Our company's clinical registration application for umbilical cord mesenchymal stem cells has officially entered the evaluation process at the Center for Drug Evaluation (CDE) of the China Food and Drug Administration. On October 17, 2013, Beike Biotechnology Co., Ltd. submitted a clinical registration application for umbilical cord mesenchymal stem cells to the Guangdong Provincial Drug Administration, and the application was accepted by the provincial bureau. Over the following three months, the Guangdong Provincial Bureau conducted on-site registration inspections of Beike Biotechnology Co., Ltd.'s research site in Shenzhen and the contracted research sites in Guangzhou, Beijing, and Shanghai, and conducted spot-check sampling and sealing of the registration test samples to verify the authenticity of the research work. Through the joint efforts of all members of the project team, all four of the above-mentioned research sites passed the provincial bureau's inspection.
After passing the provincial bureau's inspection, the spot-check samples were delivered in early March 2014 to the National Institutes for Food and Drug Control for registration testing, with passing results. On March 14, the registration application of Beike Biotechnology Co., Ltd. officially entered the queue for review at the Center for Drug Evaluation of the National Medical Products Administration.
Since its founding in 2005, Beike Biotechnology Co., Ltd. has been committed to becoming a leader in advancing the clinical translation of biotherapy technology. From the beginning of the company, we began to establish an umbilical cord mesenchymal stem cell culture system. In 2009, we conducted systematic research on it, and following the introduction of the new stem cell policy direction in 2013, we proceeded with the registration submission. The smooth progress of this submission is due to the strong support of the company's leadership at all levels and the close cooperation of all departments. Company leaders defined the submission strategy at a strategic level, providing direction for the registration submission of this product. The R&D Department, the Preparation and Testing Departments, the Quality Management Center, and the Registration Submission Department, throughout the research and registration submission process, did not shy away from hard work and weariness, working in step and in solidarity, pouring great effort into this product and performing extensive high-intensity, high-quality work, thereby laying a solid foundation for the registration submission. Departments and leaders at all levels also performed extensive coordination work during the registration submission and on-site inspection, making indelible contributions to the registration submission of this product.
The opening up of stem cell registration submission by the National Medical Products Administration indicates that stem cell management will become increasingly standardized and regulated. High-tech enterprises with the strength to undertake R&D and registration submissions will be upgraded to pharmaceutical companies through the productization of stem cells, while small enterprises lacking strength, technology, or compliance will be eliminated as they can no longer fish in murky waters. Stem cell R&D enterprises are about to face severe polarization.
The smooth entry of this product's registration application into the National Bureau's drug evaluation process marks an important step taken by Beike Biotechnology Co., Ltd. toward stem cell product upgrading and corporate upgrading!
