Cellular Biomedicine Group (CBMG) Announces Completion of Wuxi GMP Facility Expansion
SHANGHAI, China and CUPERTINO, Calif., March 30, 2017 /GlobeNewswire/ — Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a leading clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, today announced the completion of its newly expanded 30,000 square foot facility in Huishan High Tech Park in Wuxi, China. 20,000 square feet of the Wuxi GMP facility will be dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents. By the end of 2017, the Company anticipates that the combination of this Wuxi site, the new Zhangjiang Shanghai and the Beijing GMP facilities will be capable of supporting simultaneous clinical trials for five different CAR-T and stem cell products, or capacity to treat up to 10,000 cancer and 10,000 Knee Osteoarthritis (KOA) patients per year.
“As we have previously stated, this marks a key milestone in our corporate development in the first quarter of 2017 as we continue to invest in and expand our capabilities in advanced CAR-T and stem cell manufacturing. We have long recognized the logistical challenges of delivering consistent, quality and clinical grade processes to deliver cell therapies to market and we have differentiated our capabilities to meet this challenge. We will now be able to centralize, standardize and automate our manufacturing capabilities fully in-house while enhancing our capacity to meet the production demands of multiple products in development as part of our overall Chemistry, Manufacturing, and Controls (“CMC”) process,” said Tony (Bizuo) Liu, Chief Executive Officer of Cellular Biomedicine Group.“The Wuxi facility is equipped with six independent production lines and will be capable of producing and banking low endotoxin high transfection rate plasmids, and high titer automated and purified virus with stringent quality control,” commented Helen Zhang, SVP of Technology & Manufacturing for CBMG.
CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was also recently awarded $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM for Knee Osteoarthritis in the United States.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was also recently awarded $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM for Knee Osteoarthritis in the United States. To learn more about CBMG, please visit www.cellbiomedgroup.com.
This press release contains forward-looking statements—including descriptions of plans, strategies, trends, specific activities, investments and other non-historical facts—as defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently uncertain, and actual results could differ materially from those anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy (including the devaluation of the RMB by China in August 2015), and other risks detailed in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” “continue” or similar terms or their negations. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
Director of Corporate Communications, CBMG
Managing Director Investor Relations, Citigate Dewe Rogerson
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