Zai, Novocure’s tumor treatment device granted innovative status

Shanghai-based biotech Zai Lab Ltd (NASDAQ: ZLAB) announced that its Optune device, based on Tumor Treating Fields (TTF) technology in-licensed from Israel-based partner Novocure (NASDAQ: NVCR), has been designated an “Innovative Medical Device” by the National Medical Products Administration (NMPA). Currently awaiting market approval from the agency, the designation is expected to accelerate the path to regulatory decision and allow a greater degree of communication between Zai and NMPA regulators.

The Optune product is a portable, non-invasive medical device for treatment of tumors based on the application of TTF, electric fields tuned to specific frequencies in order to disrupt cell division, inhibit tumor growth, and cause cancer cell death. The device is set for use in glioblastoma (GBM) patients alongside chemotherapy, and was approved in Hong Kong and launched to market in December 2018 for that indication. Optune was in-licensed from Novocure in a September 2018 deal, Zai Lab making a USD 15 million upfront payment for development rights to the technology in Greater China.


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