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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 September 2019 Pipeline

Please see this page for CASI’s portfolio of U.S. FDA approved and pending ANDAs for generic products.

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. CID-103 is currently at the IND/IMPD submission stage of development. Phase 1 trails are expected to start in late 2019 or early 2020. CASI Pharmaceuticals In-Licenses Exclusive Worldwide Rights to Novel Anti-CD38 Monoclonal Antibody Program From Black Belt Therapeutics.

CNCT19 targets CD19, 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. CASI Pharmaceuticals Acquires Worldwide Rights To Commercialize anti-CD19 T-cell Therapy

EVOMELA® (melphalan hydrochloride for injection), 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. CASI Pharmaceuticals Announces China Market Approval Of Melphalan Hydrochloride For Injection

MARQIBO® (vinCRIStine sulfate LIPOSOME injection), indicated for the treatment of advanced Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL), was approved by the NMPA for registration confirmatory trial in China. CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Registration Trial For MARQIBO®

ZEVALIN® (ibritumomab tiuxetan), indicated for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL), was approved by the NMPA to conduct a registration confirmatory trial in China. CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Confirmatory Clinical Trial For ZEVALIN®

For the most up-to-date safety information about these drugs, please refer to our partner’s websites:

http://www.evomela.com

http://www.marqibo.com

http://www.zevalin.com

ENMD-2076 is our proprietary orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. ENMD-2076 is not being pursued as a single agent, and feasibility is being assessed as part of a combination clinical strategy.

In addition, to address the high demand by patients in China for high-quality, affordable pharmaceuticals, CASI has acquired a portfolio of U.S. FDA approved and pending ANDAs for generic products. Please see http://www.casipharmaceuticals.com/product-pipeline/us-fda-approved-andas/.

CASI will continue to aggressively expand its portfolio through in-licensing and acquisition.

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, 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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