Shanghai-based IASO Bio announced that the Clinical Trial Notification for its fully human-derived BCMA-targeted CAR-T cell therapy has received implicit approval in Japan, making it the first CAR-T therapy from China to independently enter the Japanese market.
Zhang Jinhua, founder, chairman, and CEO of IASO Bio, described the approval as a key milestone in the company’s globalization strategy. “It not only affirms the clinical value of the product but also provides a clear pathway for advancing global development based on data generated in China,” she said.
The registration and submission process was fully supported by the ULab Seaknit Kobe Joint Laboratory, established by Shanghai United Development Consulting Co Ltd, a Waigaoqiao Group company, and Seaknit Biotechnology Co Ltd. The lab was inaugurated on January 10, 2025, with a focus on providing one-stop solutions to support Chinese biopharmaceutical companies in bringing innovative drug pipelines to Japan. IASO Bio’s successful entry into Japan marks one of the lab’s first major achievements.
The Waigaoqiao Bonded Zone, one of China’s first pilot zones allowing foreign-invested enterprises to conduct R&D and production in stem cell and gene therapy technologies, offers comprehensive policy support for the cell and gene industry, including customs facilitation and clinical trial coordination.
In May 2025, IASO Bio also announced the opening of its global R&D center in Waigaoqiao. The 32,000-square-meter facility will leverage the bonded zone’s unique advantages to advance cutting-edge cell and gene therapy technologies.
