SHENZHEN, China, July 10, 2014 /PRNewswire/ -- Beike Biotechnology Co., Ltd. (Beike) has officially been accepted into the approval process for the Chinese Food and Drug Administration for the use of human umbilical cord (UC) derived mesenchymal stem cells (MSCs) for clinical translation and treatment of Systemic Lupus Erythamatosus (SLE). After a recent clinical study was published showing Beike's mesenchymal stem cells effective in treating SLE (http://arthritis-research.com/content/pdf/ar4520.pdf), Beike Biotechnology moved to apply for government approval for regular use.
Beike submitted the Investigational New Drug (IND) application to register their UC MSCs for clinical use to the Guangdong Province Food and Drug Administration on October 17th, 2013 and was accepted.
For three months the Guangdong Food and Drug Administration (Guangdong FDA) carried on-site inspections for Beike's Shenzhen research sites as well as entrusted research facilities in Guangzhou, Beijing, and Shanghai. The administration also evaluated the registered testing samples to inspect authenticity of Beike's research work. With joint efforts from all members in the project group, Beike's four research sites above all passed the inspection of the Guangdong FDA smoothly.
After being inspected by the Guangdong FDA, testing samples were delivered to National Institutes for Food and Drug Control for registration tests in early March, 2014. The results qualified and on March 14, the IND application for registration of Beike Biotechnology's stem cells officially entered the Drug Review Center in China's Drug and Food Administration queue for review.
Dr. Sean Hu, Beike Chairman and founder, was very pleased and optimistic. "Beike's research and safety accreditation is well documented. However without government approval it doesn't mean much to the public who is need of this technology. While only in the application process, it is a critical step forward towards the regulation and control of stem cell technology in order to provide safe and ethical medical options to the world. Cooperation is vital in today's ever-changing technological world, and Beike Biotech hopes that more companies and governments will move in the same direction of regulation and approval."
Beike Biotech has a long history of government cooperation and accreditation. Beike Biotechnology has established more than 20 adult stem cell processing laboratories in accordance with GMP standards and has been awarded ISO9001 and ISO17025 certificates. Beike's Jiangsu inspection center was accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2011, and it is the first adult stem cell processing laboratory accredited by CNAS. Beike Biotechnology also successfully completed on-site evaluation for American Association of Blood Bank (AABB) accreditation in September 2011.
Beike Biotechnology is hoping for final approval of the IND application before the end of the year. If it is successful, Beike would then be able to treat SLE with mesenchymal cells regularly with government support.
About Beike Biotechnology Company:
Beike Biotechnology Co., Ltd. (www.beikebiotech.com) is the world's largest stem cell provider and China's leading biotechnology company focusing on the production of adult stem cells for use in medical therapies. Headquartered in Shenzhen (near Hong Kong) with a flagship regenerative medicine facility at the China Medical City in Jiangsu province, Beike produces a full line of stem cell products derived from umbilical cord, cord blood, and autologous bone marrow.
