UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): April 23, 2018
 
CELLULAR BIOMEDICINE GROUP, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-36498
 
86-1032927
(State or other Jurisdiction of Incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
19925 Stevens Creek Blvd., Suite 100
Cupertino, California
 
95014
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (408) 973-7884
 
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
 


 
 
Item 8.01       
Other Events.
 
On April 21, 2018, the China Food and Drug Administration (CFDA) Center for Drug Evaluation (CDE) posted on its website acceptance of the Investigative New Drug (IND) application for chimeric antigen receptor T cells (CAR-T) cancer therapies in treating patients with adult acute lymphoblastic leukemia (ALL) submitted by Cellular Biomedicine Group (Shanghai) Ltd. and Shanghai Cellular Biopharmaceutical Group Ltd., two of our wholly-owned subsidiaries of Cellular Biomedicine Group, Inc. (collectively, the Company). There can be no assurance that the application will ultimately be approved.
 
In December 2017, the Chinese government issued clinical trial guidelines concerning development and testing of cell therapy products, including immune cell therapies such as CAR-T cell therapeutics. The Company currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 (CAR-T Against DLBCL) for NHL and Diffuse Large B-cell Lymphoma (DLBCL), and CALL-1 (CAR-T against Acute Lymphoblastic Leukemia) CD19 CAR-T therapy utilizing its optimized proprietary C-CAR011 construct for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell ALL.

 
 
 
 
 
 

 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
Cellular Biomedicine Group, Inc.
 
 
 
 
 
Date: April 23, 2018
By:
/s/ Bizuo (Tony) Liu
 
 
 
Bizuo (Tony) Liu
 
 
 
Chief Executive Officer