Authoritative certification: aCGT obtained three " Inspection Report " from the National Institutes for Food and Drug Control

As we all know, stem cell products are medical products, and their safety and effectiveness are the top priorities. Since its establishment, aCGT has always adhered to the principle of "safe and effective, scientific basis, compliance and legality", and has been striving for excellence in cell quality control, laying a solid foundation for the clinical transformation and application of the company's stem cell technology and products and investigational new drug application .

aCGT passed the review and verification of the National Institute for Food and Drug Control (hereinafter referred to as the "National Institute for Food and Drug Control") and officially obtained the following " Inspection Report " (SH202003392, SH202003393，SH202003394).

The National Institute for Food and Drug Control is the national statutory institution and the highest technical arbitration institution for testing the quality of pharmaceutical biological products, a national testing laboratory with laboratory accreditation (CNAS) and qualification accreditation (CMA) qualifications, and the only legal institution in China that can issue stem cell quality verification reports. Through the comprehensive testing of the product's libraries at all levels and the final product preparation, combined with the company's self-built testing methods and the proposed quality standards, the "Inspection Report" was issued.

The human umbilical cord is derived from the mesoderm and ectoderm in the early stage of development, and has a high degree of proliferative ability, multi-directional differentiation ability and immunomodulatory effect, which can be used to treat autoimmune diseases such as lupus erythematosus and scleroderma, and co-transplantation with hematopoietic stem cells can significantly improve the treatment effect of leukemia and refractory anemia. It also has good curative effects on bone and muscle degenerative diseases, cardiovascular and cerebrovascular diseases, liver diseases, brain and spinal cord nerve injuries, and Alzheimer's disease.

Since the end of 2017, the CDE has begun to accept stem cell products for drug access to investigational new drug (IND), and the testing methods and testing standards for stem cell quality have received extensive attention from the industry. However, due to the new concept of stem cell technology and the particularity of biological agents, research institutions and practitioners lack quality reference and flaunting for a while, the Central Institute for Inspection and Inspection quickly established various inspection items and evaluation standards, and took the lead in participating in the introduction of a number of guidance documents, so that this emerging industry has standardized quality standards.

aCGT strictly follows the Administrative Measures for Clinical Research of Stem Cells, the Administrative Measures for Clinical Research and Translational Application of Somatic Cell Therapy (Trial) Draft for Comments, and the Technical Guidelines for Research and Evaluation of Cell Therapy Products，and support the clinical translation of stem cell technology.

At present, the regulations stipulate that the stem cell products used in the human stem cell project shall obtain the quality inspection reports issued by a third-party testing agency, and the National Institutes for Food and Drug Control is the statutory body responsible for inspecting the quality of pharmaceutical and biological products in the country.

The successful acquisition of the inspection reports marks that aCGT has been recognized by the national authority in the preparation process and quality control of umbilical cord mesenchymal stem cell products.

At present, aCGT has established an independent production base for clinical grade cell preparations that meets GMP standards, and Established a production quality management system for cell preparations that complies with GMP standards.

aCGT insists on making efforts for the cell biomedical industry, fulfilling its corporate responsibilities for the country's great health cause.