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BGNE BeiGene Ltd

162.54
-0.73 (-0.45%)
27 Jul 2024 - Closed
Delayed by 15 minutes
Name Symbol Market Type
BeiGene Ltd NASDAQ:BGNE NASDAQ Depository Receipt
  Price Change % Change Price Bid Price Offer Price High Price Low Price Open Price Traded Last Trade
  -0.73 -0.45% 162.54 158.70 166.50 165.50 161.70 163.82 101,487 01:00:00

BeiGene Gets Positive CHMP Opinion for Tislelizumab to Treat Serious Esophageal Cancer

21/07/2023 1:33pm

Dow Jones News


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By Chris Wack

 

BeiGene said Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval for tislelizumab to treat adults with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma.

The biotechnology company said the marketing authorization application for esophageal squamous cell carcinoma is based on results from its Phase 3 study of tislelizumab's efficacy and safety.

The study enrolled 513 patients in 11 countries in Asia, Europe and North America. The study met its primary endpoint with a statistically significant and clinically meaningful survival benefit for tislelizumab compared with chemotherapy.

Tislelizumab isn't currently authorized for use in Europe.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

July 21, 2023 08:18 ET (12:18 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.

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