CASI Pharmeceuticals

Press Release

CASI Pharmaceuticals Announces Appointment Of President To Its China Operations To Lead Commercialization

ROCKVILLE, Md., Oct. 2, 2018 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces the appointment of Larry Zhang to the position of President of CASI (Beijing) Pharmaceuticals Co., Ltd., the China operating subsidiary of CASI Pharmaceuticals, Inc. headquartered in Rockville, Maryland.

Mr. Zhang possesses over 20 years of executive experience in commercial operations, regulatory affairs, sales and marketing, and business development within the healthcare and biopharmaceutical industries in the U.S., Asia Pacific and China. Prior to joining CASI’s Beijing office, Mr. Zhang was Vice President, Head of Public Affairs and Corporate Responsibility at Novartis Group (China) focusing on the public affairs and public relations strategy including initiating Novartis’ China policy focusing on China FDA (CFDA) new drug approval reform, IP protection, generic quality consistency evaluation and new regulations on biosimilars. In this role, he regularly liaised with key central and provisional government authorities to advance various policy initiatives.

Prior to joining Novartis Group (China), he served as Chief Executive Officer of Sandoz (China) Pharmaceutical Co. Ltd, a Novartis Company, where he oversaw the successful launch of six new products. Mr. Zhang has also held executive leadership roles within Bayer Healthcare and Baxter International Corporation in the U.S. and Asia Pacific. He holds bachelor and master’s degrees in nuclear physics from the University of Science & Technology of China, and an M.B.A. in marketing/finance from the University of California at Los Angeles (UCLA). He also received training in the political science doctoral program from the University of Utah.

Wei-Wu He, Ph.D., Executive Chairman of CASI Pharmaceuticals, commented, “We are excited to welcome Larry to our management team. His cross-functional executive expertise, particularly in navigating CFDA reforms and governmental affairs within the generic pharmaceuticals sector, will be invaluable to CASI’s advancement and growth as we continue to expand and advance our pipeline.”

About CASI Pharmaceuticals, Inc.

CASI Pharmaceuticals (NASDAQ: CASI) is a U.S.-based biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., Chinaand throughout the world. CASI’s product pipeline features three U.S. Food and Drug Administration (FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights. These are currently in various stages in the regulatory process for market approval in China. The Company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs that are pending FDA approval. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. 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: risks relating to interests of our largest stockholders that differ from our other stockholders; the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our recently acquired portfolio of abbreviated new drug applications (ANDAs); 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 China Food and Drug Administration 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 our product candidates; risks associated with any early-stage products under development; risk 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.

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