License Arrangements

9 Months Ended

Sep. 30, 2017

Research, Development, and Computer Software Disclosure [Text Block]

2.	License Arrangements

The Company has certain product rights and perpetual exclusive licenses from Spectrum Pharmaceuticals, Inc. and certain of its affiliates (together referred to as “Spectrum”) to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”):

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EVOMELA^® (melphalan) for Injection (“Evomela”);

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MARQIBO^® (vinCRIStine sulfate LIPOSOME injection) (“Marqibo”); and

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ZEVALIN^® (ibritumomab tiuxetan) (“Zevalin”).

CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed.

The Company is in various stages of the regulatory and development process to obtain marketing approval for EVOMELA^®, MARQIBO^®, and ZEVALIN^® in its territorial region, with ZEVALIN^® commercially available in Hong Kong. In January 2016, the China Food and Drug Administration (CFDA) accepted for review the Company’s import drug registration application for MARQIBO^® and currently is in the quality testing phase of the regulatory process. On March 10, 2016, Spectrum received notification from the U.S. Food and Drug Administration (FDA) of the grant of approval of its New Drug Application (NDA) for EVOMELA^® primarily for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. In December 2016, the CFDA accepted for review the Company’s import drug registration application for EVOMELA^® and in 2017 has granted priority review of the import drug registration clinical trial application (CTA), which currently is in the quality testing phase of the regulatory process. The CFDA filing and review of CASI’s ZEVALIN^® import drug CTA is in process. The ZEVALIN^® antibody kit and the radioactive Yttrium-90 component of the CTA require separate submissions to the CFDA, of which the first part is currently under review and the latter part is in the submission process.