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CASI’s business goal is to develop and accelerate the launch of pharmaceutical products and innovative therapeutics to address medical needs.
Assets Indications
Pre-clinical IND/IMPD Phase I Phase II Phase III NDA/ANDA
(Autologous Anti-CD19 T-cell therapy)
Pediatric B-ALL
(Anti-FcγRIIB antibody)
Solid Tumors
(Anti-CD 38 mAb)
Multiple Myeloma
Multiple Myeloma

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell hematological malignancies. It has obtained three IND approval from the National Medical Products Administration (NMPA), for the treatment of adult relapsed and refractory acute lymphoblastic leukemia, relapsed and refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent B-cell acute lymphoblastic leukemia. 


CASI Pharmaceuticals Announces CNCT19 (CD19 CAR-T) Granted Orphan Drug Designation By The U.S. FDA

CASI Pharmaceuticals Announces CNCT19 (CD19 CAR-T) Receives China Breakthrough Therapy Designation

CASI Pharmaceuticals Announces China NMPA Approval Of CNCT19 (CD19 CAR-T) Clinical Trial Applications

CASI Pharmaceuticals Acquires Worldwide Rights To Commercialize anti-CD19 T-cell Therapy

BI-1206 (Anti-FcγRIIB antibody)

BI-206 is a first-in-class, fully human monoclonal antibody (“mAb”) that targets FcγRIIB. 

BI-1206 has a novel mode-of-action, blocking the single inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity in both liquid and solid tumors. 

BI-1206 is being investigated by our partner BioInvent in a Phase I/II trial, in combination with anti-PD1 therapy Keytruda® (pembrolizumab), in solid tumors, and in a Phase I/IIa trial in combination with MabThera® (rituximab) for the treatment of non-Hodgkin lymphoma (NHL).


BioInvent licenses anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals for Greater China region

CID-103 (Anti-CD38 mAb)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID 103, in patients with previously treated, relapsed or refractory multiple myeloma is  closed to further accrual in France and the UK.


CASI Pharmaceuticals Announces Dosing Of First Patient Of CID-103 In Phase 1 Clinical Trial For Relapsed Or Refractory Multiple Myeloma.

CASI Pharmaceuticals In-Licenses Exclusive Worldwide Rights to Novel Anti-CD38 Monoclonal Antibody Program From Black Belt Therapeutics.


CASI acquired exclusive China rights for the development and distribution of a novel formulation of Thiotepa, a chemotherapeutic agent, which has multiple indications including used as a conditioning treatment prior to a hematopoietic stem cell transplantation. 
Thiotepa has a long history of established use in the hematology/oncology setting.

Thiotepa is in the process of China market approval.

CB-5339 (VCP/p97 inhibitor)

VCP/p97 plays a critical role in protein homeostasis processes such as endoplasmic reticulum associated degradation (ERAD) and chromatin-associated degradation (CAD), as well as the DNA damage response (DDR). These key cellular stress pathways are known to represent sensitivities critical to cancer cell survival. 

First-in-class CB-5339 is an oral second-generation, small molecule VCP/p97 inhibitor. It is being evaluated by Cleave Therapeutics in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). 


Cleave Therapeutics Licenses First-in-Class VCP/P97 Inhibitor CB-5339 To CASI Pharmaceuticals for Greater China Region