• On December 24, 2024, the NP001 product independently developed by Shanghai Saierxin Biomedical Technology Co., Ltd. (referred to as "NOVABIOTX") completed the first dosing of a patient with Amyotrophic Lateral Sclerosis (commonly known as ALS or Lou Gehrig's disease) at the First Affiliated Hospital of Zhengzhou University. Currently, the subject’s indicators and tolerability are good.
• NOVABIOTX was incubated under the leadership of Hua Capital and received its angel round investment led by Hua Capital in 2023.
Healthcare Professionals and Patients from the First Affiliated Hospital of Zhengzhou University Participating in ALS Clinical Research Take a Group PhotoNP001 is an autologous polyclonal Treg cell injection derived from high-purity Treg cells enriched from the patient's peripheral blood. After in vitro expansion to a sufficient clinical dose, it is reinfused into the patient. Leveraging the immunomodulatory and tissue repair functions of Treg cells, it is expected to play a positive therapeutic role in autoimmune diseases and neurodegenerative diseases (NDD) and related conditions.This is the world's first case of intrathecal injection of Treg cells for the treatment of ALS. Compared with intravenous administration, intrathecal injection allows therapeutic Treg cells to directly reach the affected area. According to the researchers' feedback, the administration process of the NP001 product went smoothly. Currently, the patient is in stable condition without any adverse reactions, and subsequent re-infusions will be conducted every 4 weeks.Early clinical data showed that intravenous infusion of Treg cells for ALS treatment tended to reduce the decline in ALSFRS-R scores and could delay disease progression (S.H. Appellate, 2022). Intrathecal injection of cell therapy demonstrated a better trend in efficacy compared to intravenous treatment (S.M. Nabavi, 2018). To date, both preclinical and clinical data have indicated that Treg cells possess favorable safety.Latest Clinical Efficacy of Intrathecal Injection Therapy with Treg CellsThe first patient receiving the NP001 product was diagnosed with ALS at the end of March 2024. Before administration, the patient showed a significant decline in the ALSFRS-R score and had gradually developed symptoms such as mobility difficulties and limb weakness. This study will comprehensively evaluate Treg cell therapy for ALS through clinical observations, ALSFRS-R scoring, cytokine analysis, and single-cell sequencing, further elucidating its therapeutic mechanism in the hope of providing a more effective treatment option for ALS patients.Group photo of the patient with medical staff during the first drug administration and after administration
About NOVABIOTX
Shanghai Saierxin Biomedical Technology Co., Ltd. (NOVABIOTX) began operations in early 2023, focusing on the development of multi-modal Treg cell therapies for treating neurodegenerative diseases, autoimmune diseases, and metabolic disorders. After years of research, it was discovered that Treg can effectively suppress the proliferation and function of pro-inflammatory cells in autoimmune diseases from multiple angles, achieving therapeutic effects. Adhering to its core mission of "addressing unmet clinical needs," and upholding the core values of "patient-centeredness, integrity, diligence, and perseverance," NOVABIOTX leads the industrial development of Treg therapies. Recently, NOVABIOTX collaborated with Haier International Cell Bank, Yingkang Life, and Cai Lei and his team to discuss comprehensive ALS therapy solutions, reaching a consensus to integrate existing treatment concepts and promote them to clinical applications as soon as possible to improve the current state of ALS treatment. NOVABIOTX has received positive Pre-IND feedback from the National Medical Products Administration (NMPA) and the FDA, with plans to complete dual IND submissions in China and the U.S. by early next year. Clinical trials will be conducted under the FDA-certified Orphan Drug Designation (ODD) pathway, and patients from Europe, the U.S., and other regions have already contacted NOVABIOTX to register for participation.--End--
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Hua Gai Capital was founded in 2012 by a group of professionals from well-known investment institutions in and outside China. With the vision of "becoming the most trusted capital partner for entrepreneurs and investors," the company focuses on private equity investments in the two major fields of healthcare and technology, and is committed to promoting the growth of small and medium-sized enterprises into industry leaders. Currently, the company manages assets exceeding 20 billion RMB.
