On November 11, 2026, IASO Bio announced that the New Drug Application (IND) for IASO208, a CD20-targeted in vivo CAR-T product developed on its proprietary InTelliCAR™ platform, has been approved by the National Medical Products Administration (NMPA).

Previously, the IND for IASO208 received implied approval from the U.S. Food and Drug Administration (FDA) in September 2026. As the first lentiviral vector-based in vivo CAR-T product in China to receive FDA IND clearance, IASO208 will leverage data from Investigator-Initiated Trials (IIT) in China to directly initiate a Phase Ib clinical study in the United States, intended for the treatment of adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

The NMPA IND approval marks that IASO Bio's InTelliCAR™ platform has officially entered the stage of synchronous clinical development in China and the U.S., further validating the feasibility of using early Chinese clinical data to support global regulatory development.

IASO208 is the first product from IASO Bio to receive IND approval through the 30-day clinical trial application pathway. This not only reflects the regulatory authorities' recognition of the scientific validity of IASO208 but also signifies that IASO Bio has established mature and comprehensive end-to-end development capabilities in the CMC system, non-clinical research, clinical protocol design, and communication efficiency with regulatory agencies for in vivo CAR-T products.

IASO208 is currently undergoing an Investigator-Initiated, single-arm, open-label, dose-escalation clinical trial (IIT) designed to evaluate its safety, tolerability, and preliminary efficacy in patients with relapsed/refractory B-cell malignancies. In this study, patients do not need to undergo traditional leukapheresis and lymphodepletion preconditioning; they only receive a single intravenous administration of IASO208. To date, 11 patients have been dosed. Early data preliminarily demonstrate favorable tolerability and encouraging anti-tumor activity, laying a solid foundation for subsequent, larger-scale and more systematic clinical studies in both China and the U.S. 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).

Efung Capital participated in the investment of IASO Bio in 2023. In the future, Efung will continue to leverage its deep industry resources in the healthcare sector to comprehensively empower IASO Bio, assisting it in accelerating the clinical translation and commercialization of cutting-edge therapies such as in vivo CAR-T, and driving more globally competitive, first-in-class innovative therapies to benefit patients at home and abroad as early as possible.

END

【Disclaimer】
The content of this article represents the Company's views based on currently available public information and materials provided by portfolio companies. It does not constitute any investment advice, medical advice, or guarantee of the performance of specific enterprises. Investing involves risks, and caution is required when entering the market. Readers should make independent judgments based on public information. Unauthorized reproduction or commercial use is prohibited.