IASO Bio Announces HSA Acceptance of NDA for Equecabtagene Autoleucel (FUCASO) in Singapore

Steadily advancing internationalization is a core strategy of IASO Bio. Singapore is the first country where we have submitted a new drug marketing application outside of China. The formal acceptance of the NDA for Idecabtagene Vicleucel Injection by the HSA marks an important milestone in IASO Bio's "going global" journey. Idecabtagene Vicleucel Injection has demonstrated breakthrough efficacy and safety both in clinical trials and in real-world settings. We will actively cooperate with the HSA’s review process to expedite the drug's market entry in Singapore. Once the marketing application is approved, we will adopt an innovative "produced in China, supplied overseas" model, truly realizing the export of domestically produced autologous CAR-T drugs.

Emerging markets have huge unmet medical needs. IASO Bio has an experienced international pharmaceutical 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) 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, prone to multiple relapses, and tends to develop resistance to multiple drug categories, presenting 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.

FUCASO (Equecabtagene Autoleucel Injection) 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 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, Fucaso...^®With rapid and potent efficacy, as well as remarkable persistence in the body, it can provide patients with deep and lasting relief, continuously safeguarding those with multiple myeloma.

IASO Bio, established in 2017, is a leading biopharmaceutical company dedicated to the research, production, and commercialization of innovative cell therapies.The company takes the development of hematological tumor cell drugs as its innovative cornerstone and expands into the fields of autoimmune diseases and antibody-based drugs, possessing full-process capabilities 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 (Focasor®), which targets BCMA, was approved for marketing by China's National Medical Products Administration (NMPA) in June 2023. It is indicated for the treatment of 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. Additionally, Idecabtagene Vicleucel Injection has received multiple Investigational New Drug (IND) approvals in both 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 both China and the United States for the treatment of multiple autoimmune diseases, with further indications for other autoimmune diseases still under exploration.

The company has successively reached global business development licensing or R&D collaborations with overseas cell therapy companies Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, actively exploring the development of next-generation cell therapy products.

IASO Bio, with its strong management team, innovative product pipeline, self-owned GMP manufacturing, and advanced clinical development capabilities, is committed to bringing transformative, accessible innovative therapies and the hope of a cure to patients in China and around the world.