IASO Biotherapeutics, a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, 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 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.
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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.
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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.”
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Source – prnewswire
