FDA Approves First Chinese Cancer Drug for U.S. Patient Use

(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.

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.

“This means we are not only bringing new drugs into China, we are also bringing new drugs from China to the whole world,“ said BeiGene President Wu Xiaobin at a press conference on Friday in Beijing. “Chinese biotech is on the rise. The industry is not yet on top of the world but we are quickly closing the gap.”

FDA Approves First Chinese Cancer Drug for U.S. Patient Use

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 6.6% to a record high on Friday.

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.

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.

©2019 Bloomberg L.P.

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