Item 8.01. Other Events.
OnJune 26, 2021 ,BeiGene, Ltd. (the "Company" or "BeiGene") announced that BRUKINSA® (zanubrutinib) has been approved byHealth Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This is the second approval for BRUKINSA inCanada , following its initial approval inMarch 2021 for adult patients with Waldenström's macroglobulinemia (WM). 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. OnJune 29, 2021 , the Company announced positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing BRUKINSA® (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose tumor did not exhibit the deletion of chromosome 17p13.1 (del[17p]). 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 Announces Approval inCanada of BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Mantle Cell Lymphoma", issued byBeiGene, Ltd. onJune 26, 2021 . 99.2 Press Release titled "BeiGene Announces Positive
Topline Results from Phase 3
SEQUOIA Trial Comparing BRUKINSA® (Zanubrutinib)
to Bendamustine Plus
Rituximab in Patients with Treatment-Naïve
Chronic Lymphocytic Leukemia",
issued byBeiGene, Ltd. onJune 29, 2021 . 104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
--------------------------------------------------------------------------------
Exhibit Index Exhibit No. Description 99.1 Press Release titled " BeiGene Announces Approval in Canada of BRUKINSA ® (Zanubrutinib) for the
Treatment of Patients with Mantle
Cell Lymphoma ", issued byBeiGene, Ltd. on
99.2 Press Release titled " BeiGene Announces
Positive Topline Results from
Phase 3 SEQUOIA Trial Comparing BRUKINSA
® (Zanubrutinib) to
Bendamustine Plus Rituximab in Patients with
Treatment-Naïve Chronic
Lymphocytic Leukemia ", issued by BeiGene,
Ltd. on
104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
--------------------------------------------------------------------------------
© Edgar Online, source