Drugs / Eque-cel
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | FUCASO | relapsed/refractory diffuse large B-cell lymphoma | 2025-01-29 | “Singapore Health Sciences Authority (HSA) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel.” iasobio.com ↗ “Hong Kong Department of Health (DOH) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel.” iasobio.com ↗ |
| Filed | China (NMPA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2022-06-02 | “China National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Equecabtagene Autoleucel” iasobio.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07510100 | May 2026 → Aug 2029 expected | refractory plasma cell neoplasm | Nanjing IASO Biotechnology Co., Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Nanjing, China, August 20, 2026 — IASO Bio (the "Company") today announced that Australia's Therapeutic Goods Administration (TGA) has accepted for evaluation the Company's biological registration application |
| 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 ↗
The data demonstrate that Eque-cel can provide deep and durable responses while maintaining a manageable safety profile for this patient population. |
| 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 ↗
today announced that the Biologics License Application (BLA) for its independently developed fully human anti-BCMA CAR-T therapy Fucaso (Equecabtagene Autoleucel) has been approved by the Hong Kong Department of Health. |
| 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 ↗
today announced that the Cell published results from the study evaluating its independently developed fully human anti-BCMA CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel), for the treatment of progressive multiple sclerosis (PMS). |
| 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 109 patients who received Eque-cel, the median progression-free survival (PFS) was 30.5 months, extending to 35.9 months in CAR-T–naïve patients. |
| 2025-09-12 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio to Present Promising Findings on Equecabtagene Autoleucel for Multiple Sclerosis at both ANA and ECTRIMS 2025 iasobio.com ↗
The data will be disclosed through a poster presentation and an oral presentation respectively at these two premier academic conferences. |
| 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 ↗
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 ↗
This is the first NDA approval for Equecabtagene Autoleucel outside Mainland China . |
| 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. |
| 2024-09-29 | 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 ↗
Results indicate that Eque-cel can improve the renal function for R/RMM patients with renal impairment . |
| 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 ↗
This is the fifth IND approval obtained for Eque-cel for autoimmune diseases in China and the United States. |
| 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 ↗
This is the second FDA IND approval of Eque-cel for the treatment of autoimmune diseases in 2024, following refractory generalized myasthenia gravis (gMG). |
| 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. |
| 2024-06-16 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented New Data of FUCASO® (Equecabtagene Autoleucel) for the Treatment of High-risk Newly Diagnosed Multiple Myeloma in Oral Presentation at EHA 2024 iasobio.com ↗ |
| 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 ↗
On May 10, 2024, the impactful international academic journal, Science Immunology , a sub-journal of Science , published a research paper titled " Single-cell analysis of anti-BCMA CAR T cell therapy in patients with central nervous system autoimmunity". |
| 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 ↗
the Investigational New Drug (IND) application for its BCMA CAR-T (Equecabtagene Autoleucel) has been approved by the U.S. Food and Drug Administration (FDA) for use in U.S. clinical trials for generalised myasthenia gravis (gMG). |
| 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 ↗
On February 26, 2024, the impactful international academic journal, EMBO Molecular Medicine, published the clinical data of the fully human BCMA targeting autologous CAR-T cell injection (Equecabtagene Autoleucel, Eque-cel, CT103A) for the treatment of two refractory myasthenia gravis (MG) subjects . |
| 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 ↗
This study provides a potentially new therapeutic option for antibody-mediated autoimmune disorders. |
| 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 ↗
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. |
| 2023-12-12 | 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 ↗
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 ↗ |
| 2023-07-01 | 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 ↗
The updated data from the Phase 1/2 study with a longer duration of follow-up in more patients has showed durable and deepening efficacy, manageable safety and long-term in vivo persistence, indicating that Equecabtagene Autoleucel has the potential to be a breakthrough therapy for patients with R/R MM. |
| 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 ↗
Equecabtagene Autoleucel is the first CAR-T therapy in China that is self-developed with proprietary whole-process product development and the first BCMA-targeting CAR T-cell therapy in China with its NDA formally accepted by the NMPA . |
| 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 ↗
This NMPA acceptance, the world’s first IND application for CAR-T in NMOSD . |
All press releases naming this drug 40 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eque-cel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07510100 ↗ |
| Known as | Equecabtagene Autoleucel | “A Phase I/II Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) for the Treatment of Patients With...” NCT07510100 ↗ |
| Modality | Cell therapy | “Eque-cel consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector” NCT07510100 ↗ |