Item 8.01. Other Events.
OnJanuary 20, 2022 ,BeiGene, Ltd. ("the Company") issued a press release announcing that theCenter for Drug Evaluation (CDE) of theChina National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) forBeiGene's BTK inhibitor BRUKINSA® (zanubrutinib) as a treatment for adult patients with Waldenström's macroglobulinemia (WM). A copy of this press release is attached hereto as Exhibit 99.1, and is incorporated herein by reference. OnJanuary 24, 2022 , the Company issued a press release announcing positive findings from the global Phase 3 RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. At the interim analysis, tislelizumab in combination with chemotherapy met the primary endpoint of overall survival (OS) in patients with PD-L1 expression, with additional follow-up needed to confirm OS benefits in the intention-to-treat (ITT) population. The safety profile of tislelizumab was consistent with that observed in previous trials, with no new safety signals identified with the addition of chemotherapy. A copy of this press release is attached hereto as Exhibit 99.2, 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
Acceptance of a Supplemental New Drug
Application inChina for BRUKINSA (zanubrutinib) in Waldenström's Macroglobulinemia," issued byBeiGene, Ltd. onJanuary 20, 2022 . 99.2 Press Release titled "BeiGene Announces Positive
Findings from Phase 3 Trial of
Tislelizumab in Combination with Chemotherapy in
First-Line Gastric or
Gastroesophageal Junction Cancer," issued by
104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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