aiming to accelerate the availability of these innovative therapies to benefit more patients with hemiplegia who currently have no effective treatment options.”

Dr. Fan Jing, Founder of Hopstem Biotechnology“The collaboration has allowed us to fully appreciate the strong support and high level of professionalism demonstrated by Professor Yang Zhiquan’s team at Xiangya Hospital, the clinical trial institution, and our CRO partners in this registered clinical trial. We are also deeply grateful to the clinical volunteers for their trust and support. The enrollment applications and screening data clearly reflect the large population of stroke patients with hemiplegia and their strong willingness to receive treatment. The Company is confident in completing enrollment and dosing across all dose cohorts as planned. We will continue to leverage the efforts of our internal and external partners, driving high-quality preliminary safety clinical studies in cerebral ischemia with strong execution, aiming to ultimately provide truly safe, effective, and affordable treatments for patients suffering from hemiplegic sequelae due to intracerebral hemorrhage and cerebral infarction through subsequent confirmatory clinical trials.”