ImmunityBio Gains Strategic Foothold in Saudi Pharmaceutical Market
17.02.2026 - 22:54:05
ImmunityBio has secured a significant opportunity to expand its commercial reach in the Middle East. The company's shares saw positive momentum following news of a regulatory breakthrough with the Saudi Food and Drug Authority (SFDA).
A key development stems from an acute shortage in Saudi Arabia of Bacillus Calmette-Guérin (BCG), a long-established immunotherapy for bladder cancer. Operating within the framework of the Saudi-USA Biotech Alliance, the SFDA has formally requested that ImmunityBio submit a marketing application for its recombinant BCG (rBCG) product. The biotech firm has confirmed it will provide the complete documentation promptly.
In parallel, discussions have advanced regarding the broader use of ImmunityBio's flagship therapy, ANKTIVA. Saudi regulators have expressed openness to evaluating ANKTIVA in combination with checkpoint inhibitors across a range of tumor types, which represents a potential expansion beyond its current approved indications.
Building on an Existing Foundation
This prospective market growth is supported by a recent regulatory success. In January 2026, ANKTIVA received an accelerated approval in Saudi Arabia for treating metastatic non-small cell lung cancer in patients whose disease has progressed following standard therapies.
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Current Saudi Approvals for ANKTIVA:
* BCG-unresponsive non-muscle invasive bladder cancer
* Metastatic non-small cell lung cancer post prior therapy
Clinical evidence from the QUILT-3.055 trial indicates ANKTIVA's potential to restore the efficacy of checkpoint inhibitors in several cancer types. To manage its expanding regional operations, ImmunityBio has established a local subsidiary. This entity will oversee regulatory affairs, commercialization, and clinical development within the country.
The strategic collaboration with Saudi authorities provides the company with access to a rapidly developing healthcare market. With the anticipated rBCG application and ongoing talks about label expansions for ANKTIVA, ImmunityBio's commercial footprint in the region is poised for potential growth.
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