Zai Lab Announces China National Medical Products Administration Grants Innovative Medical Device Designation for Tumor Treating Fields for Patients with Pancreatic Cancer
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Tumor Treating Fields (TTFields) for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial. The Innovative Medical Device Designation allows Zai Lab to take advantage of an expedited approval procedure for TTFields that offers opportunit
Related Questions
What are the potential revenue and margin impacts from the TTFields pancreatic cancer indication given the market size and reimbursement environment in China?
When is Zai Lab likely to receive final NMPA approval for TTFields in pancreatic cancer and how will that affect the product launch timeline?
How does the Innovative Medical Device Designation and expedited pathway compare to similar designations for competitors' oncology devices in China?