BeiGene, a Beijing-based commercial-stage biotechnology company, announced on Wednesday the approval of a self-developed lymphoma drug from the National Medical Products Administration, marking China’s first self-developed BTK inhibitor — a cancer treatment — coming into the market.
The drug, known as Brukinsa, is also the first entry of an innovative cancer drug from a Chinese company into the United States. The drug received accelerated approval from the US Food and Drug Administration as a treatment for mantle cell lymphoma in adult patients who have received at least one prior therapy in November 2019.
“The approval of the drug will provide an important treatment option for Chinese patients with lymphoma. In addition to its significant anti-tumor activity, the drug demonstrated a favorable safety and tolerability profile,” said Li Jianyong, professor and director of the department of hematology and director of the Pukou chronic lymphocytic leukemia center at the First Affiliated Hospital of Nanjing Medical University.
The drug is also the first self-developed cancer drug recommended by both the lymphoma treatment plan issued by the Chinese Society of Clinical Oncology and the United States National Comprehensive Cancer Network guidelines.
Zhu Jun, professor and director of the department of internal medicine and lymphoma at Peking University Cancer Hospital said: “The drug’s approval in both China and the US is encouraging for Chinese biopharmaceutical firms. The fact that China’s self-developed cancer drug conducted clinical trials locally, the clinical data conformed to international standards, and was granted market access to the US and now China, proved the advanced and scientific nature of research and development, and international versatility of Chinese drugs.”
It set a good example for Chinese innovative drugs going global. Meanwhile, Chinese cancer patients won’t have to wait for a long time for internationally approved drugs to enter China, and they won’t have to pay a high price for the imported drugs. It is a blessing for patients around the world, he said.
BeiGene President Wu Xiaobin said the green light also underlines China’s progress in upgrading its pharmaceutical sector from its traditional strategy of making generic drugs to innovation-driven drug development.
“Chinese biotech firms are on the rise and are set to benefit patients in developed and developing countries alike,” he added.
“The approvals of the drug are a tribute to the collective expertise and hard work of the BeiGene team. In the future, we will continue to focus on execution in advancing our broad portfolio,” said John V. Oyler, co-founder CEO and chairman of BeiGene.
Zhu said in terms of drug innovation, China has made great progress from merely a follower, to gradually catching up. However, a lot of problems still remain. Chinese pharmaceutical companies should keep the momentum in innovation, constantly learn from the Western world, and standardize its treatment.
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