Document


 
 
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): January 14, 2019





 
BEIGENE, LTD.
(Exact name of registrant as specified in its charter)





 
Cayman Islands
 
001-37686
 
98-1209416
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(I.R.S. Employer Identification No.)
 
c/o Mourant Ozannes Corporate Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
(Address of principal executive offices) (Zip Code)
 
+1 (345) 949 4123
(Registrant’s telephone number, including area code)
 
Not Applicable
(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))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
 
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 January 14, 2019, BeiGene, Ltd. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
Item 9.01
 
Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
Description
99.1
 
 
 
 
 
 
 
 
 
 






 
Exhibit Index
 
 
 
 
Exhibit No.
 
Description
99.1
 
 
 






 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
Date: January 14, 2019
BEIGENE, LTD.
 
 
 
 
 
By:
/s/ Scott A. Samuels
 
Name:
Scott A. Samuels
 
Title:
Senior Vice President, General Counsel
 
 
 




Exhibit 99.1