Macau Grants First Asian Approval To ImmunityBio’s ANKTIVA For Bladder Cancer, Expands Global Reach As ANKTIVA Wins Regulatory Clearance

ImmunityBio, Inc. announced that the Pharmaceutical Administration Bureau of Macau (ISAF) has approved ANKTIVA® (nogapendekin alfa inbakicept-pmln). The decision marks the therapy’s first regulatory authorization in Asia and supports the company’s strategy to broaden global patient access through reliance-based approval pathways.

“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.”

In Macau, ANKTIVA is authorized for use in combination with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer, including carcinoma in situ with or without papillary tumors. The indication aligns with the medicine’s approved use in the United States.

Regulators granted the authorization after reviewing prior decisions by major international agencies, including the U.S. Food and Drug Administration and the European Medicines Agency, in accordance with Macau’s local regulatory framework.

“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.”

The Macau clearance represents ImmunityBio’s first market entry for ANKTIVA in Asia. The company is continuing discussions with additional regional health authorities as part of its broader international expansion plan.