BeiGene Soars After Clinching First US Approval for a Chinese Cancer Drug
Dou Shicong
DATE:  Nov 16 2019
/ SOURCE:  yicai
BeiGene Soars After Clinching First US Approval for a Chinese Cancer Drug BeiGene Soars After Clinching First US Approval for a Chinese Cancer Drug

(Yicai Global) Nov. 15 -- BeiGene's shares surged today after the biopharmaceutical firm's immunotherapy treatment Brukinsa became the first Chinese cancer drug approved by US regulators.

BeiGene's stock [HKG:6160] closed 6.6 percent higher at HKD125.40 (USD16) in Hong Kong, after earlier gaining by 10 percent, while its US-listed shares [NASDAQ:BGNE] jumped more than 4 percent in pre-market trading.

Brukinsa can be used in the treatment of adult patents with mantle cell lymphoma who have received at least one prior therapy, the US Food and Drug Administration said on its website yesterday. "Clinical trials showed that 84% of patients saw tumor shrinkage with this therapy," it said.

The FDA's accelerated approval of Brukinsa marks a breakthrough for China's innovative medicine sector. It is BeiGene's first self-developed drug and is proof that the USD1.66 billion the Beijing-based firm has spent on research and development since 2016 is paying off. The drug should also help push the company back into the black. Its losses doubled to USD307 million in the third quarter from a year earlier.

Also known as zanubrutinib, Brukinsa capsules will be available to US patients in the coming weeks, BeiGene said in a statement yesterday. China's National Medical Products Administration is also prioritizing its review of the drug's sales application, the firm added.

Mantle cell lymphoma is a rare, aggressive form of blood cancer that mostly affects men aged over 60. About 6 percent of some 74,200 new cases of non-Hodgkin's lymphoma, a group of blood cancers, that were diagnosed this year were MCL. MCL patients normally have a poor prognosis and are only given three to four years to live, BeiGene said.

Follow Yicai Global on
Keywords:   BeiGene,Lymphoma,FDA