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Pipeline

CASI’s business goal is to develop and accelerate the launch of pharmaceutical products and innovative therapeutics to address medical needs.
CASI March 2022 Pipeline

CNCT19 (CD19 CAR-T)

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, which is widely expressed during all phases of B-cell development. The CD19 antigen is a frequently used “target” in approved and investigational CAR-T cell therapies for hematological malignant diseases such as certain leukemias and lymphomas. The Phase 2 B-NHL and B-ALL registration studies of CNCT19 are both currently enrolling in China. CNCT19 received breakthrough Therapy Designation for B-ALL indication.
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)

Investigational Innovative Drug Candidate In-Licensed for Greater China Region

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). The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021.
BioInvent licenses anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals for Greater China region

CB-5339 (VCP/p97 inhibitor)

Investigational Innovative Drug Candidate In-Licensed for Greater China Region.
CB-5339 CTA application for the multiple myeloma indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation. Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, and is evaluating the molecule 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

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 ongoing 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.

About Us

CASI is a U.S. NASDAQ-listed biopharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China, through which substantially all of our operations are conducted.

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