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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 December 2020 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 China NMPA has approved the clinical trial applications for CNCT19 in Phase 1 studies in B-NHL and 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

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.

BioInvent licenses anti-FcγRllB antibody BI-1206 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 file an IMPD/CTA for CID-103 in the first half of 2020, with Phase 1 trials expected to start in the United Kingdom during the second half of 2020.
CASI Pharmaceuticals In-Licenses Exclusive Worldwide Rights to Novel Anti-CD38 Monoclonal Antibody Program From Black Belt Therapeutics.

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

ZEVALIN® (ibritumomab tiuxetan)

ZEVALIN is a CD20-directed radiotherapeutic antibody indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). We intend to advance the development, import drug registration, and market approval of ZEVALIN in China and currently is in the planning/execution stage for the registration study.
CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Confirmatory Clinical Trial For ZEVALIN®

MARQIBO® (vinCRIStine sulfate LIPOSOME injection)

MARQIBO is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate, a microtubule inhibitor, approved by the FDA for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. In March 2019, the Company received NMPA’s approval of the Company’s Clinical Trial Application (CTA) to allow for a trial to evaluate its efficacy and safety.
CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Registration Trial For MARQIBO®
For the most up-to-date safety information about these drugs, please refer to our partner’s websites:
http://www.evomela.com
http://www.zevalin.com
http://www.marqibo.com

Octreotide Long Acting Injectable (LAI) Microsphere

Octreotide LAI formulations are considered a standard of care for the treatment of acromegaly and for the control of symptoms associated with certain neuroendocrine tumors. In October 2019, the Company acquired exclusive China development and distribution rights for Octreotide LAI from Pharmathen Global BV. Octreotide LAI has been approved in various European countries. CASI intends to advance the development, import drug registration, and market approval of this product in China. The Company expects the clinical development program to begin during 2020.

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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