Founded in 2017, IASO Bio is a leading biopharmaceutical company specializing in the discovery, development, manufacturing, and commercialization of cutting-edge cell therapies and biologics. Initially focused on treatments for blood cancers, the company has strategically expanded into autoimmune diseases.
IASO Bio boasts a robust drug development platform, encompassing early discovery to clinical trials, regulatory approval, and commercialization. The company is advancing a diverse pipeline of over 10 innovative products. Notably, Equecabtagene Autoleucel (Fucaso®), the world’s first fully human CAR-T therapy developed by IASO Bio was approved by Chinese National Medical Products Administration (NMPA) in June 2023 for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent. relapsed/refractory multiple myeloma (R/RMM) in patients at the fourth line and beyond. This product is also in Phase III clinical trials for second and third-line multiple myeloma (MM) and has received Investigational New Drug (IND) approvals in both China and US for autoimmune diseases. Meanwhile, the dual-target (CD19/CD22) product, CT120, for lymphoma is entering Phase II clinical trials. Additionally, IASO118, another product targeting GPRC5D for the treatment of R/R MM, has received IND approval in China.
In addition to CAR-T therapies, IASO Bio is advancing IASO-782, a fully human anti-CD19 monoclonal antibody. This product has secured IND approvals in China and USA for several autoimmune diseases, with plans to explore additional autoimmune indications.
IASO Bio has established multiple global collaborations and licensing agreements with leading cell therapy companies, such as Sana Therapeutics, CabalettaBio, and Umoja Biopharma, underscoring its superior technology platform and commitment to next-generation cell therapies.
With a strong management team, a robust pipeline, high-standard manufacturing and advanced clinical development capabilities, the company is well-positioned to drive innovation. It remains committed to accelerating the development of transformative therapies that address unmet medical needs for patients worldwide.
Equecabtagene Autoleucel receives IND approval from FDA for Non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis(LN)
IASO-782 receives IND approval from NMPA for Systemic Lupus Erythematosus
Equecabtagene Autoleucel receives IND from FDA for Multiple Sclerosis
IASO Bio obtains global commercial rights and the intellectual property license for FUCASO® ,Innovent becomes a strategic shareholder
RD118 Receives IND Approval from NMPA
FAD'S IND approval for Equecabtagene Autoleucel for Generalized Myasthenia Gravis
NMPA's IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma
IND for IASO-782 Injection was aprroved both by FAD and NMPA
NDA for Equecabtagene Autoleucel was approved by NMPA
CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA
Closed Nearly $75 Million in Series C1 Funding
IND for CT103A was approved by the U.S. FDA for use in U.S. clinical trials for relapsed/refractory multiple myeloma (R/R MM)
Umoja Biopharma and IASO Biotherapeutics Announce Research Collaboration to Bring Off-the-Shelf Therapies to Patients with Hematological Malignancies
Cabaletta Bio and IASO Biotherapeutics Announce Exclusive Worldwide License Agreement for Clinically Validated CD19 Binder
IND application for CT103A new extended indication of NMOSD was approved by CDE
NMPA Acceptance of the NDA for Equecabtagene Autoleucel（CT103A） for the Treatment of R/R MM
Equecabtagene Autoleucel for Treatment of NMOSD Receives IND Application Acceptance by NMPA
IASO Bio’s Nanjing Manufacturing Facility Granted the Drug Manufacturing License for CAR-T Cell Therapy Products
CT120 granted Orphan Drug Designation by the U.S. FDA
First patient enrolled for the phase I/II trial of CT120
Closed $108 Million Series C Funding
China IND approval for CT120
Oral presentation at 2021 European Hematology Association (EHA) Congress
Clinical trial results of CT103A commented in American Society of Hematology’s medical journal Blood
Breakthrough Therapy Designation granted to CT103A by the CDE
Pre-IND application for CT120
Commercial facilities completed and put into operation
Medical research commencing for fully-human nanobody RD125
First patient enrolled for the Phase II trial of CT103A
Fully-human dual-targeted CT120 kicking off IIT research
Starting construction of International R&D Center and manufacturing base
First patient enrolled for the Phase 1b trial of CT103A
Commencement of Shanghai R&D platform
Hillhouse Capital Group became the exclusive investor in the company's Series B fundraising with an investment of US$60 million.
Receiving Phase Ib/II approval for the CT103A IND application
Submitting the IND application in China for its first CAR-T product, CT103A.
Completing construction of its proprietary human antibody library
Completing Series A fundraising with proceeds of RMB 60 million
Partnering with Innovent Biologics in the development of autogenous CAR-T product based on BCMA targets
Setting up a GMP platform for research, development and intermediate testing of plasmids, viruses and cell
IASO Biotherapeutics was established
