China has granted market access to a self-developed cancer drug, according to the National Medical Products Administration on Saturday.
The drug, known as Brukinsa (zanubrutinib) in capsule form, was developed by the biotechnology company BeiGene. It is for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and also for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).The drug was approved through a priority review procedure and its marketing authorization holder should continue with the confirmatory clinical trials, according to the administration.
The approval of the drug will provide an important treatment option for Chinese patients with lymphoma.
Wu Xiaobin, president of BeiGene said the development of the drug has taken more than eight years and around 25 clinical trials have been carried out in more than 20 countries, involving more than 500 international clinical experts. More than 1,700 patients have joined the clinical trials globally.
The approval of the drug also underlines China’s progress in developing innovative drugs, Wu said.
In November last year, the drug received approval from the U.S. Food and Drug Administration as a treatment for MCL in adult patients who have received at least one prior therapy.
Wang Zhiwei, vice president of BeiGene said the company’s production line in the city of Suzhou, east China’s Jiangsu Province has an annual output of 100 million capsules, which can ensure the demand of the domestic market as well as the international market.Lymphoma is a type of blood cancer which has seen increasing incidence both in China and the world.