Iaso Bio's CAR-T Therapy Equecabtagene Autoleucel (Fukesu®) Receives First Overseas Approval in Macao for Relapsed/Refractory Multiple Myeloma

Mar 28, 2025 11:04 CST Updated 11:04

IASO Biotechnology

Cancer Treatment New Drug Developer

On March 28, 2025, IASO Bio announced,Its CAR-T cell product Icaroselle Injection (Focuxin)^®`, equecabtagene autoleucel) has been approved by the Macao Drug Administration of China for its New Drug Application (NDA)`, for the treatment of adult patients with relapsed or refractory multiple myeloma (R/RMM) who have experienced disease progression after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).

This is the first overseas NDA approval for IASO Bio's Equecabtagene Autoleucel Injection.On June 30, 2023, the injection of Ixazomib Citrate was approved for marketing by the China National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/RMM) who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent). On January 29, 2025, and February 14, 2025, the New Drug Application (NDA) for this product targeting the aforementioned indication was officially accepted by the Health Sciences Authority of Singapore and the Department of Health of Hong Kong, China, respectively.

The approval of the NDA in the Macao region this time is based on the clinical research data of FUMANBA-1 (CTR20192510, NCT05066646). FUMANBA-1 is a multi-center Phase I/II registrational clinical study conducted in China to evaluate the efficacy and safety of Icaritin Cell Injection in treating patients with relapsed/refractory multiple myeloma. The results of this study demonstrate that Icaritin Cell Injection exhibits excellent efficacy and safety.

Ms. Zhang Jinhua

Founder, Chairman and Chief Executive Officer of IASO Bio

We are very pleased that the new drug application (NDA) for Ixcell-CAR Injection has been approved by the Macao Drug Administration. This marks the first approval of an overseas NDA for this product, representing a significant milestone. Through the innovative model of 'produced in Nanjing, supplied overseas', we will ensure that patients with multiple myeloma in the Macao region can access this CAR-T therapy in a timely manner.

By the end of last year, we had successfully implemented cross-border drug supply for patients in the Hong Kong region through the Named Patient Program (NPP). In January and February this year, the New Drug Application (NDA) for Idecabtagene Vicleucel Injection was formally accepted by the Health Sciences Authority of Singapore and the Department of Health of Hong Kong, China, respectively. We are currently fully cooperating with local regulatory authorities to advance the registration and approval process, striving to bring clinical benefits to patients in these regions as soon as possible. Meanwhile, IASO Bio will continue to promote the international expansion of CAR-T drugs produced in China, providing more treatment options for patients with multiple myeloma worldwide.

About Multiple Myeloma (MM)

According to Globocan data, the global incidence rate of multiple myeloma (MM) in 2022 was 1.8 per 100,000, with a 5-year prevalence rate of 6.8 per 100,000. Despite advances in current anti-myeloma treatments, MM remains largely incurable and is prone to multiple relapses and the development of resistance to various drug classes, presenting significant treatment challenges. Therefore, for the treatment of relapsed or refractory MM, there is still an urgent need for new therapeutic options beyond existing anti-myeloma therapies to achieve deep and durable responses.

About Icarus Bio's Icolumab Injection (Focuxin)^®）

Equecabtagene Autoleucel Injection (Focasor®) is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It uses lentivirus as a gene vector to transfect autologous T cells. The CAR includes a fully human scFv, CD8a hinge and transmembrane region, 4-1BB co-stimulatory molecule, and CD3ζ activation domain. Based on rigorous molecular structure screening and comprehensive in vivo and in vitro functional evaluation, Focasor® demonstrates rapid and potent efficacy with remarkable persistence in vivo, enabling patients to achieve deep and sustained remission, continuously safeguarding patients with multiple myeloma.

About IASO Bio

IASO Bio, established in 2017, is a leading biopharmaceutical company specializing in the research, production, and commercialization of innovative cell therapies. The company builds its innovation foundation on the development of hematological tumor cell-based drugs and expands into autoimmune diseases and antibody-based therapeutics, possessing comprehensive capabilities across the entire process from early drug discovery, clinical development, regulatory submission to commercialization. IASO Bio currently has over 10 innovative drug candidates at various stages of development. Among them, the world’s first fully human CAR-T product, Ixalocel (brand name: Focasol®), which targets BCMA, was approved for marketing by China's National Medical Products Administration (NMPA) in June 2023. It is indicated for treating adult patients with relapsed or refractory multiple myeloma (R/RMM) who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent). Its frontline indication for treating 2nd- to 3rd-line multiple myeloma (MM) has entered Phase III clinical trials. Additionally, Ixalocel has received multiple Investigational New Drug (IND) approvals in both China and the United States for various autoimmune diseases.

At the same time, the dual-target (CD19/CD22) product CT120 for lymphoma is about to enter Phase II clinical trials. Another product targeting GPRC5D for the treatment of relapsed and refractory multiple myeloma, IASO118, has received IND approval in China. In addition to cell therapy products, the company's fully human anti-CD19 antibody product, IASO-782, has received IND approval in both China and the United States for the treatment of multiple autoimmune diseases, while still exploring additional indications for autoimmune diseases. The company has successively reached global commercial expansion licenses or research collaborations with overseas cell therapy companies Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, actively exploring the development of next-generation cell therapy products. Relying on its strong management team, innovative product pipeline, self-owned GMP manufacturing, and advanced clinical development capabilities, IASO Bio is committed to bringing transformative, accessible innovative therapies and hope for a cure to patients in China and around the world. For more information, please visit the company’s official website: www.iasobio.com or LinkedIn page: www.linkedin.com/company/iasobiotherapeutics.