FDA grants Corchi bio-whole BCMA CAR-T cell (CT053) "orphan drug" qualification
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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recently, cozie bio
pharmaceutical(http://(Shanghai) limitedcompany(http://(CARsgen Therapeutics) announced that the U.SFoodmedicine s(http://Regulatory Authority (US
FDA(http://) granted itsproduct son(http://for the treatment of multiple myeloma CAR-T cell (CT053) "orphan drug" qualification The FDA's accreditation of 'orphan medicine' is an important regulatory milestone in the development and commercialization of CT053, which is currently undergoing registered clinical research in China, including Chaoyang Hospital in Beijing and First Hospital affiliated with Suzhou University, said Dr Li Zonghai, Chairman, CEO and CSO CT053 was also licensed for clinical trial trials in the United States and Canada in June and July this year, respectively, http:// exploratory Phase I clinical research data show that CT053 has very excellent clinical efficacy and good safety, and 19 of the 24 patients with recurrent and difficult to treat multiple myeloma reached full remission (total remission rate of 79.2%) and did not have stage 3 and above cytokine release syndrome Orphan drugs are drug (http:// and biological products used to treat, diagnose, or prevent rare diseases/diseases that affect less than 200,000 people, and are granted by the US FDA Orphan Drug Product Development Office
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