File photo: IC

The US Food and Drug Administration (FDA) granted the first approval for a Chinese cancer therapy on Thursday, a milestone for China's biotech industry. 

The drug, named Brukinsa, is produced by Beijing-based biotechnology company BeiGene. It was given "accelerated approval" by the FDA, the agency said in a statement.

Brukinsa is an inhibitor intended for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy for the disease. MCL is an aggressive blood cancer that can spread to the lymph nodes, bone marrow and other organs by the time it is diagnosed. 

The decision "not only stands for the international recognition of China's ability to innovate and develop new treatments, but it also is testimony that China's new medicine is able to serve patients around the world," President of BeiGene Xiaobin Wu told the Global Times.  

Around 4 million new cancer patients are diagnosed in China every year, but 90 percent of the latest cancer treatments with patents and intellectual property are imported. 

"Imported treatments are usually more expensive," Wu said. "We don't have a say in determining the price. Affordability has been a huge issue for China's patients."

"Accelerated approval" is a mechanism for the FDA to approve drugs for serious medical conditions for which the medical need has not been met, based on a result that is "reasonably likely" to predict benefits to the patients. 

The FDA's approval was based on collected data from clinical trials, which showed that 84 percent of patients witnessed a shrinkage in tumors with the Brukinsa treatment. 

According to a statement from BeiGene, the company applied for approval to the State Food and Drug Administration in China as a treatment for MCL in August and for chronic lymphocytic leukemia and small lymphocytic lymphoma in October, and is expected to be granted approval in the Chinese market very soon.