0001651308false00016513082022-09-192022-09-19

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): September 19, 2022

BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)
Cayman Islands001-37686
98-1209416
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
c/o Mourant Governance 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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per shareBGNEThe NASDAQ Global Select Market
Ordinary Shares, par value $0.0001 per share*06160The Stock Exchange of Hong Kong Limited
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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. o


Item 8.01. Other Events.

On September 19, 2022, BeiGene, Ltd. ("BeiGene") announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based 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.

On September 20, 2022, BeiGene announced that England's health technology assessment institute, the National Institute for Health and Care Excellence, has issued a final appraisal document recommending BRUKINSA® (zanubrutinib) for the treatment of Waldenström's Macroglobulinemia in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable. The full text of this press release is filed as Exhibit 99.2 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
Press release titled "BeiGene Receives Positive CHMP Opinion for BRUNKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma" issued by BeiGene on September 19, 2022
99.2
Press release titled "NICE Recommends BeiGene's BRUKINSA® (zanubrutinib) for Patients with Waldenström's Macroglobulinemia who have at least One Treatment" issued by BeiGene, Ltd. on September 20, 2022
104The cover page from this Current Report on Form 8-K, formatted in Inline XBRL




Exhibit Index 



SIGNATURE
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.
 BEIGENE, LTD.
   
   
Date: September 22, 2022By: /s/ Chan Lee
 Name:Chan Lee
 Title:
Senior Vice President, General Counsel



Beigene (PK) (USOTC:BEIGF)
Historical Stock Chart
From Jun 2024 to Jul 2024 Click Here for more Beigene (PK) Charts.
Beigene (PK) (USOTC:BEIGF)
Historical Stock Chart
From Jul 2023 to Jul 2024 Click Here for more Beigene (PK) Charts.