Item 8.01. Other Events.
OnSeptember 17, 2021 ,BeiGene, Ltd. ("BeiGene") announced that the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) has adopted a positive opinion, recommending approval of BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy. 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. OnSeptember 20, 2021 ,BeiGene announced its inclusion in several FTSE Russell indices, including: the FTSE Global Equity Index Large Cap; the FTSE All-World (LM); the FTSE All-Cap (LMS); and the FTSE Total-Cap (LMSµ). In addition,BeiGene has also been included in the FTSE Developed ESG Low Carbon Select Index, and the FTSE Asia ex Japan ESG Low Carbon Select Index, reflecting the company's commitment to sustainability. The company's inclusion on theFTSE indices became effective onFriday, September 17, 2021 , after U.S. market close. 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 BRUKINSA®
(Zanubrutinib) for the Treatment of Adults with
Waldenström's Macroglobulinemia",
issued byBeiGene, Ltd. onSeptember 17, 2021 . 99.2 Press Release titled "BeiGene Announces Inclusion
in FTSE Russell Indices", issued
byBeiGene, Ltd. onSeptember 20, 2021 . 104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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Exhibit Index Exhibit No. Description 99.1 Press Release titled " BeiGene Receives
Positive CHMP Opinion for
BRUKINSA ® (Zanubrutinib) for the
Treatment of Adults with Waldenström's
Macroglobulinemia ", issued byBeiGene, Ltd.
on
99.2 Press Release titled " BeiGene Announces
Inclusion in FTSE Russell
Indices ", issued byBeiGene, Ltd. on
104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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