Item 8.01. Other Events.
OnAugust 17, 2021 ,BeiGene, Ltd. ("BeiGene") andEUSA Pharma (UK), Ltd. announced that theChina National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory (R/R) neuroblastoma with or without residual disease. Dinutuximab beta is a targeted immunotherapy approved by theEuropean Medicines Agency . 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press Release titled "BeiGene and EUSA Pharma
Announce China NMPA Approval of
QARZIBA® (Dinutuximab Beta) for Patients with
High-Risk Neuroblastoma",
issued byBeiGene, Ltd. onAugust 17, 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 and EUSA Pharma
Announce China NMPA Approval of
QARZIBA ® (Dinutuximab Beta) for Patients
with High-Risk Neuroblastoma",
issued byBeiGene, Ltd. onAugust 17, 2021 . 104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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