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Korea Herald
10-07-2025
- Business
- Korea Herald
IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel
SHANGHAI, NANJING, China and SAN FRANCISCO, July 9, 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 its self-developed anti-BCMA CAR-T cell therapy product, Equecabtagene Autoleucel (Fucaso), has been granted Orphan Drug Designation (ODD) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Currently, the Korean MFDS adopts a dual standard for orphan drug designation: 1. Drugs used for diseases with a domestic patient population (prevalence) of 20,000 or fewer; 2. Drugs used for diseases for which appropriate treatment methods or drugs have not been developed, or drugs that demonstrate significantly improved safety or efficacy compared to existing alternative drugs. For orphan drugs that are "available abroad but not domestically", South Korea has policies to facilitate their import*. Following ODD, the registration and approval process of Equecabtagene Autoleucel Injection in South Korea is expected to be accelerated, potentially enabling earlier access for local patients. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, stated: "The Orphan Drug Designation granted to Equecabtagene Autoleucel Injection in South Korea marks another significant international regulatory milestone for the product, following its ODD approval in Saudi Arabia in May. This Designation is expected to accelerate patient access to this CAR-T therapy in South Korea. IASO Bio is implementing its global registration strategy of 'parallel multi-country submissions with regional synergy'to obtain approvals for this innovative cell therapy in additional countries and regions, ultimately extending its benefits to a wider patient population." 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（Fucaso） Equecabtagene Autoleucel（Fucaso） 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 domain, and 4-1BB co-stimulatory molecule 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 deep and durable remission,providing continuous protection and care for patients with multiple myeloma. About IASO Bio IASO Bio is a biopharmaceutical company focused on the discovery and development of innovative cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization. Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022. Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit or
Yahoo
14-02-2025
- Business
- Yahoo
IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health
SHANGHAI and NANJING, China and SAN JOSE, Calif., Feb. 14, 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 Hong Kong Department of Health (DOH) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies. 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. As the world's first commercialized fully human CAR-T product, FUCASO has gained recognition from healthcare professionals and patients in China for its remarkable efficacy and safety since its launch. Furthermore, it has also attracted patients from over ten regions/countries to China to receive this innovative therapy. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, stated: "We are delighted that the New Drug Application for Equecabtagene Autoleucel has been officially accepted by the Hong Kong Department of Health. Hong Kong occupies a 'frontline position' for biopharmaceutical companies in mainland China to expand into global markets, making it a key step in IASO Bio's journey to 'go global.' Thanks to the latest '1+' Mechanism introduced by the Hong Kong Department of Health, we swiftly submitted the NDA. This not only demonstrated our regulatory team's in-depth understanding of and swift response to drug regulatory policies in different regions and countries, but also marks our first successful practice in adopting a flexible and localized registration strategy. We will actively collaborate with the DOH throughout the regulatory process and strive to expedite the launch of this CAR-T therapy in Hong Kong. Fully believing in the outstanding clinical value of Equecabtagene Autoleucel, we have also submitted NDAs in other regions and countries. We remain committed to accelerating access to advanced CAR-T therapies for patients around the world." 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（FUCASO） FUCASO (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 CD3ζ activation 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 or View original content: SOURCE IASO Bio Sign in to access your portfolio
