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Recent popular reports from Yimaike ★ Nanjing · Big coffee gathered in May2021 nucleic acid drug development forum announced schedule ★ May Nanjing2021 nucleic acid drug development forum is about to open April 29, 2021 / Yimaike news eMedClub News/--Recently, Enzyvant announced that it has resubmitted a biologics license application (BLA) for RVT-802 to the US FDA for the treatment of pediatric congenital athymia (pediatric congenital athymia).
Pediatric congenital athymia is a fatal disease caused by genetic mutations.
It is characterized by loss of thymus at birth, which causes immunodeficiency, immune disorders and susceptibility to infection.
Most patients usually die of infection at the age of 2-3 Or autoimmune problems, there is currently no FDA-approved treatment.
RVT-802 is based on the research results of Professor Mary Louise Markert of Duke University.
RVT-802 is a one-time regenerative therapy for the treatment of congenital athymia in children.
The process of "T cells start from bone marrow stem cells and then transfer to the thymus to fully develop" occurs in the immune system of China.
RVT-802 is an allogeneic regenerative therapy, which is derived from infant thymus tissue and is injected into the patient’s quadriceps after processing and culture.
The patient's bone marrow stem cells migrate to the implanted tissue product site, where they differentiate into primitive, immunocompetent T cells.
After regaining the ability to produce T cells, the function of the immune system is restored.
Enzyvant is one of the Vant companies founded by Roivant Sciences.
In 2020, Japanese pharmaceutical company Sumitomo Dainippon Pharma announced that it has completed the acquisition of five Vant companies including Enzyvant.Recommended reading: Another pharmaceutical giant is deploying gene therapy.
Japan's Sumitomo Pharmaceuticals completed the acquisition of 3 billion US dollars at the end of the year.
Yimai Meng broke the news.
In fact, as early as 2019, Enzyvant has submitted a BLA application for RVT-802 to the US FDA.
The BLA application was given a CRL (Complete Reply Letter), pointing out a number of regulatory requirements related to CMC (Chemistry, Production and Control).
It is not the first time that CMC has affected the progress of drug development and marketing.
The most interesting thing is that last year’s BMS/Bluebird Bio’s BCMA CAR-T candidate product bb2121 was rejected by the FDA for a biological product license (BLA) because of concerns about the CMC part; it was subsequently approved by the US FDA in 2021.
.
Recommended reading: FDA temporarily rejected the BCMA CAR-T listing application of BMS and Bluebird Bio, CMC once again sounded the alarm! Yi Mai Meng broke the news! The first BCMA CAR-T was approved for listing today! Yimai Meng broke the news that the 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".
Pediatric congenital athymia is a fatal disease caused by genetic mutations.
It is characterized by loss of thymus at birth, which causes immunodeficiency, immune disorders and susceptibility to infection.
Most patients usually die of infection at the age of 2-3 Or autoimmune problems, there is currently no FDA-approved treatment.
RVT-802 is based on the research results of Professor Mary Louise Markert of Duke University.
RVT-802 is a one-time regenerative therapy for the treatment of congenital athymia in children.
The process of "T cells start from bone marrow stem cells and then transfer to the thymus to fully develop" occurs in the immune system of China.
RVT-802 is an allogeneic regenerative therapy, which is derived from infant thymus tissue and is injected into the patient’s quadriceps after processing and culture.
The patient's bone marrow stem cells migrate to the implanted tissue product site, where they differentiate into primitive, immunocompetent T cells.
After regaining the ability to produce T cells, the function of the immune system is restored.
Enzyvant is one of the Vant companies founded by Roivant Sciences.
In 2020, Japanese pharmaceutical company Sumitomo Dainippon Pharma announced that it has completed the acquisition of five Vant companies including Enzyvant.Recommended reading: Another pharmaceutical giant is deploying gene therapy.
Japan's Sumitomo Pharmaceuticals completed the acquisition of 3 billion US dollars at the end of the year.
Yimai Meng broke the news.
In fact, as early as 2019, Enzyvant has submitted a BLA application for RVT-802 to the US FDA.
The BLA application was given a CRL (Complete Reply Letter), pointing out a number of regulatory requirements related to CMC (Chemistry, Production and Control).
It is not the first time that CMC has affected the progress of drug development and marketing.
The most interesting thing is that last year’s BMS/Bluebird Bio’s BCMA CAR-T candidate product bb2121 was rejected by the FDA for a biological product license (BLA) because of concerns about the CMC part; it was subsequently approved by the US FDA in 2021.
.
Recommended reading: FDA temporarily rejected the BCMA CAR-T listing application of BMS and Bluebird Bio, CMC once again sounded the alarm! Yi Mai Meng broke the news! The first BCMA CAR-T was approved for listing today! Yimai Meng broke the news that the 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".
