Our company’s clinical registration application for umbilical cord mesenchymal stem cells has officially entered the Drug Evaluation Center of the State Food and Drug Administration to begin the review process. Beike Biotechnology Co., Ltd. submitted an application for clinical registration of umbilical cord mesenchymal stem cells to the Guangdong Provincial Food and Drug Administration on October 17, 2013, and the application was accepted by the provincial bureau. In the following three months, the Guangdong Provincial Bureau conducted registration on-site inspections at the Shenzhen research site of Beike Biotechnology Co., Ltd., as well as the commissioned research sites in Guangzhou, Beijing and Shanghai, and randomly inspected and sealed the registered inspection samples to verify the authenticity of the research work. Through the joint efforts of all members of the project team, our above four research sites have successfully passed the verification of the provincial bureau.
After passing the verification of the provincial bureau, the random inspection samples were sent to the China Institute of Pharmaceutical and Biological Products for registration inspection in early March 2014, and the inspection results were qualified. On March 14, the registration application of Beike Biotechnology Co., Ltd. officially entered the Drug Evaluation Center of the State Food and Drug Administration and began to queue up for review.
Beike Biotechnology Co., Ltd. has been committed to becoming a leading company in promoting the clinical transformation of biotherapeutic technology since its establishment in 2005. It has established an umbilical cord mesenchymal stem cell culture system since its establishment, conducted systematic research on it in 2009, and applied for registration after the introduction of new stem cell policy directions in 2013. The smooth progress of this application was due to the strong support of leaders at all levels of the company and the full cooperation of all departments: the company leaders determined the application strategy of this product from a high position and pointed out the direction for the registration application of this product; the R&D department, preparation and testing department, quality control center and registration application department were not afraid of hardships in the research and registration application process of this product. , do not complain, work in unison, unite and cooperate, devote a lot of effort to this product, do a lot of high-intensity, high-quality work, laying a solid foundation for the registration and application of this product; departments and leaders at all levels have done a lot of coordination work in the process of registration and application for this product and on-site verification, and have made an indelible contribution to the registration and application of this product.
The State Food and Drug Administration has liberalized the registration and application of stem cells, indicating that the management of stem cells will become increasingly standardized and regularized. High-tech enterprises with the strength to conduct research and development and registration applications will be upgraded to pharmaceutical companies through the commercialization of stem cells. Small businesses without strength, technology, and non-standardization will be eliminated because they can no longer fish in troubled waters. Stem cell R&D enterprises are about to face serious polarization.
The registration application for this product has successfully entered the national drug review process, marking that Beike Biotechnology Co., Ltd. has taken an important step towards stem cell product upgrade and enterprise upgrade!
