CD8A

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 or . 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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 . 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SHANGHAI and NANJING, China and SAN JOSE, Calif., Jan. 29, 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 Singapore Health Sciences Authority (HSA) 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 the treatment of 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 or its remarkable efficacy and safety since its launch. Furthermore, it has also attracted patients from over ten countries to China to receive this innovative therapy. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, stated, "Expanding our global footprint is a core strategy for IASO Bio. Singapore is the first country where we have submitted an overseas NDA. The official acceptance of the NDA for Equecabtagene Autoleucel by the HSA marks a significant milestone in our journey to 'go global.' Equecabtagene Autoleucel has demonstrated outstanding efficacy and safety in both clinical trials and real-world settings. We will actively cooperate with the HSA throughout the regulatory process and strive to expedite the launch of this CAR-T therapy in Singapore. Upon NDA approval, we plan to implement an innovative model of 'Manufactured in China, supplied overseas', enabling the export of domestically produced autologous CAR-T therapies to other countries. There is significant unmet medical need for CAR-T therapy in emerging markets. We have an experienced regulatory team for international registration and possess the capability to efficiently advance our overseas commercialization efforts. As the next step, we plan to initiate registration in multiple countries simultaneously to accelerate our global expansion.. We hope that this innovative therapy will benefit patients in more countries worldwide." About Multiple Myeloma （ MM) Multiple myeloma (MM) is the second most common hematological malignancy in Singapore as well as 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. In Singapore, the incidence of MM in 2022 was 2.2 per 100,000 people, with a 5-year prevalence of 15.0 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 FUCASO(Equecabtagene Autoleucel) 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 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 . SOURCE IASO Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED