Acrotech License Arrangements

9 Months Ended

Sep. 30, 2020

Acrotech License Arrangements

Acrotech License Arrangements

18.          Acrotech License Arrangements

The Company has certain product rights and perpetual exclusive licenses from Acrotech Biopharma L.L.C. (“Acrotech”) 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”):

● EVOMELA^® (Melphalan Hydrochloride For Injection)

● ZEVALIN^® (Ibritumomab Tiuxetan); and

● MARQIBO^® (Vincristine Sulfate Liposome Injection)

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.

On December 3, 2018 the Company received NMPA’s approval for importation, marketing and sales in China for EVOMELA. The Company has in place an experienced commercial team with a successful track record to execute the commercial sales of EVOMELA that launched in August 2019. The Company has initiated an NMPA required post-marketing study in 2020.

On February 12, 2019, the Company received NMPA’s approval of the Company’s clinical trial application (CTA) to conduct a registration trial to evaluate the efficacy and safety of ZEVALIN. The Company expects to initiate a ZEVALIN registration study in China in 2021.