US: FDA Approves First Chinese Cancer Drug for U.S. Patient Use - - PressFrom - US
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US FDA Approves First Chinese Cancer Drug for U.S. Patient Use

07:30  15 november  2019
07:30  15 november  2019 Source:   bloomberg.com

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The U . S . Food and Drug Administration has granted approval to a blood cancer drug from Beijing-based BeiGene Ltd BeiGene has emerged as one of the most promising Chinese biotech companies and the new drug , also known as zanubrutinib, is the first in a raft of cancer drugs it is readying for

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs , biological products, and medical devices; and by ensuring the safety of our nation' s food supply, cosmetics, and products that products that emit radiation.

(Bloomberg) -- The U.S. Food and Drug Administration has granted approval to a blood cancer drug from Beijing-based BeiGene Ltd., paving the way for American patients to access a Chinese cancer therapy for the first time.

Inside BeiGene Ltd.'s Research and Development Center© Bloomberg Inside BeiGene Ltd.'s Research and Development Center

The accelerated approval -- ahead of even China’s own national drug regulator -- marks a breakthrough for the growing legion of Chinese biotech companies determined to take on the world’s biggest pharmaceutical companies in medical innovation and scientific research.

A researcher prepares a sample inside a BeiGene’s research and development center in Beijing.

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The Food and Drug Administration approved a first -of-its kind cancer therapy aimed at bolstering a patient ’ s own immune cells The procedure can only be undertaken at a limited number of facilities in the U . S . It is highly tailored to individual patients and can take the better part of a month to complete.

Original New Drug Approvals (NDAs and BLAs) by Month All applications approved for the first time during the selected month. Includes New Molecular Entities (NMEs) and new biologics. Not all biologics are in Drugs @ FDA . Does not include tentative approvals .

BeiGene’s Brukinsa capsules was approved for patients with mantle cell lymphoma that have already received other therapies earlier, and will be a competitor to similar blood cancer therapies from AbbVie Inc. and AstraZeneca Plc. BeiGene’s Hong Kong-listed shares rose by as much as 12% to a record high on Friday after the announcement.

China Is Striving for the World’s Best, Cheapest Healthcare

Investment into Chinese biotech startups is surging as the opening up of the Asian giant’s $132 billion pharmaceutical market creates an unprecedented profit-making opportunity for health-care companies. Last week, AstraZeneca announced a $1 billion fund with a Chinese investment bank to support local drug research, while a Shanghai-based company received Chinese regulatory approval for the first new Alzheimer’s drug in 17 years.

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The U . S . Food and Drug Administration recently granted accelerated approval to the first immunotherapy treatment for breast cancer . FDA Approves First Immunotherapy Drug for Triple-Negative Breast Cancer . Written by Kristen Fischer on March 15, 2019.

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BeiGene has emerged as one of the most promising Chinese biotech companies and the new drug, also known as zanubrutinib, is the first in a raft of cancer drugs it is readying for regulatory approval. In a vote of confidence in its pipeline, American generics giant Amgen Inc. bought a 20.5% stake in BeiGene earlier this month for $2.7 billion to jointly develop cancer therapies.

BeiGene said it expects to see another one of its cancer drugs, Tislelizumab, approved by the Chinese regulator by the end of this year. It has not yet disclosed pricing details for Brukinsa.

To contact Bloomberg News staff for this story: Dong Lyu in Beijing at dlyu3@bloomberg.net

To contact the editor responsible for this story: Rachel Chang at wchang98@bloomberg.net

For more articles like this, please visit us at bloomberg.com

©2019 Bloomberg L.P.

Man Found Burned After Suspected Drug Lab Explodes In Million-Dollar Arcadia Home .
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