On March 28, 2025, IASO Bio announced,Its CAR-T cell product Icaritin 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 Ixazomifene 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 and February 14, 2025, the New Drug Application (NDA) for this product targeting the aforementioned indications 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 Macao is based on the clinical research data from 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 Ixcellen injection in treating patients with relapsed/refractory multiple myeloma. The results demonstrated that Ixcellen injection has excellent efficacy and safety.
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 promptly access this CAR-T therapy.
By the end of last year, we had successfully provided cross-border drug supply to 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 officially 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 internationalization of China-produced CAR-T drugs, offering more treatment options for multiple myeloma patients 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, and the 5-year prevalence rate was 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, posing significant treatment challenges. Therefore, for the treatment of relapsed or refractory MM, there is still an urgent need for new therapeutic options beyond current anti-myeloma therapies to achieve deep and durable responses.
About Icarus Bio's Icolumab Injection (Focuxin)®）
Equecabtagene Autoleucel Injection (Focasu®) 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 comprises a fully human scFv, CD8a hinge and transmembrane domain, 4-1BB co-stimulatory molecule, and CD3ζ activation domain. Based on stringent molecular structure screening and comprehensive in vivo and in vitro functional evaluation, Focasu® demonstrates rapid and potent efficacy with remarkable in vivo persistence, enabling patients to achieve deep and durable remission, continuously safeguarding patients with multiple myeloma.
IASO Bio, established in 2017, is a leading biopharmaceutical company focusing on the research, production, and sales of innovative cell therapies. The company builds its innovation foundation on developing hematological tumor cell drugs and expands into the fields of autoimmune diseases and antibody drugs, possessing comprehensive capabilities covering the entire process from early drug discovery, clinical development, regulatory submission to commercialization. IASO Bio currently has more than 10 innovative drug candidates at different stages of development. Among them, the world's first fully human CAR-T product independently developed by IASO Bio, Ixcellen (generic name: Equecabtagene Autoleucel Injection, trade name: Focasor®), was approved for marketing by the China 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 2-3 line multiple myeloma (MM) has entered Phase III clinical trials. Additionally, Ixcellen has obtained multiple Investigational New Drug (IND) approvals in both China and the United States for various autoimmune diseases.
Simultaneously, the bispecific (CD19/CD22) product CT120 for lymphoma is about to enter Phase II clinical trials. Another product targeting GPRC5D for the treatment of relapsed or 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 clearance in both China and the United States for the treatment of several autoimmune diseases, with further exploration ongoing for additional autoimmune disease indications. The company has successively entered into global business development licensing 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, in-house GMP manufacturing, and advanced clinical development capabilities, IASO Bio is committed to bringing transformative, accessible innovative therapies and the hope of a cure to patients in China and around the world.
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