IASO Biotechnology's In Vivo CAR-T Product IASO208 Receives NMPA Approval, Entering Simultaneous Clinical Development in China and the U.S.

In a small clinical trial room in China, eleven patients with relapsed blood cancers received a single intravenous infusion — no cell harvesting, no chemotherapy preconditioning. Just one shot. Within months, early signs suggested their tumors were shrinking.

That approach — called in vivo CAR-T — could reshape how the world treats blood cancers. And a Chinese biotech company is betting it can lead the race.

On November 11, 2026, IASO Biotechnology announced that its CD20-targeting in vivo CAR-T product, IASO208, received approval from China's National Medical Products Administration (NMPA) to begin clinical trials. The approval came just two months after the U.S. Food and Drug Administration granted IASO208 an implied IND clearance in September 2026 — making it the first lentiviral vector-based in vivo CAR-T product from China to secure FDA authorization.

The dual approvals mark a turning point for the Nanjing-based company, founded in 2017, and signal that Chinese early-stage clinical data can now support global drug development programs.

A Different Kind of CAR-T

Traditional CAR-T therapy is a logistical marathon. Doctors extract a patient's T cells, ship them to a manufacturing facility where they are genetically engineered, then infuse them back after the patient undergoes intensive chemotherapy to clear space for the new cells. The process can take weeks and costs hundreds of thousands of dollars.

IASO208, developed on IASO's proprietary InTelliCAR™ platform, works differently. The therapy is administered as a single intravenous infusion directly into the patient's body, where it engineers T cells in vivo — inside the patient. No cell collection. No preconditioning chemotherapy. No manufacturing wait.

The ongoing investigator-initiated trial (IIT) is a single-arm, open-label, dose-exploration study evaluating IASO208 in patients with relapsed or refractory B-cell malignancies. Eleven patients have been dosed so far. Early data show favorable tolerability and encouraging anti-tumor activity, according to the company.

The results were significant enough to earn an oral presentation at the 2026 American Society of Hematology (ASH) Annual Meeting (Abstract #705) — one of the most prestigious stages in hematology research.

From China to the U.S. — Simultaneously

IASO plans to leverage data from the Chinese IIT to launch a Phase Ib clinical study directly in the United States, targeting adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The NMPA approval cleared IASO208 through China's 30-day review pathway — a fast-track process reserved for drugs with strong scientific merit.

"The approval of IASO208's IND in China is another milestone for our proprietary in vivo CAR-T platform InTelliCAR™, following the FDA clearance," said Zhang Jinhua, founder, chairwoman and CEO of IASO Biotechnology. "It marks a critical step from 'FDA IND approval' to 'simultaneous clinical development in China and the U.S.'"

The NMPA approval also validates IASO's full-chain development capabilities — from CMC systems and preclinical research to clinical trial design and regulatory engagement.

A Broader Pipeline

IASO208 is just one piece of a larger strategy. IASO Biotechnology has built a pipeline of 10 marketed and investigational products, including three autologous CAR-T therapies, five in vivo CAR-T therapies, and one antibody candidate.

The company's flagship product, equecabtagene autoleucel, is already approved and marketed in China for patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy. IASO is now developing the same product for earlier-stage multiple myeloma and autoimmune diseases including myasthenia gravis (MG), multiple sclerosis (MS), and systemic lupus erythematosus (SLE)/lupus nephritis (LN).

Strategic partnerships with Innovent Biologics, Sana Biotechnology, Cabaletta Bio, and Umoja Biopharma — along with collaborations with leading academic institutions and hospitals — have expanded IASO's development reach across blood cancers, autoimmune diseases, and solid tumors.

Several additional in vivo CAR-T candidates are now advancing into IND-enabling studies, the company said.

For patients like the eleven already dosed in the IASO208 trial, the promise is simple: a one-shot therapy that could replace weeks of grueling treatment. Whether that promise holds up in larger, controlled studies across both China and the U.S. will determine whether in vivo CAR-T moves from breakthrough concept to standard of care.