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Biopharmaceuticals Oncology Licensing Distribution

 News Release - November 7, 2019

CASI Pharmaceuticals Enters Exclusive China Distribution License Agreement for Octreotide Long Acting Injectable (LAI) Microsphere for Neuroendocrine Cancers and Acromegaly

ROCKVILLE, Md. and BEIJING, Nov. 7, 2019 -- (Healthcare Sales & Marketing Network) -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces an exclusive distribution agreement with Pharmathen Global BV for the development and distribution of octreotide long acting injectable (LAI) microsphere in China. 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. Pharmathen has received regulatory approvals in various European countries. CASI will be responsible for the development, import drug registration and product approval in China and has a long-term exclusive distribution right for the China market after product launch.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer stated, "Octreotide LAI is an asset that we feel enhances and adds value to our growing portfolio of oncology products. Based on historical data, we are confident in the sales projections for octreotide LAI in China as this market has experienced continued growth over the last several years. We believe octreotide LAI will add significant value to patients with neuroendocrine tumors in China which are likely underreported and potentially mistreated. With improvements in diagnostic testing and clinical detection, the number of neuroendocrine tumors diagnosed and treated in China is expected to increase."

About Octreotide

Octreotide is a synthetic peptide which potently mimics the inhibitory activity of the natural hormone somatostatin. Octreotide LAI microsphere is a slow release formulation of octreotide which reduces the need for frequent physician visits and administration, while maintaining the clinical and pharmacological characteristics of the immediate-release formulation of octreotide.

US prescribing and indication details for Octreotide and Octreotide LAI can be found at https://www.fda.gov/

About CASI Pharmaceuticals

CASI is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets. The Company recently launched its first commercial product EVOMELAŽ (Melphalan for Injection) in China and has a pipeline that includes (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed for the treatment of B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of CD38 positive hematological malignancies; (iii) exclusive greater China rights to two U.S. Food and Drug Administration (FDA)-approved hematology oncology drugs, consisting of ZEVALINŽ (Ibritumomab Tiuxetan) and MARQIBOŽ (Vincristine Sulfate Liposome Injection); (iv) China rights to an octreotide long acting injectable (LAI) octreotide microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly. In addition, the Company also maintains a small portfolio of FDA-approved ANDAs and are currently assessing the development plan in China for a select subset. More information on CASI is available at www.casipharmaceuticals.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the difficulty of executing our business strategy in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, NMPA, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with CID-103, CNCT19, and our product candidates; risks associated with CID-103, CNCT19, and our other early-stage products under development; risks that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; and our dependence on third parties. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

EVOMELAŽ, ZevalinŽ and MarqiboŽ are proprietary to Acrotech Biopharma LLC and its affiliates.


Source: CASI Pharmaceuticals

Issuer of this News Release is solely responsible for its content.
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