Dive Brief:

• Novocure and Zai Lab have received a Chinese innovative medical device designation for cancer treatment Optune, similar to breakthrough status available in the U.S. 

• The device, which is cleared for use in the U.S., delivers low-intensity, wave-like electric fields to slow or stop the division of brain cancer cells.​

• Zai Lab, operating under a license from Novocure, will now try to use the additional dialogue with regulators and truncated review times offered by the designation to bring the device to market in China.

Dive Insight:

Novocure granted Zai Lab an exclusive license to sell Optune in greater China in September. By the end of the year, Zai Lab, a Chinese biopharma company, had brought the device to market in Hong Kong.

Zai Lab has furthered its plans to get the device cleared for use in mainland China. The boost to Zai Lab’s prospects stems from the receipt of an innovative medical device designation from China’s National Medical Products Administration.

Given the relative lack of communication between NMPA and device developers, the additional opportunities to talk to the agency about development and filing are among the key benefits of the designation. 

Recent history suggests Zai Lab can also expect an expedited review if it reaches the filing stage. The 21 devices with innovative designation approved by NMPA last year completed regulatory review 83 days faster than other newly authorized technologies. 

A growing number of devices are benefiting from such perks. In 2015, nine devices with the designation came to market in China. The figure rose to 12 in 2017 and jumped to 21 last year, reflecting how the designation is now an established part of device regulation in China. 

NMPA’s predecessor implemented a version of the designation in 2014. A review of the pathway late last year changed some of the criteria and processes, for example, by adding 20 days to the application review timeline, but the core benefits of the designation remained unchanged. 

Companies that take advantage of those opportunities will get the chance to compete for a growing market. The U.S. International Trade Administration estimates the Chinese device market will be worth $96.3 billion this year, up from $53.6 billion in 2016. 

Despite the growth, the data suggest there is room for the market to get even bigger. The worldwide medical device market is around 42% as large as the pharmaceutical market. However, in China, the device market is around 14% of the size of the pharmaceutical sector.

Zai Lab will benefit from some tailwinds if it wins approval and tries to compete with medicines for the brain cancer market. Treatment guidelines for glioma, a form of brain cancer, published in China last year, list tumor treating fields as a recommended therapy in the indication.