IASO Bio Wins China IND Approval for IASO208 CAR-T

Shanghai and Nanjing, China, and Pleasanton, California, United States, November 10, 2026

NMPA Approval Advances Synchronized U.S.–China Clinical Development

The approval of the IASO208 IND marks an important step in the expansion of IASO Bio’s InTelliCAR™ platform into international clinical development. The application was approved through China’s 30-day expedited IND review pathway, making IASO208 the company’s first product to receive IND approval through this regulatory route. The NMPA decision follows the FDA’s implicit clearance of the investigational application in September 2026. With regulatory clearances in both countries, IASO Bio plans to use early clinical evidence generated through its investigator-initiated trial (IIT) in China to support further clinical evaluation in the United States. The company intends to initiate a Phase Ib clinical study in the United States involving adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma. This development strategy highlights the growing potential for biotechnology companies to use early-stage clinical research conducted in China to support broader international drug development. It also demonstrates IASO Bio’s efforts to strengthen its capabilities across chemistry, manufacturing and controls (CMC), nonclinical research, clinical trial planning and regulatory engagement. The coordinated approach is expected to support more systematic evaluation of IASO208 across both clinical development environments.

IASO208 In Vivo CAR-T Shows Early Clinical Promise

IASO208 is a CD20-targeted in vivo CAR-T therapy designed to generate CAR-T cells directly inside the patient’s body. Unlike conventional autologous CAR-T treatments, which generally require collecting a patient’s T cells through leukapheresis, modifying them outside the body and reinfusing the engineered cells, the in vivo approach uses a lentiviral vector to deliver the CAR genetic instructions directly into the patient. This approach is being investigated as a way to simplify important stages of CAR-T treatment. In the ongoing investigator-initiated clinical study in China, IASO208 is being evaluated through a single-arm, open-label, dose-exploration design to assess its safety, tolerability and preliminary antitumor activity in patients with relapsed or refractory B-cell malignancies. According to IASO Bio, 11 patients have received treatment in the study to date. Participants receive a single intravenous infusion without conventional leukapheresis or lymphodepleting conditioning. Early company-reported findings have demonstrated favorable tolerability and encouraging preliminary antitumor activity. However, these observations remain early-stage clinical findings and require confirmation through larger and more systematic studies. The initial clinical results have also been selected for an oral presentation at the 2026 American Society of Hematology (ASH) Annual Meeting, under Abstract No. 705.

InTelliCAR Platform Supports Broader Cell Therapy Innovation

The IASO208 development milestone reflects IASO Bio’s wider strategy to expand its research pipeline in hematological malignancies, autoimmune diseases and solid tumors. The company’s proprietary InTelliCAR™ platform forms an important part of its next-generation in vivo CAR-T research program. According to the company, its broader pipeline includes multiple investigational candidates, with several additional programs progressing through IND-enabling development. IASO Bio is also advancing its established CAR-T capabilities through its commercialized equecabtagene autoleucel program, which is approved in China for eligible patients with relapsed or refractory multiple myeloma. The company has developed an integrated infrastructure covering drug discovery, nonclinical research, clinical development, manufacturing and commercialization. These capabilities are expected to support the advancement of its next-generation cell therapy candidates into clinical evaluation. Founder, Chairperson and Chief Executive Officer Jinhua Zhang described the NMPA approval as another major milestone for the company’s proprietary in vivo CAR-T platform following its U.S. regulatory clearance. She emphasized that synchronized clinical development in China and the United States provides an important foundation for the global expansion of IASO208. Overall, the NMPA IND approval represents a significant regulatory and clinical development milestone for IASO Bio. By combining early clinical research from China with regulatory clearances in both China and the United States, the company is preparing to advance IASO208 into broader clinical evaluation. The development of in vivo CAR-T technology could offer new possibilities for simplifying cell therapy delivery, although further clinical studies will be essential to establish its safety, efficacy and long-term therapeutic potential. The progress of IASO208 highlights the growing role of biotechnology innovation in advancing next-generation cancer treatments.

Source: IASO Bio press release