ImmunityBio Partners with Biopharma and Cigalah Healthcare to Launch ANKTIVA® in Saudi Arabia for Bladder and Lung Cancer Patients
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Key Terms
bacillus calmette-guérin (bcg)medical
Bacillus Calmette-Guérin (BCG) is a live, weakened strain of bacteria used as a vaccine against tuberculosis and as a longstanding immune-stimulating therapy for certain cancers, most commonly bladder cancer. Investors watch BCG because its supply, regulatory approvals, production capacity and clinical trial results can affect sales, treatment availability and healthcare costs—think of it like a widely used, older tool whose availability and regulatory standing can sway demand and company revenues.
non-muscle invasive bladder cancer (nmibc)medical
Non-muscle invasive bladder cancer (NMIBC) is 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 as a superficial patch on wallpaper rather than a stain that has soaked through the wall. It matters to investors because NMIBC often requires repeated treatments and monitoring, drives demand for outpatient therapies and diagnostics, and creates a sizable, ongoing market for drugs, devices, and procedures due to high recurrence and long-term care costs.
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.
checkpoint inhibitormedical
A checkpoint inhibitor is a type of medicine that helps the immune system spot and attack cancer by blocking proteins that act like brakes on immune cells. For investors, these drugs matter because clinical trial results, regulatory approvals, safety profiles and market demand can quickly change a developer’s revenue and valuation; think of them as releasing the brakes on the immune system—potentially high reward but with safety and trial-risk consequences.
metastatic non-small cell lung cancermedical
A type of lung cancer that starts in the lungs and has spread to other parts of the body; “non-small cell” describes a group of common lung tumor types that behave differently from the rarer small-cell form. It matters to investors because metastatic cases drive demand for long-term treatments, ongoing clinical trials, and regulatory decisions; think of it as a problem that’s moved beyond a single room and now requires more complex, costly solutions with large market and pricing implications.
u.s. food and drug administrationregulatory
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.
european commissionregulatory
The European Commission is the executive arm of the European Union that proposes and enforces EU laws, manages the EU budget, and represents the bloc in trade and regulatory matters. It matters to investors because its decisions on regulations, competition enforcement, approvals and fines can reshape entire industries, affect company profits and risk, and change where capital flows—much like a referee and rulemaker whose calls influence how the game is played.
saudi food and drug authority (sfda)regulatory
Saudi Food and Drug Authority (SFDA) is the national regulator that sets and enforces safety and quality rules for food, medicines, medical devices and cosmetics in Saudi Arabia. Its approvals, inspections and rules act like traffic signals for companies — green lights let products be sold and grow revenue, while delays or restrictions can limit market access, affect sales and change a company’s investment risk and value.
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
CULVER CITY, Calif.--(BUSINESS WIRE)--
ImmunityBio, Inc. (NASDAQ: 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.
