IASO Bio Announces Singapore HSA Acceptance of NDA for Equecabtagene Autoleucel (FUCASO®), a First-in-Class Fully Human Anti-BCMA CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
IASO Biotechnology
Cancer Treatment New Drug Developer
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On January 29, IASO Bio announced,Singapore's Health Sciences Authority (HSA) has officially accepted the New Drug Application (NDA) for IASO Bio's CAR-T cell product, Equecabtagene Autoleucel Injection (FUCASO), for the treatment of adult patients with relapsed/refractory multiple myeloma (R/RMM) who have progressed after at least three prior lines of therapy.。
On June 30, 2023, the injection of Idecabtagene Vicleucel (Trade name in mainland China: Focusa®) was approved for marketing by the National Medical Products Administration (NMPA) of China. It is used to treat 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 an immunomodulatory agent). As the world's first commercially available fully human CAR-T product, since the approval and launch of Focusa®, its remarkable efficacy and safety have not only gained recognition from clinical experts and patients in China but also attracted patients from more than ten countries and regions worldwide to come to China for this treatment.
Ms. Zhang Jinhua, Founder, Chairwoman and Chief Executive Officer of IASO BioSaid: "Steadily advancing internationalization is a core strategy of IASO Bio. Singapore is the first country where we have submitted a new drug application overseas. The formal acceptance of the NDA for Ixalizumab Injection by HSA marks an important milestone in IASO Bio's 'going global' journey. Ixalizumab Injection has demonstrated breakthrough efficacy and safety both in clinical trials and in real-world settings. We will actively cooperate with HSA’s review process to expedite the drug's approval and launch in Singapore. Once the marketing application is approved, we will adopt an innovative 'produced in China, supplied overseas' model, truly enabling domestically produced autologous CAR-T drugs to go abroad."
Emerging markets have huge unmet medical needs. IASO Bio has an experienced international drug registration team and the capability to efficiently advance overseas commercialization. In the future, we plan to simultaneously initiate drug registration in multiple countries, fully accelerating the internationalization process, with the hope that this innovative therapy can benefit patients in more countries and regions around the world."
Multiple Myeloma (MM)
Multiple Myeloma (MM) is the second most common hematologic malignancy globally and in Singapore. According to Globocan data, the global incidence rate of multiple myeloma in 2022 was 1.8 per 100,000, with a 5-year prevalence rate of 6.8 per 100,000. In Singapore, the incidence rate of multiple myeloma in 2022 was 2.2 per 100,000, and the 5-year prevalence rate was 15.0 per 100,000. Despite advances in current anti-myeloma treatments, MM remains largely incurable, with frequent relapses and a tendency to develop resistance to multiple 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 existing anti-myeloma therapies to achieve deep and durable responses.
Icasolone Injection (FUCASO)
FUCASO (Equecabtagene Autoleucel Injection) is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It uses lentivirus as a gene carrier 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 stringent molecular structure screening and comprehensive in vivo and in vitro functional evaluation, Fucaso® demonstrates rapid and potent efficacy, remarkable in vivo persistence, enabling patients to achieve deep and durable remission, continuously safeguarding patients with multiple myeloma.
About IASO Bio
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 the development of hematological tumor cell drugs and expands into the fields of autoimmune diseases and antibody-based drugs, possessing comprehensive capabilities across the entire process from early drug discovery, clinical development, regulatory submission to commercialization.
The company currently has more than 10 innovative drug candidates at various stages of development. Among them, the world's first fully human CAR-T product independently developed by IASO Bio, Idecabtagene Vicleucel Injection (Focuxin®), which targets BCMA, was approved for marketing by the China National Medical Products Administration (NMPA) in June 2023. It is used to treat 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 front-line indication for treating 2-3 line multiple myeloma (MM) has entered Phase III clinical trials. In addition, Idecabtagene Vicleucel Injection has received multiple Investigational New Drug (IND) approvals in China and the United States for autoimmune diseases. Meanwhile, CT120, a dual-target (CD19/CD22) product 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, IASO Bio's fully human anti-CD19 antibody product, IASO-782, has received IND approval in China and the United States for the treatment of multiple autoimmune diseases, with further indications in autoimmune diseases still under exploration.
Source: IASO Bio