Beike seeks approval of stem cell treatment for lupus

SHENZHEN, China – Beike Biotechnology Co., Ltd. has taken another step in the approval process for the use of human umbilical cord-derived mesenchymal stem cells (MSCs) for the treatment of systemic lupus erythamatosus (SLE), an the autoimmune disease in which the body's immune system mistakenly attacks healthy tissue. The application to register their MSCs has been officially acknowledged by the Chinese Food and Drug Administration, China's leading biotechnology company said on Thursday.

After a recent clinical study was published in Arthritis Research and Therapy showing the mesenchymal stem cells effective in treating SLE, Beike moved to apply for government approval for regular use.

Beike, world's largest stem cell provider, submitted the Investigational New Drug (NID) application to register their MSCs for clinical use to the Guangdong Province Food and Drug Administration on October 17, 2013, and was accepted.

For three months the Guangdong Food and Drug Administration carried on-site inspections for Beike's Shenzhen research sites and research facilities in Guangzhou, Beijing, and Shanghai, and all four research sites passed the inspection. The Guangdong FDA also evaluated the registered testing samples to inspect authenticity of Beike's research work.

Following inspection, testing samples were delivered to National Institutes for Food and Drug Control for registration tests early this March. The results qualified and on March 14, the NID application for registration of Beike Biotechnology's stem cells officially entered the Drug Review Center in China Drug and Food Administration queue for review.

The company is hoping for final approval of the IND application treat SLE with mesenchymal cells before year-end. Dr. Sean Hu, Beike chairman and founder, is pleased and optimistic that the approval process will go as smoothly. “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,” he said.

The application process 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, Dr. Hu also said.