(Yicai Global) May 14 -- China has approved Optune, a wearable electric field treatment device developed by Chinese biopharmaceutical firm Zai Lab and Novovure, an American tumor therapy innovation company. It will be used to treat glioblastoma, an extremely high-risk tumor of the nervous system.
China’s National Medical Products Administration issued a statement today giving the nod for the product to be sold. This is the first time that China has allowed a medical device that uses Tumor Treating Fields therapy which suppresses mitosis of tumor cells by forming a low-intensity AC electric field inside the tumor to eventually delay or even reverse tumor growth.
The US approved the therapy invented by Novocure for the treatment of gliomas as early as 2011 and it has so far treated more than 15,000 patients worldwide. Shanghai-based Zai Lab was exclusively licensed by Novocure in September 2018 and is responsible for development and marketing in China.
Glioma has a high degree of malignancy and is one of the most difficult tumors to treat due to its rapid growth, easy recurrence, and high disability after surgery. The glioblastoma is the most malignant among glioma. The five-year survival rate of patients is less than 5 percent, or even less than a third that of lung cancer.
More than 45,000 patients are diagnosed with glioblastoma every year in China but current treatments are very limited, Jiang Tao, director of the Beijing Academy of Neurosurgery, told Yicai Global.
Optune is approved by the US Food and Drug Administration, through humanitarian device exemption, for the treatment of pleural mesothelioma. Its market application for this disease will be submitted in China soon. The two companies are also collaborating on treatment for other indications, including brain metastases, lung cancer, pancreatic cancer, and ovarian cancer.
Editors: Dou Shicong, Peter Thomas