CASI Pharma gets NMPA’s nod to conduct confirmatory trial of ZEVALIN®
Category: #health  By Mateen Dalal  Date: 2019-02-20
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CASI Pharma gets NMPA’s nod to conduct confirmatory trial of ZEVALIN®
  • The firm previously secured greater China rights to ZEVALIN® from Spectrum and aims to launch ZEVALIN® in the country.
  • CASI Pharmaceuticals is currently addressing certain stipulations prescribed by the Center for Drug Evaluation (CDE) – a part of the NMPA

The U.S. based CASI Pharmaceuticals, Inc. has reportedly secured the approval from China’s National Medical Products Administration (NMPA) for its Clinical Trial Application (CTA) which allows it to conduct a confirmatory clinical trial, evaluating the safety and efficacy of ibritumomab tiuxetan injection (ZEVALIN®).

As per trusted sources, Ibritumomab tiuxetan (ZEVALIN®) is presently marketed in the U.S. by Spectrum Pharmaceuticals, Inc. For the record, ZEVALIN® is a U.S. FDA-approved drug indicated for the treatment of patients suffering from relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.

ZEVALIN® is augmented with a beta-emitting radioisotope and primarily builds on the combined therapeutic effects of a monoclonal antibody targeted against the CD20 antigen.

According to a press release issued by CASI Pharmaceuticals, the firm has previously secured greater China rights to ZEVALIN® from Spectrum Pharmaceuticals and aims to introduce the drug in the nation as soon as the confirmatory trial is concluded and marketing approval is secured from the NMPA.

The Executive Chairman of CASI Pharmaceuticals, Wei-Wu He, Ph.D., was reportedly quoted saying that the company is delighted to receive the approval from NMPA as now it can commence the confirmatory clinical trial for ZEVALIN® in China. The approval is a significant breakthrough for CASI Pharmaceuticals given the fact that it characterizes the regulatory strength of the firm’s team in working closely with the NMPA and the effective cross-border operations of the teams in China and the United States, Wei-Wu He further added.

Sources familiar with the development claim that CASI Pharmaceuticals is currently addressing certain stipulations laid down by the Center for Drug Evaluation (CDE), a part of the NMPA. The firm would be allowed to commence the ZEVALIN® clinical development program in China after satisfying those requirements.

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About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

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