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Share Name Share Symbol Market Type Share ISIN Share Description
Glaxosmithkline Plc LSE:GSK London Ordinary Share GB0009252882 ORD 25P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -15.00 -0.91% 1,636.20 1,636.00 1,636.40 1,651.00 1,629.60 1,642.20 1,640,437 11:15:28
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 33,754.0 6,221.0 93.9 17.4 82,089

Zai Lab Says China Supplemental New Drug Application for Zejula Accepted

16/03/2020 12:21pm

Dow Jones News


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By Michael Dabaie

 

Zai Lab Ltd. said the China National Medical Products Administration accepted its supplemental new drug application for Zejula as a maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The company said the Prima study, conducted by partner GlaxoSmithKline PLC, demonstrated Zejula treatment resulted in a 38% reduction in the risk of disease progression or death in the overall study population when compared to placebo. Zejula demonstrated benefits in all patient subgroups, the company said.

For patients whose cancer is associated with homologous recombination deficiency positive status, Zejula treatment resulted in a 57% reduction in the risk of disease progression or death, Zai Lab said.

GSK submitted a sNDA to the U.S. Food and Drug Administration for the use of Zejula in ovarian cancer as first-line maintenance treatment and the application was accepted in February.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

March 16, 2020 08:06 ET (12:06 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.

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