The 6^th China International Import Expo (CIIE) was held in Shanghai, China on November 5, 2023. Nanjing IASO Biotechnology Co., Ltd. (IASO Bio) made its debut at the CIIE with FUCASO, the world's first fully-human CAR-T, and entered into a strategic partnership with several international medical institutions, bringing hope for a cure to multiple myeloma (MM) patients worldwide. As a biopharmaceutical company that engages in the R&D, production and sales of innovative cell drugs, IASO Bio is not only developing CAR-T therapies of international standards for Chinese patients, but also actively promoting international clinical trials, demonstrating its scientific research and innovation capabilities.

The world's first fully-human CAR-T makes a significant debut

On June 30, 2023, the China National Medical Products Administration (NMPA) approved the marketing of Equecabtagene Autoleucel Injection (brand name: FUCASO) for the treatment of adult patients with relapsed or refractory multiple myeloma (r/rMM). Meanwhile, the Equecabtagene Autoleucel Injection has received the Orphan Drug Designation, as well as the Regenerative Medicine Advanced Therapy and Fast Track Designations from the U.S. Food and Drug Administration, and has been approved for clinical trials in the United States.

A single infusion of FUCASO can lead to lasting and deep remission with a favorable safety profile in patients with R/R MM who have failed multiple lines of therapy. Thanks to its unique design, FUCASO, as a fully-human CAR-T therapy, is able to persist in patients for a longer period of time, offering hope for overcoming the challenging problem of relapsed MM.

Establishing an international CAR-T diagnostic and treatment center

FUCASO has attracted patients from numerous countries around the world, including Asia, Europe, Oceania, and Africa, to come to China for treatment in just 4 months since its approval for marketing in China. Many patients in the first batch were accompanied by primary drug resistance, multiple drug resistance, and cytogenetically high risk, and after the treatment with FUCASO, they achieved complete remission and minimal residual disease negativity.

At present, several authoritative hematological malignancy treatment hospitals in China have established certified FUCASO treatment centers, and are recognized globally for their leading level of full-process management of CAR-T treatment. It is noteworthy that the cost of treatment with FUCASO in China is significantly lower than that of similar products in Europe and America, which has enhanced the accessibility of this innovative drug and benefited MM patients worldwide.

In addition, IASO Bio has established strategic partnerships with a number of international medical institutions, such as Jiahui Health, GoBroad Healthcare Group, to jointly build an international CAR-T diagnostic and treatment center to serve patients worldwide. As of now, several overseas multiple myeloma patients have come to Jiahui International Hospital for CAR-T treatment. Jiahui International Hospital has software and hardware conditions that are in line with international standards, comprehensive tumor treatment capabilities, an atmosphere of unimpeded cross-cultural communication, a comfortable environment, and a high cost-effective CAR-T therapy. Gobroad Medical Group integrates international-standard medical facilities, expertise in hematologic treatment, and multicultural communication, committed to providing a comfortable experience and cost-effective CAR-T therapy. They pursue medical excellence and technological innovation to meet patient needs.

Views of Experts

Said Professor Ma Jun, Chairman of the Supervisory Board of the Chinese Society of Clinical Oncology: "The global burden of multiple myeloma is severe, and relapse of this disease remains an unsolved clinical challenge. With its long-lasting survival and surveillance in body after infusion, FUCASO, the world's first fully-human BCMA-targeting CAR-T therapy, can offer patients with relapsed and refractory multiple myeloma who have failed multiple lines of treatment lasting and deep remission”.

Said Professor Wu Depei, Chairman of the Hematology Branch of the Chinese Medical Association: "The CAR-T cell therapy is developing rapidly, with level of CAR-T research in China among the world's forefront, and China is the country with the most registered CAR-T clinical trials globally. Doctors in China's hematological malignancy treatment centers have accumulated rich experience in CAR-T therapy”.

"FUCASO has shown encouraging efficacy and safety, and is expected to change the landscape of treatment for the patients with relapsed or refractory multiple myeloma, bringing hope for a cure to these patients,” said Professor Qiu Lugui, a member of the International Myeloma Society and Principal Investigator of the Registration Clinical Study of the Equecabtagene Autoleucel Injection in China. “It is hoped that this CAR-T therapy will bring benefits to patients worldwide.”

Company：Nanjing IASO Biotechnology Co., Ltd

Contact Person：Zhang Yuanyuan

Email：Med-service@iasobio.com

Website：https://i-connection.iasobio.com/en

Telephone：400 966 5315

City：Nanjing, China

Address：Floor 8-10, building D, Zhongdan Park, 3-1 Xinjinhu Road, Jiangbei New Area, Nanjing District, Jiangsu 210018