4 imported new drugs proposed breakthrough therapy 2 from Takeda Pharmaceuticals

TAK-935 (Soticlestat), a breakthrough therapy for two new drugs from the CDE website, is an selective CH24 H inhibitor developed jointly by Takeda Pharmaceuticals and Ovid Therapeutics.
the drug reduces the number and severity of seizures by suppressing cholesterol 24-hydroxyase (CH24 H) expressed in the brain.
the adaptations to be included in this breakthrough therapy are epilepsy Dravet syndrome and Lennox-Gastaut syndrome.
first clinical application from CDE's official Insight database, TAK-935 was first submitted in June 2018, first approved in October, and its first clinical trial in January 2019.
currently, the variety has two clinical developments in China, with the highest progress to Clinical Phase II.
TAK-620, a UL97 protein kinase inhibitor acquired by Takeda in its acquisition of Shire, has previously been recognized by the FDA as a breakthrough therapy.
to this breakthrough therapy is to treat a cytocytovirus (CMV) infection or disease that occurs after transplantation.
the development of the drug from CDE's official website has been tortuous: Maribavir was originally developed by ViroPharma, but abandoned in 2009 after a failed trial.
2013, Shire acquired the drug for $4.2 billion.
May 2018, Takeda acquired Shire, and ownership of the drug is vested in Takeda.
and platinum medicine "Bartoli monoanti" proposed breakthrough therapy Bartoli monoanti (HBM9161) is an all-human source monoclonal antibody targeting newborn Fc Subject (FcRn), the world's first innovative drug introduced from HanAll Biopharma, and platinum medicine has the right to develop, manufacture and commercialize in Greater China, including Hong Kong, Macau and Taiwan.
the adaptability of this proposed breakthrough therapy is: systemic severe muscle weakness.
From the CDE website Insight database, the drug has started 4 clinical projects in China, the developing indications include immunoploid reduction (Phase III clinical), severe muscle weakness (Phase II clinical), optic neurospinalitis (Phase I clinical) and diffuse goiter with hyperplatic hyperplus (approved clinical).
From insight database () AstraZenecom Nirsevimab's breakthrough therapy Nirsevimab is a next-generation respiratory syncytial virus (RSV) antibody drug for the prevention of respiratory syncytial virus RSV lower respiratory diseases that provide continuous protection during the 5-month RSV epidemic season with just one injection.
Nirsevimab is more than 50 times more in the RSV virus and has a half-life of 85-117 days, 4-6 times higher than the older generation of RSV antibody Palivizumab.
from CDE's official website in July 2020, its Phase 2b clinical results were published in NEJM.
results showed that for healthy premature children between the age of 29 and 35 weeks, the proportion of patients with lower respiratory tract infections caused by RSV in the Nirsevimab treatment group was 70.1% lower and the proportion of hospitalizations decreased by 78.4%.
, patients who needed ICU, auxiliary breathing, and oxygen supplementation were significantly reduced.
according to the Insight database, Nirsevimab was approved for clinical trials in China on October 30, 2020 and has not yet started a domestic clinical trial.