IASO Bio's CAR-T Therapy, Equecabtagene Autoleucel, Advances in Hong Kong and Singapore for Multiple Myeloma
核心洞察
IASO Bio (搜索)'s Equecabtagene Autoleucel (FUCASO) NDA has been accepted by the Hong Kong Department of Health for relapsed/refractory multiple myeloma (搜索).
The CAR-T therapy, already approved in China, is the first fully human CAR-T product and has shown remarkable efficacy and safety.
Singapore Health Sciences Authority (HSA) has also accepted the NDA for Equecabtagene Autoleucel, marking a key step in IASO Bio (搜索)'s global expansion.
IASO Bio (搜索) is making strides in expanding the global reach of its innovative CAR-T therapy, Equecabtagene Autoleucel (FUCASO), for the treatment of relapsed and/or refractory multiple myeloma (搜索) (R/R MM). The Hong Kong Department of Health (DOH) and the Singapore Health Sciences Authority (HSA) have both accepted New Drug Applications (NDAs) for the therapy, marking significant milestones in the company's global expansion strategy.
Equecabtagene Autoleucel, already approved by China's National Medical Products Administration (NMPA) in June 2023, is a fully human anti-BCMA (搜索) CAR-T cell therapy. It is indicated for adult patients with R/R MM who have received three or more prior lines of therapies, including at least one proteasome inhibitor and an immunomodulatory agent.
Regulatory Milestones in Hong Kong and Singapore
The acceptance of the NDA by the Hong Kong DOH is a crucial step for IASO Bio (搜索), as Hong Kong serves as a gateway for biopharmaceutical companies in mainland China to expand into global markets. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, highlighted the significance of this achievement, stating that it demonstrates the company's regulatory team's in-depth understanding of drug regulatory policies and its ability to adopt a flexible and localized registration strategy.
Similarly, the acceptance of the NDA by the Singapore HSA marks another significant milestone in IASO Bio (搜索)'s journey to 'go global.' Singapore is the first country where IASO Bio has submitted an overseas NDA. Ms. Zhang emphasized the outstanding efficacy and safety demonstrated by Equecabtagene Autoleucel in clinical trials and real-world settings. Upon approval in Singapore, IASO Bio plans to implement an innovative model of 'Manufactured in China, supplied overseas', enabling the export of domestically produced autologous CAR-T therapies to other countries.
Addressing Unmet Needs in Multiple Myeloma Treatment
Multiple myeloma (搜索) 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. 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 advancements in anti-myeloma treatments, the disease remains largely incurable, with patients often experiencing multiple relapses and developing refractoriness to various drug classes.
Equecabtagene Autoleucel offers a new treatment option for patients with R/R MM who have exhausted other therapies. The CAR-T therapy uses lentivirus as a gene vector to transfect autologous T cells with a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζ activation domains. This design allows for rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses.
IASO Bio's Broader Pipeline and Global Strategy
IASO Bio (搜索) is a biopharmaceutical company specializing in the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics. In addition to Equecabtagene Autoleucel, the company has a diverse pipeline of over 10 innovative products, including the dual-target (CD19 (搜索)/CD22 (搜索)) product, CT120, for lymphoma (搜索), which is entering Phase II clinical trials, and RD118, another product targeting GPRC5D (搜索) for the treatment of R/R MM, which has received IND approval in China.
IASO Bio (搜索) is also advancing IASO-782, a fully human anti-CD19 (搜索) monoclonal antibody, which has secured IND approvals in China and the USA for several autoimmune diseases. The company has established multiple global collaborations and licensing agreements with leading cell therapy companies, underscoring its commitment to next-generation cell therapies and its mission to accelerate the development of transformative therapies that address unmet medical needs for patients worldwide.