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ImmunityBio announced a partnership with Biopharma and Cigalah Healthcare on February 20, 2026, to launch ANKTIVA for bladder and lung cancer patients in Saudi Arabia, where the immunotherapy received regulatory approval the previous month. The biotechnology company established a wholly owned subsidiary in the kingdom to oversee distribution and commercialization across the MENA region, with product availability expected within 60 days. ANKTIVA will target BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ in combination with BCG as well as metastatic non-small cell lung cancer when used with checkpoint inhibitors after disease progression on prior therapies.
ImmunityBio said in a statement that the agreement with the two largest pharmaceutical commercial distributors in the MENA region positions the therapy for rapid introduction to address significant unmet needs. Biopharma is headquartered in Dubai while Cigalah Healthcare, founded in 1987 in Jeddah, has grown into one of the fastest-expanding distributors in Saudi Arabia and the Middle East. The partnership follows Saudi Food and Drug Authority approval of ANKTIVA in January 2026 for both indications, building on its earlier clearances in other markets.
The Saudi FDA granted the approval for BCG-unresponsive NMIBC with carcinoma in situ with or without papillary disease based on data from the QUILT-3.032 trial, according to a separate regulatory announcement from the company in January. For non-small cell lung cancer, the accelerated approval applies to patients with metastatic disease that progressed after standard treatment including immune checkpoint inhibitors, with use limited to those having absolute lymphocyte count of at least 1,000 per microliter. ANKTIVA first gained U.S. FDA approval in April 2024 for the bladder cancer indication, followed by United Kingdom MHRA clearance in July 2025 and European Union conditional approval in February 2026.
ANKTIVA, a first-in-class IL-15 agonist IgG1 fusion complex, activates natural killer cells, CD8-positive T cells and memory T cells while overcoming tumor escape mechanisms by mimicking membrane-bound IL-15, the company stated in the February announcement. It is administered intravesically for bladder cancer and is not approved for intravenous or subcutaneous use. The therapy carries a warning that delaying cystectomy in patients with bladder cancer unresponsive to BCG plus ANKTIVA may increase the risk of metastatic disease.
Lung cancer represents a major health challenge in Saudi Arabia, where it is the third most common cancer among males over age 45, according to a 2025 analysis in the Journal of Epidemiology and Global Health that drew on data from the Saudi Cancer Registry between 2015 and 2020. The burden of bladder cancer has also risen across the MENA region between 1990 and 2021, though the increase did not reach statistical significance, a separate 2025 study published in the journal Urology Annals reported. These trends underscore the demand for additional treatment options in a region where cancer incidence continues to climb amid demographic shifts and lifestyle changes.
In the statement, ImmunityBio President and CEO Richard Adcock said, “We are pleased to partner with two of the largest pharmaceutical commercial distributors in the MENA region to launch ANKTIVA to patients in Saudi Arabia and throughout the region.” Biopharma General Manager Tamer Eissa added that the goal is to ensure patients have access to the most advanced therapies to help extend lives of those with bladder and lung cancer. ImmunityBio Founder Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong noted that meetings with the Saudi FDA and other authorities had been highly productive and collaborative.
Discussions remain underway with Saudi and UAE regulatory bodies to expand ANKTIVA indications beyond the current approvals for bladder and lung cancers, the company indicated in its February 20 release. The launch forms part of ImmunityBio’s broader effort to commercialize the product in additional international markets after securing approvals in the United States, United Kingdom and European Union. Further details on the partnership and regulatory filings are available in the company’s SEC documents from March and November 2025.
