CASI’s business goal is to develop and accelerate the launch of pharmaceutical products and innovative therapeutics to address medical needs.
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.
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.
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.
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.
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.
For the most up-to-date safety information about these drugs, please refer to our partner’s websites:
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.
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.
CASI’s assets include a small portfolio of FDA-approved and FDA-pending ANDAs for generic products.