Drugs / Equecabtagene Autoleucel
Equecabtagene Autoleucel
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 3 milestones | |||||
| Filed | Other | FUCASO | plasma cell myeloma | 2026-08-21 | “accepted for evaluation the Company's biological registration application to include its CAR-T cell therapy, FUCASO® (equecabtagene autoleucel)” iasobio.com ↗ |
| Filed | Other | FUCASO | plasma cell myeloma | 2025-01-29 | “today announced that the Singapore Health Sciences Authority (HSA) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel.” iasobio.com ↗ “today announced that the Hong Kong Department of Health (DOH) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel.” iasobio.com ↗ |
| Filed | China (NMPA) | — | plasma cell myeloma | 2022-06-02 | “today jointly announced that the China National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Equecabtagene Autoleucel” iasobio.com ↗ “The NMPA has accepted the New Drug Application for Equecabtagene Autoleucel for the Treatment of Relapsed and/or Refractory Multiple Myeloma in June 2022.” iasobio.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | China (NMPA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2023-02-13 | “The NMPA accepted the New Drug Application for equecabtagene autoleucel for the treatment of relapsed/refractory multiple myeloma (RRMM).” iasobio.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05698303 | May 2023 → May 2024 | plasma cell myeloma | Nanjing IASO Biotechnology Co., Ltd. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07055724 | Jul 2025 → Jun 2027 expected | AL amyloidosis | Nanjing IASO Biotechnology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06464991 | Mar 2024 → Aug 2027 expected | plasma cell myeloma | Nanjing IASO Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06902844 | Apr 2025 → Oct 2027 expected | lupus nephritis, systemic lupus erythematosus | Tongji Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2026-09-26 | Nanjing IASO Biotechnology Co., Ltd. | Results 2026 IMS | IASO Bio Presented FUCASO China Real-World Data iasobio.com ↗
FUCASO still achieved an objective response rate (ORR) of 95.9% and a complete response (CR) or stringent complete response (sCR) rate of 77.2%, with efficacy consistent with the overall cohort across the elderly, prior anti-CD38-treated, and high-risk cytogenetic subgroups. |
| 2026-09-25 | Nanjing IASO Biotechnology Co., Ltd. | Results 2026 IMS | Updated FUMANBA-1 Analysis of IASO Bio’s FUCASO Reveals That In Vivo Durable Persistence of CAR-T cells Is Associated with Sustained MRD Negativity and Delayed Disease Progression iasobio.com ↗ |
| 2026-08-21 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio's Registration Application for FUCASO® (equecabtagene autoleucel) Accepted by Australia's TGA iasobio.com ↗ |
| 2026-06-18 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces NDA Approval of Equecabtagene Autoleucel by the Singapore Health Sciences Authority (HSA) for the Treatment of Relapsed or Refractory Multiple Myeloma, Marking a Key Milestone in International Commercialization iasobio.com ↗
today announced that the New Drug Application (NDA) for its independently developed, fully human anti-BCMA CAR-T therapy Equecabtagene Autoleucel (FUCASO suspension for infusion) has been approved by the Singapore Health Sciences Authority (HSA). |
| 2026-03-24 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Has Received Clearance from Japan’s PMDA to Initiate Clinical Trial for CAR-T Therapy Equecabtagene Autoleucel in Second- or Third-Line Multiple Myeloma iasobio.com ↗ |
| 2025-12-08 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presents Updated Results for Equecabtagene Autoleucel in High-Risk Newly Diagnosed Multiple Myeloma Patients at 2025 ASH iasobio.com ↗
With a median follow-up of 27.04 months, the median PFS was not reached. |
| 2025-11-27 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of Relapsed or Refractory Multiple Myeloma iasobio.com ↗ |
| 2025-10-16 | Nanjing IASO Biotechnology Co., Ltd. | Results Cell Publishes Breakthrough Research Results of IASO Bio's Anti-BCMA CAR-T Equecabtagene Autoleucel in Autoimmune Disease Multiple Sclerosis iasobio.com ↗
Following a single infusion of Eque-cel, the following outcomes were observed: Significant efficacy : All five patients demonstrated significant improvements in EDSS scores, Nine-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) tests. |
| 2025-09-19 | Nanjing IASO Biotechnology Co., Ltd. | Results 2025 IMS | IASO Bio Highlights Three-Year Follow-Up Data of CAR-T Cell Therapy Fucaso for Multiple Myeloma Treatment iasobio.com ↗
