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HL401 is an investigational cell therapy being developed by Hanlim Pharm Co., Ltd. (also known as Hallym Pharmaceutical) for the treatment of systemic lupus erythematosus (SLE). The therapy utilizes mesenchymal stem cells (MSCs), which are multipotent stromal cells recognized for their potent immunomodulatory and anti-inflammatory properties. In the context of SLE, HL401 is designed to address the underlying autoimmune dysfunction by suppressing the overactive immune response, inhibiting the proliferation and activation of T and B lymphocytes, and promoting the expansion of regulatory T cells (Tregs). By restoring immune homeostasis and reducing systemic inflammation, HL401 aims to mitigate the organ damage and clinical symptoms associated with lupus. The candidate is currently in early-stage clinical development, transitioning from preclinical evaluation into Phase 1 trials.
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