• ImmunityBio entered an exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 strain of BCG, securing rights to develop, import, and commercialize intravesical Tokyo-172 BCG in the U.S.
• The deal adds a second potential BCG supply source as the company seeks to address a long-running U.S. shortage for bladder cancer treatment.
• Regulatory work will be led by ImmunityBio, which plans to engage the FDA and file a biologics license application as the sole applicant and marketing authorization holder if the product is cleared.
• The partnership leans on a positive Phase III SWOG S1602 readout disclosed in February 2026 that showed Tokyo-172 BCG was non-inferior to TICE BCG in BCG-naive high-grade non-muscle invasive bladder cancer, with a hazard ratio of 0.82.
• Tokyo-172 BCG remains investigational in the U.S. and is not FDA-approved.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immunitybio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260516297941) on May 16, 2026, and is solely responsible for the information contained therein.