Among 107 evaluable patients, the overall response rate (ORR) was 96.3%, including a complete or stringent complete response (CR/sCR) in 83.2%. |
| 2025-07-09 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel iasobio.com ↗
The Orphan Drug Designation granted to Equecabtagene Autoleucel Injection in South Korea marks another significant international regulatory milestone for the product, following its ODD approval in Saudi Arabia in May. |
| 2025-06-23 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio presents promising efficacy of Equecabtagene Autoleucel in patients with Multiple Sclerosis in IIT study at the 11th Congress of the European Academy of Neurology (EAN) iasobio.com ↗
The study has demonstrated that Equecabtagene Autoleucel are well tolerated and highly effective in treating progressive MS. |
| 2025-05-09 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel iasobio.com ↗
IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that its self-developed BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (FUCASO), has been granted Orphan Drug Designation (ODD) by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. |
| 2025-03-28 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces Approval of New Drug Application for Equecabtagene Autoleucel by the Macau Pharmaceutical Administration Bureau iasobio.com ↗
today announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) has approved the New Drug Application (NDA) for Equecabtagene Autoleucel . |
| 2025-02-14 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health iasobio.com ↗ |
| 2025-01-29 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Singapore Health Sciences Authority (HSA) iasobio.com ↗ |
| 2024-12-10 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented Study Findings on the Impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma with Equecabtagene Autoleucel(FUCASO) Myeloma at 2024 ASH iasobio.com ↗
The results highlighted the importance of the efficacy-to-target ratio in the treatment of multiple myeloma, emphasizing the crucial role of sustained CAR T-cell persistence, unaffected by baseline soluble B-cell maturation antigen (sBCMA) levels, to achieve optimal disease control. |
| 2024-11-08 | Nanjing IASO Biotechnology Co., Ltd. | Results JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso™) in the Treatment of Relapsed/Refractory Multiple Myeloma iasobio.com ↗
The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a a manageable toxicity. |
| 2024-09-29 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented Comparative Clinical Outcomes on the Optimal Lymphodepletion Prior to Infution of Equecabtagene Autoleucel（FucasoTM）in Patients with Relapsed Refractory Multiple Myeloma at 2024 IMS Annual Meeting iasobio.com ↗ |
| 2024-09-27 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented the Outcomes of Relapsed/Refractory Multiple Myeloma (R/RMM) Patients with Renal Impairment Treated with Equecabtagene Autoleucel（FucasoTM）at 2024 IMS Annual Meeting iasobio.com ↗ |
| 2024-08-12 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Two New Autoimmune Disease Indications iasobio.com ↗ |
| 2024-07-24 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Multiple Sclerosis iasobio.com ↗
The IND approval of Eque-cel in the treatment of MS from the FDA is another strong evidence of IASO Bio's ongoing dedication and technological advancements in the treatment of autoimmune diseases. |
| 2024-07-01 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented Clinical Data and Single-cell Analysis of Equecabtagene Autoleucel for the Treatment of Central Nervous System Autoimmunity in Oral Presentation at EAN 2024 iasobio.com ↗
The study results preliminarily demonstrated the good tolerability and safety, durable pathogenic antibody clearance, and potential clinical efficacy of Eque-cel in NMOSD. |
| 2024-05-11 | Nanjing IASO Biotechnology Co., Ltd. | Results Single-Cell Multi-Omics Analysis of IASO Bio's Equecabtagene Autoleucel in the Treatment of Autoimmune Diseases of the Central Nervous System Published in Science Immunology iasobio.com ↗
This paper focuses on the single-cell multi-omics analysis of the fully human BCMA targeting autologous CAR-T cell injection ( Equecabtagene Autoleucel, Eque-cel, R&D code: CT103A) in the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) . |
| 2024-04-05 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis iasobio.com ↗ |
| 2024-04-04 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis iasobio.com ↗ |
| 2024-03-29 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces NMPA's IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma iasobio.com ↗ |
