Item 8.01. Other Events.
OnJune 10, 2022 ,BeiGene, Ltd. ("BeiGene") announced that it was presenting data from its hematology portfolio at theEuropean Hematology Association (EHA) 2022Hybrid Congress being heldJune 9-12, 2022 , inVienna, Austria . 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 10, 2022 ,BeiGene announced that theChina National Medical Products Administration (NMPA) approvedBeiGene's anti-PD-1 antibody, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). 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. OnJune 13, 2022 ,BeiGene announced that theU.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date by three months toJanuary 20, 2023 for the supplementary new drug application (sNDA) for BRUKINSA as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The full text of this press release is filed as Exhibit 99.3 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 Highlights Growing Portfolio and Pipeline Targeting Hematologic Malignancies at European
Congress " issued byBeiGene, Ltd. onJune 10 ,
2022
99.2 Press release titled "China NMPA Approves
Tislelizumab for Recurrent or
Metastatic Nasopharyngeal Cancer" issued by
99.3 Press release titled "BeiGene Announces PDUFA
Goal Date Extension for
sNDA for BRUKINSA for the Treatment of CLL/SLL"
issued by
June 13, 2022 104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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