On April 28, 2024, Beike Biotech's in-house developed innovative cell drug "Human Umbilical Cord Mesenchymal Stem Cell Injection" for the treatment of moderate-to-severe systemic lupus erythematosus (acceptance number: CXSL2400092) received the Drug Clinical Trial Approval Notice (notice no.: 2024LP01052) three working days ahead of schedule from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This innovation milestone marks the first domestic mesenchymal stem cell drug for the treatment of moderate-to-severe systemic lupus erythematosus that is about to enter the clinical trial stage.
Systemic Lupus Erythematosus (SLE) is an autoimmune disease involving multiple organs and systems throughout the body, characterized by activation of immune cells and the production of large quantities of autoantibodies, with potential links to genetics, environment, and estrogen. Currently, glucocorticoids and immunosuppressants are the mainstays of SLE treatment, but most patients have difficulty achieving clinical remission and the case fatality rate is high. Identifying more optimal SLE treatment strategies remains an urgent challenge[1]. Mesenchymal stem cells (MSCs) are adult stem cells derived from the early developmental mesoderm, with strong proliferative and self-renewal abilities, multilineage differentiation potential, the ability to repair damaged tissues, and immunosuppressive capacity. Studies have shown that MSCs can suppress SLE activity by regulating immune cells and differentiate into multiple cell types to repair the multi-system, multi-organ damage caused by SLE — making them a hot topic of research in recent years[2].
The stem cell new drug "Human Umbilical Cord Mesenchymal Stem Cell Injection" submitted by Beike Biotech this time is a stem cell preparation independently developed by Beike Biotech, intended for clinical use in the treatment of moderate-to-severe systemic lupus erythematosus.
Building on nearly 19 years of deep engagement in the cell field, Beike Biotech has, since 2009, comprehensively launched systematic research on mesenchymal stem cells and new drug development. To date, the company has accumulated more than 10 years of process development, quality research, and stability data. During this period, Beike Biotech has completed pharmacodynamic, pharmacological, and safety studies in multiple in vitro models, and conducted IIT clinical research in cooperation with numerous hospitals. The company has achieved clinical-grade, standardized, and large-scale stem cell production, with full quality testing passed by the National Institutes for Food and Drug Control (NIFDC). Guided by the latest pharmaceutical research and evaluation technical guiding principles (Trial) and related GMP guidelines, Beike Biotech has comprehensively upgraded the manufacturing process for the stem cell new drug submitted in this filing, including optimizing the serum-free and xeno-free culture system and the closed, large-scale operation. The company has also developed a series of comprehensive testing methods closely related to cell safety and efficacy, and has successfully developed industry-leading next-generation stem cell preparation technologies, with multiple invention patents filed and granted.
As a national high-tech enterprise specializing in the clinical translation and technical services of biotherapy technologies in strategic emerging industries, Beike Biotech has consistently regarded the translation of innovative scientific and technological achievements as an important driver of the company's development. Multiple innovative R&D platforms and R&D pipelines have been established and are advancing at full speed. In the future, Beike Biotech will continue to advance new drug R&D, file applications for stem cell new drugs in more indications such as autoimmune diseases, accelerate the translation and clinical application of related technology products, create more innovative products and solutions with proprietary intellectual property, and make tireless efforts to improve human health.
References:
[1] Yang Chunjuan, Yang Jinghan, Zhang Lili, et al. Immunoregulatory effects and applications of mesenchymal stem cells in systemic lupus erythematosus [J]. Chinese Journal of Allergy and Clinical Immunology, 2021, 15(06):684-689.
[2] Gong Xiaofan, He Ying, Fang Minghong, et al. Research progress of mesenchymal stem cells in the treatment of systemic lupus erythematosus [J]. Journal of Jilin Medical College, 2020, 41(05):363-365. DOI:10.13845/j.cnki.issn1673-2995.2020.05.020.
