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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 April 2021 Pipeline

EVOMELA® (melphalan hydrochloride for injection)

Evomela used as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma, was approved by China National Medical Products Administration (NMPA) for marketing in China. In August 2019, CASI launched EVOMELA in China as its first commercial product.

CASI Pharmaceuticals Announces Launch of EVOMELA® (melphalan for injection) in China
CASI Pharmaceuticals Announces China Market Approval of Melphalan Hydrochloride For Injection

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. B-NHL Phase 2 registration trial is currently enrolling; B-ALL Phase 2 registration trial expected to be initiated in Q1 2021. Breakthrough designation received for B-ALL.
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). CASI intends to advance development plans in China, starting with regulatory submission with China’s NMPA.
CASI Pharmaceuticals Partner, BioInvent, Presents Phase I/IIA Data That Suggests BI-1206 Restores Activity Of Rituximab In Relapsed Non-Hodgkin’s Lymphoma Patients
BioInvent licenses anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals for Greater China region

CB-5339 (VCP/p97 inhibitor)

CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, is being evaluated in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), CB-5339 is in a Phase 1 clinical trial of patients with solid tumors and lymphomas.

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 novel investigational anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma. Preclinical data demonstrate CID-103 to have enhanced activity against a broad array of malignancies which express CD38, and potentially better safety and best in class when compared to other CD38 monoclonal antibodies. CASI expects to initiate Phase 1 trials in EU during Q1 2021.

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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