US drug regulators have issued their first ever approval for a Chinese-developed innovative cancer treatment, marking a breakthrough for the country’s biotech sector.
The US Food and Drug Administration approved zanubrutinib, a treatment for mantle cell lymphoma, a rare kind of blood cancer, produced by BeiGene in Beijing under the name Brukinsa. The drug can be used by patients who have received one prior therapy for the disease.
Chinese companies aiming to develop new drugs, often founded by former executives at multinational companies, have proliferated in recent years and raised billions from venture capital investors and through public listings.
The number of innovative molecules in development at Chinese biotech companies
Since 2015, Beijing has accelerated approvals of drugs developed by local biotech companies. But approvals by the FDA, which oversees the world’s largest drug market, are seen as being of greater symbolic and commercial importance.
“It’s definitely a milestone for the Chinese biotech industry,” said Zhao Bing, an analyst at Chinese brokerage Huajing Securities. “More Chinese biotechs are following BeiGene’s model, to innovate not only for China but for the global market.”
There are about 800 innovative molecules in development at Chinese biotechs, a number that has more than tripled since 2012. Of those, 70-80 are in late-stage trials, according to consultancy McKinsey.
“There will be more innovative [Chinese] drugs approved by the FDA in the near future,” said Wang Gang, a scientist at consultancy Clarivate Analytics.
About 3,000 people are diagnosed with mantle cell lymphoma in the US each year. The FDA, which has given the green light to the use of dozens of Chinese generic drugs, gave approval to BeiGene’s Brukinsa capsules under an accelerated scheme for new drugs.
The FDA relied largely on trial data generated outside the US for the approval. The company tested the treatment on 118 patients, 10-15 per cent of whom were from the US, the company said.
BeiGene’s treatment will be manufactured under contract in the US for use by local patients. It will compete with drugs from established US companies such as AbbVie and Celgene, and the UK-Swedish group AstraZeneca.
BeiGene has close links with US biotech companies. Celgene took an $150m equity stake in the Chinese company in 2017, while Amgen last month acquired a 20.5 per cent stake in BeiGene for about $2.7bn
The company, which is dual-listed on Nasdaq and the Hong Kong stock exchange, was co-founded by John Oyler, who is from the US. The company’s president, Xiaobin Wu, is a former Pfizer executive.
Shares in BeiGene fell sharply in September when a US short seller accused BeiGene of “faking” 60 per cent of its sales. The Chinese company denied the accusations.
The company’s Hong Kong-listed shares rose as much as 6.8 per cent on Friday following news of the US approval.
The post US grants first approval for China cancer treatment appeared first on Financial Times.