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Chinese biomedicine company secures first FDA approval for rare cancer treatment [Copy link] 中文

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Post time 2019-11-18 13:43:49 |Display all floors

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

The drug, named Brukinsa, is produced by the Beijing-based biotechnology company BeiGene. It was granted approval from the FDA with “accelerated approval,” according to a statement from the FDA.

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.

“It not only stands for the international recognition of China‘s ability to innovate and develop new treatments, but also is a testimony that China‘s new medicine is able to serve patients around the world,” Wu Xiaobing, CEO of the company told the Global Times.

Around 4 million new cancer patients are diagnosed in China ever year, but 90 percent of the new medicines with patents and intellectual property are imported from abroad.

Imported treatments are usually more expensive because we don‘t have a say in determining the price. Affordability has been a huge issue for China‘s patients,” Wu said.

FDA‘s “accelerated approval” is a mechanism for the FDA to approve drugs for serious medical conditions in which the medical needs have not been met, and are based on a result that is “reasonably likely” to predict benefits for the patients.

According to a statement given to the Global Times from BeiGene, the company also applied for approval to the State Food and Drug Administration (SFDA) in China as a treatment for MCL in August and for chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) in October, and is expected to be granted approval in the Chinese market very soon.(

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Post time 2019-11-19 09:12:52 |Display all floors

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