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Overview

CASI Pharmaceuticals, Inc. is a U.S. NASDAQ-listed biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products. CASI has built a portfolio that includes approved and investigational assets. We have offices in Rockville, Maryland, and a wholly-owned subsidiary in Beijing, China, through which our China operations are conducted.

CASI is dedicated to the development and delivery of innovative therapeutics and high-quality pharmaceuticals to patients worldwide while targeting the China market. We are focused on acquiring, licensing, developing, and commercializing products that address areas of unmet medical need. We intend to execute our plan to become the leading platform to launch medicines in the Greater China market leveraging our China-based regulatory and commercial competencies and our global drug development expertise.

We have a strong and growing pipeline of commercially available and clinical-stage drug candidates and continue to (i) acquire additional approved and clinical-stage drug candidates through in-license and acquisitions, and (ii) explore drug candidates in preclinical development.

In August 2019, we launched our first commercial product, EVOMELA® (Melphalan for Injection), In China. In China, EVOMELA is approved for use as a conditioning treatment prior to stem cell transplantation and as a palliative treatment for patients with multiple myeloma. The other core hematology/oncology assets in our pipeline include (i) CNCT19 an autologous CD19 CAR-T investigative product (CNCT19) being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia (“B-ALL”) and B-cell non-Hodgkin lymphoma (“B-NHL”); (ii) BI-1206 an antibody which has a novel mode-of-action, blocking the inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity in both hematological malignancies and solid tumors; (iii) CB-5339 a novel oral second-generation, small molecule VCP/p97 inhibitor; (iv) CID-103 a full human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy & safety profile compared to other anti-CD38 monoclonal antibodies.

Other assets in our pipeline for which we have exclusive rights in China are Octreotide Long Acting Injectable (“LAI”), for which we plan to begin the China registration study in 2021, and a novel formulation of Thiotepa, for which our partner plans to begin the China registration study in 2021. Thiotepa is used as a conditioning treatment for certain allogeneic haemopoietic stem cell transplants. Subject to regulatory and marketing approvals, we intend to advance and commercialize these established products in China.

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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