IASO Bio’s Equecabtagene Autoleucel Secures Regulatory Green Light in Hong Kong
On February 14, 2025, IASO Biotherapeutics (IASO Bio) announced that their New Drug Application (NDA) for Equecabtagene Autoleucel, marketed as FUCASO, has been accepted by the Hong Kong Department of Health. A key development for the company, this therapy targets patients suffering from relapsed and refractory multiple myeloma who have undergone three or more prior lines of treatment.
Equecabtagene Autoleucel represents a significant innovation in biotechnology. It obtained approval from China’s National Medical Products Administration (NMPA) back on June 30, 2023, specifically for adult patients dealing with R/R MM after receiving a minimum of three prior therapies, which need to include at least one proteasome inhibitor and an immunomodulatory agent. FUCASO is distinguished as the world’s first fully human CAR-T product, and since its launch, it has been acclaimed for its safety and effectiveness, garnering interest from patients across more than ten countries.
Jinhua Zhang, the Founder and CEO of IASO Bio, expressed enthusiasm regarding the NDA acceptance. She underlined the strategic importance of Hong Kong as a vital hub for biopharmaceutical companies looking to expand into global markets. Zhang noted the recently implemented ‘1+’ mechanism by the Hong Kong Department of Health that facilitated the submission of the NDA, showcasing IASO Bio’s adaptability to various regional regulatory frameworks.
“Not only does this mark our initial foray into Hong Kong’s biopharmaceutical arena, but it also represents our broader commitment to making cutting-edge cancer treatments globally accessible,” Zhang commented. In tandem with this application, IASO Bio is also pursuing regulatory approvals in other regions to expedite the delivery of their CAR-T therapies to patients in need.
Multiple myeloma is notably recognized as the second most prevalent blood cancer worldwide, with a troubling incidence rate. Recent data suggests the global occurrence of multiple myeloma in 2022 stood at approximately 1.8 per 100,000 individuals, with a five-year prevalence of 6.8 per 100,000. Even with established treatment options, multiple myeloma remains largely incurable. The condition often leads to relapses and is characterized by its resilience to various drug categories—this renders the development of new and effective treatment avenues such as FUCASO essential.
FUCASO employs an innovative approach, utilizing a fully human anti-BCMA CAR-T cell therapy that leverages lentivirus technology to modify a patient’s own T-cells. The design incorporates advanced molecular components that enhance the therapy's effectiveness, enabling patients to achieve significant and long-lasting therapeutic responses. This development is backed by extensive preclinical and clinical evaluation, emphasizing its strong potential in improving patient outcomes.
Founded in 2017, IASO Bio is focused on pioneering advanced biopharmaceutical solutions, from discovery through to regulatory approval and commercialization. With a promising pipeline that includes over ten innovative products, the company is not only advancing CAR-T therapies but is also exploring treatments for autoimmune diseases. The strategic partnerships and licensing arrangements, including collaborations with notable firms like Sana Therapeutics and Cabaletta Bio, point to the company’s robust technological foundation and commitment to making meaningful contributions to patient care.
By continuing to champion treatments for unmet medical needs, IASO Bio exemplifies the ongoing drive for innovation within the healthcare industry. The acceptance of their NDA for Equecabtagene Autoleucel in Hong Kong marks a pivotal step in their effort to bring groundbreaking cancer therapies to a wider audience, enhancing the fight against relapsed multiple myeloma on a global scale.
Equecabtagene Autoleucel represents a significant innovation in biotechnology. It obtained approval from China’s National Medical Products Administration (NMPA) back on June 30, 2023, specifically for adult patients dealing with R/R MM after receiving a minimum of three prior therapies, which need to include at least one proteasome inhibitor and an immunomodulatory agent. FUCASO is distinguished as the world’s first fully human CAR-T product, and since its launch, it has been acclaimed for its safety and effectiveness, garnering interest from patients across more than ten countries.
Jinhua Zhang, the Founder and CEO of IASO Bio, expressed enthusiasm regarding the NDA acceptance. She underlined the strategic importance of Hong Kong as a vital hub for biopharmaceutical companies looking to expand into global markets. Zhang noted the recently implemented ‘1+’ mechanism by the Hong Kong Department of Health that facilitated the submission of the NDA, showcasing IASO Bio’s adaptability to various regional regulatory frameworks.
“Not only does this mark our initial foray into Hong Kong’s biopharmaceutical arena, but it also represents our broader commitment to making cutting-edge cancer treatments globally accessible,” Zhang commented. In tandem with this application, IASO Bio is also pursuing regulatory approvals in other regions to expedite the delivery of their CAR-T therapies to patients in need.
Multiple myeloma is notably recognized as the second most prevalent blood cancer worldwide, with a troubling incidence rate. Recent data suggests the global occurrence of multiple myeloma in 2022 stood at approximately 1.8 per 100,000 individuals, with a five-year prevalence of 6.8 per 100,000. Even with established treatment options, multiple myeloma remains largely incurable. The condition often leads to relapses and is characterized by its resilience to various drug categories—this renders the development of new and effective treatment avenues such as FUCASO essential.
FUCASO employs an innovative approach, utilizing a fully human anti-BCMA CAR-T cell therapy that leverages lentivirus technology to modify a patient’s own T-cells. The design incorporates advanced molecular components that enhance the therapy's effectiveness, enabling patients to achieve significant and long-lasting therapeutic responses. This development is backed by extensive preclinical and clinical evaluation, emphasizing its strong potential in improving patient outcomes.
Founded in 2017, IASO Bio is focused on pioneering advanced biopharmaceutical solutions, from discovery through to regulatory approval and commercialization. With a promising pipeline that includes over ten innovative products, the company is not only advancing CAR-T therapies but is also exploring treatments for autoimmune diseases. The strategic partnerships and licensing arrangements, including collaborations with notable firms like Sana Therapeutics and Cabaletta Bio, point to the company’s robust technological foundation and commitment to making meaningful contributions to patient care.
By continuing to champion treatments for unmet medical needs, IASO Bio exemplifies the ongoing drive for innovation within the healthcare industry. The acceptance of their NDA for Equecabtagene Autoleucel in Hong Kong marks a pivotal step in their effort to bring groundbreaking cancer therapies to a wider audience, enhancing the fight against relapsed multiple myeloma on a global scale.
Topics Health）
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