First lentiviral-vector-based in vivo CAR-T product from China to receive a U.S. FDA IND clearance; a Phase Ib study in R/R B-NHL will be initiated directly in the United States

IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that its Investigational New Drug (IND) application for IASO208, a CD20-targeting in vivo CAR-T therapy developed on the company's proprietary InTelliCAR™ platform, has been approved by the National Medical Products Administration (NMPA) of China. This follows the implicit clearance of the IASO208 IND by the U.S. Food and Drug Administration (FDA) in September 2026. As the first lentiviral-vector-based in vivo CAR-T product from China to receive an FDA IND clearance, IASO208 will build on investigator-initiated trial (IIT) data generated in China to initiate a Phase Ib clinical study directly in the United States, targeting adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

The approval of the China IND marks the formal entry of IASO's InTelliCAR™ platform into a phase of synchronized U.S.–China clinical development, and further validates the feasibility of leveraging China's early clinical data to support global registrational development. IASO208 is the company's first product to obtain IND approval through China's 30-day expedited review pathway. This not only reflects regulatory recognition of the scientific merit of IASO208, but also demonstrates that IASO has established mature, end-to-end capabilities across the full development value chain for in vivo CAR-T products—spanning chemistry, manufacturing and controls (CMC), nonclinical studies, clinical trial design, and communication with regulatory authorities.

IASO208 is currently being evaluated in an investigator-initiated, single-arm, open-label, dose-exploration study designed to assess its safety, tolerability and preliminary efficacy in patients with relapsed/refractory B-cell malignancies. In this study, patients are not required to undergo conventional apheresis or lymphodepleting conditioning and receive a single intravenous infusion of IASO208. To date, 11 patients have been dosed. Early data have demonstrated favorable tolerability and promising anti-tumor activity, laying a solid foundation for larger, more systematic clinical studies to be conducted in both China and the United States. The early results of this study have been selected for an Oral Presentation at the 2026 American Society of Hematology (ASH) Annual Meeting (Abstract :#705).

Ms. Jinhua Zhang, Founder, Chairperson and Chief Executive Officer of IASO Bio，stated:"The approval of the China IND for IASO208 is another milestone for IASO's proprietary in vivo CAR-T platform, InTelliCAR™, following our receipt of FDA IND clearance. It marks a decisive step for this product—the first lentiviral-vector-based in vivo CAR-T from China to receive an FDA IND clearance—from 'U.S. IND approval' toward 'synchronized U.S.–China clinical development.' Leveraging the InTelliCAR™ platform, IASO has assembled a portfolio of in vivo CAR-T product candidates across hematologic malignancies, autoimmune diseases and solid tumors, with several candidates now in the IND-enabling stage. The launch of synchronized U.S.–China clinical development for IASO208 lays a critical foundation for the global expansion of the InTelliCAR™ platform. Looking ahead, IASO will accelerate the global clinical development of IASO208 so that this China-originated, innovative in vivo CAR-T product can reach and benefit an even broader patient population worldwide at an earlier date."