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On September 14, CDE announced its plan to include Suzhou Emezin Pharmaceuticals Class 4 generic drug "Magstal Capsules" in its priority review review.
the drug is a rare disease treatment for patients with type C Neimanpike in adults and children.
McGrath is a glucose ceramide synthase inhibitor first developed by Xi'an Jansen's Swiss company Acoteron for the treatment of Type C Nemanpike disease.
the product was certified as an EMA orphan drug in 2006 and approved in Europe in 2009 under the name ZAVESCA, followed by approval in more than 30 countries, the only drug approved worldwide for Type C Nemanpike disease.
2015, Acotlon submitted a domestic application for the listing of McGregor capsules, and in November 2016, it was approved by the NMPA for domestic listing under the name "Zevico".
the 2019 health care negotiations, seven rare disease medications, including McGregor, were successfully entered into Medicare B, with a 10.4% reduction of 128 yuan (100mg/tablet) from January 1, 2020 to December 31, 2021.
type C Neimanpike disease is a rare autosomal recessive genetic lysosome storing disorder, with neurological symptoms as the main manifestation.
the disease is mostly in late innocenia (2 to 6 years old) and juvenile (6 to 15 years old) onset, symptoms deteriorate rapidly, seriously affecting the growth and development of children, so that more patients die in 10-25 years of age.
the generic drug will be included in the priority review review, or will accelerate the generic drug market, to provide patients with new options.
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