ImmunityBio, Inc. announced that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China has granted regulatory approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln).

The approval establishes ANKTIVA’s initial presence in Asia and reflects the Company’s strategy to expand global access through reliance-based regulatory pathways. In Macau, ANKTIVA is approved in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± papillary tumors, consistent with its approved use in the United States.

The authorization was granted following a review that considered prior regulatory decisions by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in accordance with applicable local requirements.

“This approval in Macau reflects the strength of the clinical and regulatory foundation supporting ANKTIVA in BCG-unresponsive NMIBC CIS, with or without papillary tumors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The data from QUILT 3.032, published in NEJM Evidence and The Journal of Urology, demonstrate durable responses in this disease setting. As we continue to work with regulatory authorities, our focus remains on enabling global access to an immunotherapy designed to activate NK and T-cell function and address the underlying immune deficit in bladder cancer.”

This approval in Macau represents the first authorization for ANKTIVA in Asia. The Company continues to engage with additional health authorities across the region as part of its international regulatory strategy.

“This authorization marks an important step in establishing ANKTIVA in Asia and advancing our broader international expansion strategy,” said Richard Adcock, President and CEO of ImmunityBio. “We are engaging with additional health authorities across the Asia-Pacific region and, in parallel, beginning to prepare for potential commercial distribution, recognizing there is still meaningful work ahead as we pursue further regulatory authorizations. Our focus is on executing this expansion in a disciplined manner, building on our existing approvals to support long-term global access for patients.”