ImmunityBio Partners with Biopharma and Cigalah Healthcare to Launch ANKTIVA® in Saudi Arabia for Bladder and Lung Cancer Patients
- Biopharma & Cigalah are two of the largest pharmaceutical commercial distributors in the Middle East and North Africa (MENA)
- ImmunityBio established a wholly owned subsidiary in the Kingdom of Saudi Arabia to support physicians and healthcare systems throughout the MENA region
- The Registration Certificate of Pharmaceutical Product with pricing has been issued to ImmunityBio from the Saudi FDA
- ANKTIVA will be available for distribution within the next 60 days
- Initiated discussion with Saudi FDA and UAE regulatory authorities to expand ANKTIVA indications beyond Lung and Bladder cancers
ImmunityBio, Inc. ((IBRX), a commercial-stage immunotherapy company, today announced a partnership with Biopharma and Cigalah, two of the largest and most respected healthcare commercial and distribution companies in the Middle East, to launch ANKTIVA® (nogapendekin alfa inbakicept) in Saudi Arabia and, over time, across the broader MENA region.
Under the agreement, Biopharma and Cigalah Healthcare will support the commercialization and distribution of ANKTIVA in two indications: In combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary disease; and in combination with a checkpoint inhibitor for patients with metastatic non-small cell lung cancer.
ImmunityBio has established a wholly owned subsidiary in Saudi Arabia, to support its distribution, commercialization, and growth across the Middle East and North Africa.
"We're pleased to partner with two of the largest healthcare and distribution companies to launch to ANKTIVA to patients in Saudi Arabia and, across the broader Middle East and North Africa region," said Richard Adcock, President and CEO of ImmunityBio. "Their combined world-class commercial infrastructure and proven track record in bringing innovative therapies to patients with serious diseases will help accelerate access to ANKTIVA and support our commitment to serving physicians and health systems throughout the region, including Saudi Arabia, United Arab Emirates, Qatar and Egypt."
The MENA region has significant unmet needs for the treatment of serious cancers, which are on the rise in many countries. Lung cancer is among the most prevalent cancers in Saudi Arabia and is the third most common cancer among males over 45 years of age, according to the Saudi Ministry of Health1. Lebanon has the highest incidence of bladder cancer cases globally, while Syria and Egypt also rank among the countries with the greatest burden of the disease.2
"At Cigalah and Biopharma our goal is to ensure that physicians and their patients have ready access to the most advanced therapies available for the most difficult-to-treat diseases like cancer," said Tamer Eissa, General Manager, Biopharma. "That is exactly what ImmunityBio brings with ANKTIVA, and we are pleased to partner with them to help extend the lives of bladder and lung cancer patients in Saudi Arabia, and the rest of the Middle Eastern countries we serve."
"We have just returned from a highly productive trip to the Middle East and met with the leadership of Saudi FDA and the Emirates Drug Establishment (EDE) to advance the development of ANKTIVA for expanded patient and indication access to the Middle East," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "I am highly encouraged by the collaborative engagement of the leadership of the regulatory authorities in the region and their desire to interact with ImmunityBio to expand access of the BioShield platform across multiple tumor types for their citizens. The initial approval by Saudi FDA for ANKTIVA in combination with checkpoint inhibitors, in patients with checkpoint failures in lung cancer has catalyzed the opportunity to build on Immunotherapy 2.0 across multiple tumor types with ANKTIVA as the backbone to NK cell therapy."
ANKTIVA received U.S. Food and Drug Administration approval in April 2024 for use in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. ANKTIVA was subsequently approved for the same indication by the UK Medicines and Healthcare products Regulatory Agency in July 2025 and the European Commission in February 2026, as well as the Saudi Food and Drug Authority (SFDA) in January 2026; in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer.
About ANKTIVA® (nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
Saudi Arabia Indication and Usage
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.
Non-small cell lung cancer (NSCLC):
ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alteration should have disease progression on approved therapy for these alterations, before using ANKTIVA in combination with immune checkpoint inhibitors.
This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.
Limitation of use:
Insufficient evidence of benefit for the use of ANKTIVA in combination with immune checkpoint inhibitors in NSCLC with baseline ALC < 1.0 × 10³/μL. Experience is limited to patients with a baseline absolute lymphocyte count (ALC) ≥ 1.0 × 10³/μL who are maintained above this level after treatments.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE:
ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
Please see the complete Prescribing Information for ANKTIVA® at Anktiva.com.
About ImmunityBio
ImmunityBio is a vertically integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response to create durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that sharply reduce or eliminate the need for standard high-dose chemotherapy. For more information, please visit: www.ImmunityBio.com.
About Cigalah Healthcare:
Based in Jeddah, Cigalah Healthcare is a leading pharmaceutical and healthcare distribution company and sole agent for many multinational pharmaceutical, herbal, health care, and cosmetic companies in Saudi Arabia and some other Gulf countries. Established in 1987, Cigalah Healthcare is the fastest growing health care distributor in Saudi Arabia and the Middle East.
About Biopharma Middle East and Africa:
Biopharma-mea is a regional Middle East company, headquartered in Dubai, United Arab Emirates, with offices across the Middle East countries. Since 2007, Biopharma has provided commercialization services for international biopharmaceutical companies throughout the Middle East focusing on rare and serious disease therapies.
References:
- Saudi national lung cancer epidemiology from the Saudi Cancer Registry, 2015–2020 (AlOmar & AlAbdulKader, J Epidemiol Glob Health, 2025).
- Based on 2018 GLOBOCAN cancer incidence data reported in Cancer incidence and mortality estimates in Arab countries (medRxiv, 2022).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, without limitation, our expectations regarding the anticipated commercial rollout of ANKTIVA® throughout the Kingdom of Saudi Arabia (KSA) and across the broader Middle East and North Africa (MENA) region, the projected impact of the newly formed KSA subsidiary on our commercial and distribution capabilities, the expected timing and outcomes of additional regulatory submissions and post-approval commitments, the expected benefits of the distribution partnership covering the Kingdom of Saudi Arabia and MENA region; anticipated market access, commercial performance, revenue potential, and growth opportunities; expected timelines for regulatory, launch, and commercialization activities; the ability of the parties to successfully collaborate and negotiate and execute under the agreement; and the potential impact of the relationship on the Company's long term strategic objectives.
These forward-looking statements are based on current expectations, assumptions, and projections that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, risks related to the ability to obtain and maintain required regulatory approvals; pricing, reimbursement, and market access challenges across the Kingdom of Saudi Arabia and MENA region; variability in demand or adoption by healthcare providers and patients; supply chain, manufacturing, and distribution risks; performance and compliance of our commercial partner; competitive pressures; changes in healthcare laws, regulations, or trade policies; foreign currency fluctuations; geopolitical or economic conditions in the region; and other risks related to international commercialization of an innovative biologic product.
More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on November 5, 2025 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.
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