Item 8.01. Other Events.
OnSeptember 13, 2021 ,BeiGene, Ltd. ("BeiGene") announced that theU.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date isJuly 12, 2022 . 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 15, 2021 ,BeiGene announced that BRUKINSA® (zanubrutinib) has received accelerated approval from theU.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. 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 AnnouncesU.S. FDA
Acceptance of Biologics
License Application for Tislelizumab in
Esophageal Squamous Cell Carcinoma",
issued byBeiGene, Ltd. onSeptember 13, 2021 . 99.2 Press Release titled "U.S. FDA Grants BRUKINSA®
(Zanubrutinib) Accelerated
Approval in Relapsed or Refractory Marginal Zone Lymphoma", issued byBeiGene, Ltd. onSeptember 15, 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 P ress Release titled "BeiGene Announces
License Application for Tislelizumab in
Esophageal Squamous Cell Carcinoma",
issued by BeiGene, Ltd. on September 13, 2021. Press Release titled "U.S. FDA Grants BRUKINSA ® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory
Marginal Zone Lymphoma ",
issued byBeiGene, Ltd. onSeptember 15, 2021 . 104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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