| 2024-02-29 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio’s Equecabtagene Autoleucel for Refractory Myasthenia Gravis (MG) Case Report Published in EMBO Molecular Medicine iasobio.com ↗
B cell lineage reconstitution underlies CAR-T cell therapeutic efficacy in patients with refractory myasthenia gravis, initially demonstrated the good tolerability and safety of Eque-cel in the treatment of MG, as well as the durable clinical efficacy. |
| 2024-02-01 | Nanjing IASO Biotechnology Co., Ltd. | Results Promising Clinical Results on the World’s First Use of BCMA CAR-T to Treat Immune Mediated Necrotizing Myopathy (IMNM) Published on the Proceedings of the National Academy of Sciences (PNAS) iasobio.com ↗ |
| 2023-12-12 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio and Innovent Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023 iasobio.com ↗
The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment. |
| 2023-12-12 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and IASO Bio Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023 innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotherapeutics (“IASO Bio”), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced the latest analysis results from the FUMANBA-1 study of Equecabtagene Autoleucel for the treatment of multiple myeloma in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting. |
| 2023-09-28 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presents Updated Long-Term Follow-Up Data for BCMA CAR-T FUCASO® (Equecabtagene Autoleucel) at IMS 2023 iasobio.com ↗ |
| 2023-07-10 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio and Innovent Announce the NMPA Approval of the NDA for Equecabtagene Autoleucel, the World's First Fully-human BCMA CAR-T Therapy, for the Treatment of RRMM iasobio.com ↗ |
| 2023-07-03 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma innoventbio.com ↗ |
| 2023-07-01 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio and Innovent Updated Efficacy and Safety Clinical Data of Equecabtagene Autoleucel（BCMA CAR-T Cell Therapy）for Multiple Myeloma at the 2023 ASCO Annual Meeting iasobio.com ↗
The updated data showed long-term follow-up efficacy and safety of the phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China. |
| 2023-02-13 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA iasobio.com ↗ |
| 2022-12-22 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces U.S. FDA Approval of Clinical Trial Application for BCMA CAR-T CT103A for Relapsed/Refractory Multiple Myeloma iasobio.com ↗
today announced that the Investigational New Drug (IND) application for its BCMA CAR-T CT103A (equecabtagene autoleucel) has been approved by the U.S. Food and Drug Administration (FDA) for use in U.S. clinical trials for relapsed/refractory multiple myeloma (R/R MM). |
| 2022-08-19 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory World's First CAR-T for NMOSD Treatment, IASO Biotherapeutics' Equecabtagene Autoleucel, Receives IND Approval by NMPA iasobio.com ↗
This is the world's first IND approval for CAR-T in NMOSD treatment. |
| 2022-06-13 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio and Innovent Present Updated Data of BCMA CAR-T Cell Therapy（Equecabtagene Autoleucel）at EHA 2022 iasobio.com ↗ |
| 2022-06-02 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio and Innovent Jointly Announce the NMPA Acceptance of the New Drug Application for Equecabtagene Autoleucel for the Treatment of Relapsed and/or Refractory Multiple Myeloma iasobio.com ↗ |
| 2022-05-20 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Biotherapeutics’ Equecabtagene Autoleucel, the World’s First CAR-T for Treatment of NMOSD, Receives IND Application Acceptance by NMPA iasobio.com ↗ |
All press releases naming this drug 43 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Equecabtagene autoleucel | “Equecabtagene autoleucel (Fucaso®), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy” PMID 37658205 ↗ Sep 2023 |
| Known as | Eque-cel | “This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed...” NCT06902844 ↗2“Equecabtagene Autoleucel (eque-cel) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy” NCT06464991 ↗ “Equecabtagene Autoleucel, Eque-cel” NCT07055724 ↗ |
| Known as | Fucaso | “Equecabtagene autoleucel (Fucaso®), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy” PMID 37658205 ↗ Sep 2023 |
| Action | Deplete | “identifies and eliminates BCMA-expressing malignant and normal cells” NCT05698303 ↗ |
| Modality | Cell therapy | “autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy” PMID 37658205 ↗ Sep 2023 |