SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): May 19, 2021
(Exact Name of Registrant as Specified in Charter)
(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
(Address of Principal Executive Offices) (Zip Code)
+1 (345) 949-4123
(Registrant's telephone number, including area code)
(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 class||Trading Symbol(s)||Name of each exchange on which registered|
|American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share||BGNE||The NASDAQ Global Select Market|
|Ordinary Shares, par value $0.0001 per share*||06160||The 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 registered or 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 May 19, 2021, BeiGene, Ltd. ("BeiGene") announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application for BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy and granted priority review. The Prescription Drug User Fee Act (PDUFA) target action date is September 19, 2021. 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 May 21, 2021, BeiGene announced that the Phase 3 RATIONALE 309 trial of its anti-PD-1 antibody tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer met its primary endpoint of progression-free survival (PFS) at the interim analysis, as recommended by an independent data monitoring committee. In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat population when compared to chemotherapy alone, as assessed by an independent review committee. The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy. 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.
Press Release titled "BeiGene Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for BRUKINSA® (Zanubrutinib) in Marginal Zone Lymphoma", issued by BeiGene, Ltd. on May 19, 2021.
|99.2||Press Release titled "BeiGene Announces Positive Topline Results from Phase 3 Trial of Tislelizumab in Combination with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer", issued by BeiGene, Ltd. on May 21, 2021.|
|104||The cover page from this Current Report on Form 8-K, formatted in Inline XBRL|
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: May 21, 2021||By: ||/s/ Scott A. Samuels |
| ||Name:||Scott A. Samuels|
| ||Title:||Senior Vice President, General Counsel|