HONG KONG, Feb. 7, 2018 /PRNewswire/ — Golden Meditech Holdings Limited (SEHK stock code: 00801) ("Golden Meditech"), a leading integrated healthcare enterprise in China, announces that its associate, Cellenkos, Inc. ("Cellenkos") successfully registered its stand-alone, manufacturing facility as good manufacturing practice ("GMP") compliant with United States Food and Drug Administration ("FDA"). Cellenkos is a clinical-stage biotechnology company focused on developing universal donor cell therapeutics derived from cord blood for the treatment of autoimmune diseases and inflammatory conditions.
Cellenkos manufacturing facility ("CMF") manufactures cord blood-derived Regulatory T-cell ("Treg") therapeutics. Located in Houston, Texas, CMF covers 2,000 square feet and includes a Class 10,000 (corresponding to International Organization for Standardization 7) cleanroom with gown-in/gown-out anteroom where all major equipment will remain under continuous monitoring with off-site data backup.
"FDA registration of our manufacturing facility is an important milestone as we prepare to enter company-sponsored clinical trials," commented Chief Medical Officer, Simrit Parmar, MD. "Control over the manufacturing processes in our own facility will ensure that we are able to comply with cGMP requirements for biologics, drugs and pharmaceuticals as set out in the Code of Federal Regulations Title 21 and confirm that all manufacturing is accomplished with the highest level of safety, competence and proficiency as expected by the FDA and our clinical investigators."
All preclinical research and development, as well as clinical manufacturing and packaging of clinical product will take place at CMF. It is anticipated that CMF will have the capacity to supply sufficient quantities of Cellenkos’ lead cellular therapy candidate, CK0801, for all company-sponsored clinical trials. Cellenkos plans to initiate Phase 1 study of CK0801 in the first half of 2018 to assess its activity, pharmacokinetics and safety in patients with a variety of autoimmune diseases and inflammatory disorders.
About Golden Meditech Holdings Limited (SEHK stock code: 00801)
Golden Meditech (www.goldenmeditech.com) is a leading integrated-healthcare enterprise in China. It is a first-mover in China, having established its dominant positions in several markets including the medical devices market and the hospital management market in the healthcare industry, thanks to its strengths in innovation and market expertise and the ability to capture emerging market opportunities. Going forward, Golden Meditech will continue to pursue a leading position in China’s healthcare industry both through organic growth and strategic expansion.
About Cellenkos, Inc.
Cellenkos, a start-up enterprise co-founded by Golden Meditech, The University of Texas at MD Anderson Cancer Center and an independent strategic investor, is an early stage biotechnology company that focuses on Treg cellular therapies derived from cord blood for the treatment of autoimmune diseases and inflammatory disorders. Cellenkos’ lead product, CK0801, is a first-in-class, cell therapy product that overcomes immune dysfunction by inhibiting key regulators of inflammation.