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IASO Biotherapeutics’ Fucaso Approved in Macao for Relapsed Multiple Myeloma
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China-based IASO Biotherapeutics announced that the New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF). This approval marks the first NDA approval for Fucaso outside of mainland…
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IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
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China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
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IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
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China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Health Sciences Authority (HSA) of Singapore. The therapy is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM)…
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IASO Biotherapeutics’ CAR-T Therapy Fucaso Gets FDA Green Light for Lupus Treatment
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IASO Biotherapeutics, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis…
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China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus…
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IASO Biotherapeutics’ CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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China-based IASO Biotherapeutics has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
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Innovent Biologics and IASO Biotherapeutics Amend Partnership, Focusing on CAR-T Therapy Fucaso
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced a new set of agreements with IASO Biotechnology, a domestic firm, to adjust the terms of their earlier partnership. According to the new deals, IASO will acquire from Innovent its rights to the BCMA-targeted chimeric antigen…
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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
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China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.…
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IASO Biotherapeutics Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
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China-based IASO Biotherapeutics has received clinical trial approval from the National Medical Products Administration (NMPA) for its BCMA-directed CAR T cell therapy, Fucaso (equecabtagene autoleucel), now indicated for the treatment of refractory systemic myasthenia gravis (MG). Originally approved for marketing in China in June 2022 for recurrent and refractory multiple…
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IASO Biotherapeutics and Umoja Biopharma Join Forces for Innovative Cell and Gene Therapies Development
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IASO Biotherapeutics, a China-based company, and Umoja Biopharma, a California-headquartered developer of off-the-shelf cell therapies, have announced a collaboration agreement to research, develop, and commercialize innovative in vitro and in vivo cell and gene therapies (CGTs). This collaboration expands on a previous agreement in November 2022, where the two companies…
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Innovent Biologics and IASO Biotherapeutics’ Fucaso Approved for Multiple Myeloma Treatment in China
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Innovent Biologics, Inc. (HKG: 1801) and IASO Biotherapeutics have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their jointly developed and commercialized product, Fucaso (equecabtagene autoleucel). This approval positions Fucaso as the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy approved…
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IASO Bio Receives FDA IND Approval for IASO-782 for Autoimmune Disorders
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China-based IASO Bio has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) filing for its pipeline candidate, IASO-782. This injectable drug candidate will be assessed in US clinical trials for the treatment of various autoimmune hematological disorders, including primary immune thrombocytopenia (ITP)…
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IASO Bio Raises RMB 500 Million in Series C1 Funding for Cell Therapy Pipeline
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China-based IASO Biotherapeutics has announced the completion of a nearly RMB 500 million (USD 73.7 million) Series C1 funding round. The round was led by Shanghai Guoxin Investment & Development, Efung Capital, Shanghai Waigaoqiao Free Trade Zone Group, Nanjing Jiangbei New Area State-owned Asset Management, Housen Care Brothers, and Hongcheng…
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Legend Biotech’s Carvykti Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend Biotech Corporation (NASDAQ: LEGN) for its BCMA-directed chimeric antigen receptor (CAR) T cell therapy Carvykti (ciltacabtagene autoleucel) has been accepted for review. This makes Carvykti the third BCMA CAR-T therapy to be filed for marketing…
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IASO Biotherapeutics Receives FDA Approval for CT103A IND Application
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China-based IASO Biotherapeutics has announced approval from the US FDA for an Investigational New Drug (IND) application for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy CT103A (equecabtagene autoleucel). The therapy will be assessed in US-based clinical trials for relapsed/refractory multiple myeloma (r/r MM). Drug Profile and DevelopmentEquecabtagene autoleucel…
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IASO Biotherapeutics Partners with Umoja Biopharma to Evaluate iCIL Platform
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China-based biopharma IASO Biotherapeutics has announced a research agreement with US immuno-oncology company Umoja Biopharma, Inc., to evaluate Umoja’s iCIL platform with IASO’s best-in-class chimeric antigen receptors (CARs). The collaboration aims to develop off-the-shelf therapies for patients with hematological malignancies, initially focusing on acute myeloid leukemia (AML), with the goal…
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IASO Biotherapeutics Reports Positive Phase I Results for CAR-T Therapy in NMOSD
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China-based IASO Biotherapeutics has announced the interim results of a Phase I investigator-initiated-trial (ITT) for its BCMA chimeric antigen receptor autologous T (CAR-T) cell therapy equecabtagene autoleucel (CT103A) in neuromyelitis optica spectrum disorder (NMOSD). The study (NCT04561557) is the world’s first to assess a CAR-T therapy in aquaporin 4 (AQP4)-mediated…
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IASO Biotherapeutics Licenses CD19 Binder to Cabaletta Bio for Autoimmune Diseases
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China-based IASO Biotherapeutics has announced a licensing agreement with US firm Cabaletta Bio Inc. (NASDAQ: CABA), granting the latter an exclusive, worldwide license to develop, manufacture, and commercialize a clinically validated fully-human CD19 binder. The binder will be used in a product designed to modify T cells for the treatment…
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IASO Biotherapeutics’ BCMA CAR-T Therapy Approved for NMOSD in China
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China-based IASO Biotherapeutics announced that the National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for equecabtagene autoleucel (CT103A), a BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, for the treatment of neuromyelitis optica spectrum disorder (NMOSD). This marks the first global trial of a BCMA…
