On April 28, 2024, the innovative cell drug “Human Umbilical Cord Mesenchymal Stem Cell Injection” (acceptance number: CXSL2400092) independently developed by Beike Biotech for the treatment of moderate to severe systemic lupus erythematosus received a drug clinical trial approval notice (notification number: 2024LP01052) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) three working days in advance. This innovative achievement marks that China’s first mesenchymal stem cell drug for the treatment of moderate to severe systemic lupus erythematosus is about to enter the clinical trial stage.
Systemic Lupus Erythematosus (SLE) is an autoimmune disease involving multiple organs and systems throughout the body. It is characterized by immune cell activation and the production of a large number of autoantibodies, and is potentially related to genetics, environment, and estrogen. Currently, glucocorticoids and immunosuppressants are the main treatment options for SLE, but most patients are difficult to achieve clinical remission and have a high mortality rate. Finding a more optimized SLE treatment strategy is still an urgent problem that needs to be solved [1]. Mesenchymal stem cells (MSC) are adult stem cells derived from early developmental mesoderm. They have high proliferation, self-renewal capabilities, multi-directional differentiation potential, damaged tissue repair function and immunosuppressive capabilities. Studies have shown that MSC can inhibit systemic lupus erythematosus (SLE) activity and differentiate into multiple cells by regulating immune cells, repairing multi-system and multi-organ damage caused by SLE, which has been a hot research topic in recent years [2].
The new stem cell drug “Human Umbilical Cord Mesenchymal Stem Cell Injection” submitted by Beike Biotech this time is a stem cell preparation independently developed by Beike Biotech and is intended to be clinically used to treat moderate to severe systemic lupus erythematosus.
Beike Biotech has been deeply involved in the field of cells for nearly 19 years. Since 2009, it has comprehensively launched systematic research and new drug development on mesenchymal stem cells. So far, the company has accumulated more than 10 years of process development, quality research and stability data. During this period, Beike Biotech completed a number of drug efficacy, pharmacological studies and safety studies in in vitro models, and cooperated with many hospitals to conduct IIT clinical research. The company has not only achieved clinical-grade, standardized and large-scale stem cell production and preparation, but has also passed the comprehensive quality inspection by the China Institute of Food and Drug Control (hereinafter referred to as “China Institute for Food and Drug Control”). Under the guidance of the latest Technical Guiding Principles for Pharmaceutical Research and Evaluation (Trial) and relevant GMP guidelines, Beike Biotech has carried out a comprehensive production process upgrade for the new stem cell drug submitted this time, including the optimization of serum-free and xeno-free culture systems, closed large-scale operations, etc. At the same time, the company has developed a series of comprehensive testing methods closely related to cell safety and effectiveness, and has successfully developed industry-leading next-generation stem cell preparation technology, and has applied for and been approved for a number of invention patents.
As a national high-tech enterprise specializing in the clinical transformation and technical services of biotherapeutic technologies in strategic emerging industries, Beike Biotech has always insisted on promoting the transformation of innovative scientific and technological achievements as an important driving force for corporate development. It has created multiple innovative R&D platforms and R&D pipelines and is advancing at full speed. In the future, Beike Biotech will continue to promote the research and development of new drugs, apply for new stem cell drugs for more indications such as autoimmune diseases, accelerate the transformation and clinical application of related technology products, create more innovative products and solutions with independent intellectual property rights, and make unremitting efforts to improve human health.
References:
[1] Yang Chunjuan, Yang Jinghan, Zhang Lili, etc. Immunomodulatory effects and applications of mesenchymal stem cells in systemic lupus erythematosus [J]. Chinese Journal of Clinical Immunology and Allergy, 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 University, 2020, 41(05): 363-365.DOI: 10.13845/j.cnki.issn1673-2995.2020.05.020.