ImmunityBio signs exclusive U.S. supply agreement with Japan BCG Laboratory for Tokyo strain of BCG

ImmunityBio, Inc.

Agreement grants ImmunityBio exclusive U.S. rights to develop and commercialize Tokyo-172 BCG for 10 years after FDA approval.
Positive Phase III SWOG S1602 trial demonstrated non-inferiority of Tokyo strain vs TICE BCG in high-grade NMIBC (HR 0.82; 95.8% CI 0.63–1.08).
ImmunityBio plans to engage FDA for BLA submission as sole applicant; no payment due until FDA approval; vials for regulatory submission provided at no cost.
Agreement provides second BCG source alongside Serum Institute's rBCG; rBCG remains available to eligible patients under FDA Expanded Access Program.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.95

ImmunityBio, Inc. entered into Exclusive Development and Supply Agreement with Japan BCG Laboratory valued at No payment due prior to FDA approval; minimum 2 batches per year after approval (effective 2026-05-14).

Action: entry
Agreement: supply
Counterparty: Japan BCG Laboratory
Value: No payment due prior to FDA approval; minimum 2 batches per year after approval
Effective: 2026-05-14

Exact text from the filing

On May 14, 2026, ImmunityBio, Inc., a Delaware corporation (“ImmunityBio” or the “Company”), entered into an exclusive development and supply agreement (the “Agreement”) with Japan BCG Laboratory, a Japanese corporation (“JBL”).

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Source: SEC EDGAR

accession 0001193125-26-229153

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