Zai Lab Receives Innovative Medical Device Designation for Tumor Treating Fields in China for Pancreatic Cancer Treatment.

Zai Lab has received an Innovative Medical Device Designation from China's NMPA for Tumor Treating Fields (TTFields) in pancreatic cancer treatment. This designation enables an expedited approval process based on positive Phase 3 PANOVA-3 trial results, which showed a statistically significant improvement in median overall survival. Pancreatic cancer is a significant health challenge in China with an estimated 134,000 new cases annually.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has received an Innovative Medical Device Designation from the China National Medical Products Administration (NMPA) for Tumor Treating Fields (TTFields) in the treatment of pancreatic cancer. This designation, granted based on the positive results of the Phase 3 PANOVA-3 trial, allows for an expedited approval process in China [1].

The PANOVA-3 trial, an international prospective, randomized, open-label, controlled Phase 3 clinical trial, evaluated the use of TTFields therapy in conjunction with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. The trial demonstrated a statistically significant improvement in median overall survival for patients treated with TTFields compared to those who received gemcitabine and nab-paclitaxel alone [1].

The Innovative Medical Device Designation from the NMPA provides Zai Lab with an expedited registration and priority review process, enabling the company to submit its application in China before the approval in the country of origin [1]. This designation is particularly significant given the high incidence of pancreatic cancer in China, with an estimated 134,000 new cases diagnosed annually [2].

Zai Lab is optimistic about the potential of TTFields therapy to address the significant treatment challenges posed by pancreatic cancer. The company plans to submit for regulatory approval in China in the second half of 2025 and anticipates collaborating closely with the NMPA throughout the review process [1].

References:
[1] https://www.morningstar.com/news/business-wire/20250819525540/zai-lab-announces-china-national-medical-products-administration-grants-innovative-medical-device-designation-for-tumor-treating-fields-for-patients-with-pancreatic-cancer
[2] Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590.