BeiGene Shares Rise 5% After EC Marketing Authorization for Brukinsa

By Chris Wack

BeiGene Ltd. shares were up 5% to $177.49 Wednesday after the biotechnology company said that the European Commission granted marketing authorization to Brukinsa zanubrutinib for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

The company said the approval is applicable to all 27 member states of the European Union, plus Iceland and Norway.

The EC granted an additional year of marketing protection because the data submitted for the therapeutic indication demonstrated a significant clinical benefit for Brukinsa in comparison with existing therapies, BeiGene said.

The EC approval follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency. In the trial, Brukinsa achieved a high overall response rate of 68% with 26% of patients achieving complete remission, as assessed by an Independent Review Committee.

Brukinsa was generally well-tolerated and safety was consistent with its established profile.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

November 02, 2022 10:20 ET (14:20 GMT)

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