ImmunityBio Receives Macau Approval for ANKTIVA® in BCG-Unresponsive Bladder Cancer
CULVER CITY, Calif. – March 21, 2026 – ImmunityBio, Inc. (NASDAQ: IBRX) announced today 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 is for use 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.
First Asian Authorization and Regulatory Pathway
This marks ANKTIVA’s first regulatory authorization in Asia, representing a key step in ImmunityBio’s global expansion strategy across 34 countries and territories. The approval was granted through a reliance-based review process, leveraging prior decisions made by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) . This pathway allows for expedited access to innovative therapies by considering assessments from established regulatory bodies.
Addressing an Unmet Demand in Bladder Cancer Treatment
BCG-unresponsive NMIBC with CIS represents a significant clinical challenge, as treatment options are limited when standard BCG therapy fails. Radical cystectomy, the surgical removal of the bladder, is often recommended, but many patients are either not medically fit for the procedure or prefer to avoid its substantial impact on quality of life. ANKTIVA offers a potential bladder-preserving alternative for these patients.
How ANKTIVA Works
ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist designed to enhance the body’s immune response against cancer. Unlike immune checkpoint inhibitors that primarily remove brakes on the immune system, ANKTIVA aims to actively stimulate the expansion and activation of cytotoxic immune cells, including natural killer cells and CD8-positive T lymphocytes .
Clinical Trial Data
The approval is supported by data from the QUILT-3.032 clinical trial, which demonstrated a complete response rate of 71 percent and a median duration of response of 26.6 months in patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors . These results have been published in peer-reviewed journals, including NEJM Evidence and The Journal of Urology.
Statement from Dr. Patrick Soon-Shiong
“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. Dr. Soon-Shiong also stated on X, “Global expansion-first approval in Asia!! Anktiva now approved in Macau, China today. Paradigm change of treating the immune system unstoppable.”
Looking Ahead
While Macau has a relatively small population, this approval is strategically important as a potential entry point into the broader Asia-Pacific regulatory landscape. The real-world impact of ANKTIVA will depend on factors such as clinical adoption, reimbursement policies, and manufacturing capacity. Ongoing regulatory reviews and post-authorization experience will determine its broader integration into clinical care.