Shots:

• The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II trial of zanubrutinib in r/r WM conducted in China and P- I/II trial in patients with B-cell malignancies
• Additionally- safety data from 779 patients in 6 trials of Brukinsa were included in the submission with the anticipated PDUFA date as Oct 18- 2021. Brukinsa is also under regulatory review in the EU- Canada- Australia- China- Taiwan- and South Korea
• Currently- 20+ marketing applications of Brukinsa have been submitted covering 45 countries globally including the US- EU & China

 ­ Ref: BusinessWire | Image: Switzerland Global Enterprise