ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors
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non-muscle invasive bladder cancermedical
A form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it like a stain on wallpaper rather than damage to the wall’s studs. It matters to investors because it has different treatment, monitoring and recurrence patterns than deeper cancers, driving demand for repeated outpatient procedures, local therapies and diagnostic tests that affect revenue, trial design and pricing dynamics in healthcare markets.
carcinoma in situmedical
Carcinoma in situ is an early-stage abnormal growth where cells look cancerous but remain confined to the tissue surface and have not invaded deeper layers or spread to other parts of the body; think of it like graffiti on a wall that hasn’t cracked the plaster beneath. For investors, it matters because treatments, regulatory pathways, clinical trial outcomes and long-term costs differ greatly between contained lesions and invasive cancer, influencing market value, approval odds and liability for healthcare companies.
Bacillus Calmette-Guérinmedical
Bacillus Calmette-Guérin (BCG) is a weakened strain of a bacterium used as a vaccine against tuberculosis and as an immune-stimulating treatment for certain cancers, most notably early-stage bladder cancer. Think of it as a mild coach for the immune system that trains the body to recognize and attack disease; for investors, BCG matters because its supply, regulatory approvals, pricing, or clinical use can affect demand, company revenue, and healthcare costs.
immunotherapymedical
Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.
NKmedical
NK refers to natural killer cells, a type of immune cell that patrols the body and destroys infected or cancerous cells much like security guards removing threats. Investors care because companies developing NK‑based therapies aim to harness or enhance this natural defense to treat disease; progress, trial results, manufacturing advances, or regulatory setbacks can strongly affect a biotech firm’s value and partnership prospects.
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A T-cell is a type of immune cell that acts like a trained security guard, identifying and attacking infected or abnormal cells in the body. Investors care because many drugs and vaccines are designed to boost, redirect, or mimic T-cell activity; positive clinical results or regulatory approvals for T-cell–based therapies can drive significant changes in a company’s valuation, while safety or efficacy setbacks can hurt it.
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The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.
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The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.
Macau SAR, China regulator grants approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in patients with BCG-unresponsive NMIBC with CIS ± papillary tumors
Authorization follows a reliance-based review referencing prior FDA and EMA decisions
First ANKTIVA authorization in Asia, supporting ongoing global expansion across 34 countries and territories
CULVER CITY, Calif.--(BUSINESS WIRE)--
ImmunityBio, Inc. (NASDAQ: IBRX), today 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.”
About ANKTIVA®
ANKTIVA® (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 (IL-15) receptor agonist designed to activate and proliferate natural killer (NK) cells and CD8+ T cells. In the QUILT-3.032 study in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, ANKTIVA in combination with BCG demonstrated a complete response rate of 71%, with a median duration of response of 26.6 months.
About ImmunityBio
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding ImmunityBio’s regulatory activities in Macau and other jurisdictions; the potential pursuit, timing, and outcome of additional regulatory submissions and authorizations; the Company’s plans for potential commercial distribution; and its broader international expansion strategy for ANKTIVA.
These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described herein. Such risks and uncertainties include, among others, the determinations of regulatory authorities, including ISAF, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global health authorities; the possibility that additional data, analyses, or clinical studies may be required; risks related to manufacturing, supply, and distribution; and other factors affecting the Company’s business.
Additional information regarding these and other risks can be found under the heading “Risk Factors” in ImmunityBio’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, as well as in subsequent filings with the SEC, which are available at www.sec.gov. ImmunityBio cautions you not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statements except as required by law.
