IASO Bio Announces Approval of New Drug Application for Equecabtagene Autoleucel by the Macau Pharmaceutical Administration Bureau

SHANGHAI, NANJING, China and SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) has approved the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent.

This is the first NDA approval for Equecabtagene Autoleucel outside Mainland China. Equecabtagene Autoleucel (trade name: FUCASO) was approved by China's National Medical Products Administration (NMPA) on June 30, 2023, for treating adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent. On January 29 and February 14, 2025, the NDA for this product for the above indications was formally accepted by the Health Sciences Authority of Singapore and the Department of Health of Hong Kong, China, respectively.

The Macau NDA approval is based on data from the pivotal FUMANBA-1 trial (CTR20192510, NCT05066646), a China-based, multi-site, Phase I/II registrational study evaluating the efficacy and safety of equecabtagene autoleucel in patients with relapsed/refractory multiple myeloma (R/R MM). The results demonstrated that equecabtagene autoleucel achieves outstanding efficacy and a favorable safety profile.

Ms. Zhang Jinhua, Founder, Chairperson, and CEO of IASO Biotherapeutics, stated: 
"We are delighted that the New Drug Application (NDA) for equecabtagene autoleucel has been approved by the Macau Drug Administration—the product's first NDA approval outside Mainland China, marking a significant milestone. Through our innovative 'Manufactured in Nanjing, Supplied Globally' model, we will ensure timely access to this CAR-T therapy for multiple myeloma patients in Macau.

In December last year, we successfully delivered our Nanjing-manufactured CAR-T therapy to patients in Hong Kong through the Named Patient Program (NPP). Subsequently, in January and February of this year, the NDAs for equecabtagene autoleucel were officially accepted by the Singapore Health Sciences Authority and the Hong Kong Department of Health, respectively. We are actively collaborating with regulatory authorities to advance the approval processes and look forward to delivering clinical benefits to patients in these regions at the earliest opportunity. Meanwhile, IASO Bio remains committed to expanding the global footprint of our CAR-T therapies, dedicated to providing more treatment options for multiple myeloma patients worldwide."

About Multiple Myeloma（MM)

Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses.

About Equecabtagene Autoleucel

Equecabtagene Autoleucel is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, FUCASO demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses, providing continuous protection and care for patients with multiple myeloma.

About IASO Bio

IASO Bio Founded in 2017, IASO Bio is a leading biopharmaceutical company specializing in the discovery, development, manufacturing, and commercialization of cutting-edge cell therapies and biologics. Initially focused on treatments for blood cancers, the company has strategically expanded into autoimmune diseases.

IASO Bio boasts a robust drug development platform, encompassing early discovery to clinical trials, regulatory approval, and commercialization. The company is advancing a diverse pipeline of over 10 innovative products. Notably, Equecabtagene Autoleucel (FUCASO), the world's first fully human CAR-T therapy developed by IASO Bio was approved by Chinese National Medical Products Administration (NMPA) in June 2023 for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent. relapsed/refractory multiple myeloma (R/RMM) in patients at the fourth line and beyond. This product is also in Phase III clinical trials for second and third-line multiple myeloma (MM) and has received Investigational New Drug (IND) approvals in both China and US for autoimmune diseases. Meanwhile, the dual-target (CD19/CD22) product, CT120, for lymphoma is entering Phase II clinical trials. Additionally, RD118, another product targeting GPRC5D for the treatment of R/R MM, has received IND approval in China.

In addition to CAR-T therapies, IASO Bio is advancing IASO-782, a fully human anti-CD19 monoclonal antibody. This product has secured IND approvals in China and USA for several autoimmune diseases, with plans to explore additional autoimmune indications.

IASO Bio has established multiple global collaborations and licensing agreements with leading cell therapy companies, such as Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, underscoring its superior technology platform and commitment to next-generation cell therapies.

With a strong management team, a robust pipeline, high-standard manufacturing and advanced clinical development capabilities, the company is well-positioned to drive innovation. It remains committed to accelerating the development of transformative therapies that address unmet medical needs for patients worldwide. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

SOURCE IASO Bio