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): August 26, 2018

 

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 8.01Other Events.

 

On August 26, 2018, BeiGene, Ltd. (the “Company”) issued a press release announcing acceptance by the China Drug Administration (CDA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). 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 9.01Financial Statements and Exhibits.

 

(d) Exhibits.

 

     
Exhibit No.   Description
99.1   Press Release titled “BeiGene Announces Acceptance of its First New Drug Application for Zanubrutinib in Relapsed/Refractory Mantle Cell Lymphoma by China Drug Administration” issued on August 26, 2018
     

 

 

 

Exhibit Index

 

     
Exhibit No.   Description
99.1   Press Release titled “BeiGene Announces Acceptance of its First New Drug Application for Zanubrutinib in Relapsed/Refractory Mantle Cell Lymphoma by China Drug Administration” issued on August 26, 2018
     

 

 

 

 

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: August 27, 2018 BEIGENE, LTD.
   
   
  By: /s/ Scott A. Samuels
  Name: Scott A. Samuels
  Title: Senior Vice President, General Counsel