Novocure’s Optune wins innovative medical device designation from China
The Optune system uses electric fields that are tuned in to specific frequencies to disrupt cancer cell division, according to the company. The technology inhibits tumor growth and causes cancer cells to die. Zai Lab has exclusive licensing rights to NovoCure’s Tumor Treat Fields and Optune in China.
“We are excited that Optune has been granted the Innovative Device Designation as it will allow out team to accelerate dialogue with the NMPA and bring us closer to commercializing Optune in China,” Zai Lab founder & CEO Samantha Du said in a press release. “Our launch in Hong Kong has provided valuable insight into the impact that this device can have on patients with GBM, which is an area of high unmet clinical need in China and globally. We look forward to working closely with the NMPA and Optune advances through the regulatory process in China.”
With the designation, Zai Labs can use an expedited approval procedure for Optune with pre-consultation and input from the NMPA throughout the approval process.
Zai Lab launched Optune in September last year to treat glioblastoma.
“We are committed to bringing Optune to as many patients who may benefit as possible,” NovoCure chairman Bill Doyle said. “Zai Lab has been an excellent partner as we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing Tumor Treating Fields therapy. We are pleased that together with our partners at Zai Lab, we are con step closer to commercializing Optune in China.”