The application for the listing of IL-6 inhibitors introduced by Baiji Shenzhou was accepted by CDE

According to the latest announcement from the Drug Review Center (CDE) of the State Drug Administration of China, EUSA Pharma and Baiji Shenzhou jointly submitted two applications for the listing of siltuximab, an injection of IL-6 inhibitors, which were accepted on January 20.
It is worth mentioning that the drug was included in the proposed priority review by CDE just a week ago for adult patients with "multi-center Castleman disease (multi-center Castleman disease) for the treatment of human immunodeficiency virus (HIV)-negative and human herpes virus 8 (HHV-8) negative".
Screenshot Source: CDE's official website multi-center Castleman disease is a rare, life-threatening disease of depleted lymphatic tissue that produces abnormal growth of immune cells and has many similarities with lymphoma in symptoms and histological characteristics.
patients can have different symptoms: some are individual lymph node abnormalities, accompanied by mild flu-like symptoms;
study suggests that changes in lecytokine-6 (IL-6) may be a key driver of the disease.
is an IL-6 inhibitor originally developed by Johnson and Johnson and later licensed to EUSA Pharma.
2020, Baiji Shenzhou reached a partnership with EUSA Pharma to develop and commercialize two drugs in Greater China, including Stoic monoanti.
public information, stoic monoantin can be used to block the activity of elevated multifunction cytokine IL-6 detected in patients with multi-center Castleman disease.
first approved in the U.S. in 2014, the product has been approved in more than 40 countries and regions around the world for the treatment of HIV-negative, human herpes virus-8-negative multi-center Castleman disease patients.
in China, Stoic monoantin has been included in the list of "First Clinically Urgent Need for New Drugs Abroad" for rare diseases.
Clinically urgent need for new drugs abroad mainly refers to in recent years in Europe, the United States and Japan have been listed but not yet listed in China, for the treatment of rare diseases, serious life-threatening or seriously affect the quality of life of diseases, and there is no effective treatment or has a clear clinical advantage of new drugs.
for these drugs, the NMPA will expedite the review and approval in accordance with the priority review and approval procedures if the applicant studies that there is no difference in ethra being able to apply for listing in China.
this time, the listing application of Stoic monoantitons has been accepted by CDE, which means that Stoic monoantitons are expected to be approved for listing in China soon, giving patients with Castleman disease treatment options.
it is worth mentioning that in 2020, the application for the listing of another drug, dinutuximab beta, introduced from EUSA Pharma, together with Stuxima, has been accepted by CDE and is included in the priority review.
Dittoxi monoantigen is a monoclonal antibody targeting GD2, and Baiji Shenzhou has exclusive development and commercial rights to the drug in Chinese mainland.
The proposed adaptation to the drug's declaration in China is: suitable for the treatment of≥ patients with high-risk neuroblastoma at 12 months of age, as well as recurring or resuscious neuroblastoma with or without residual lesions.
the introduction of biopharmaceutical enterprises is one of the important ways to expand the pipeline, in the past few years, Baiji Shenzhou has also introduced a series of products in research.
according to public information, in 2020, in addition to EUSA Pharma, Baiji Shenzhou and Assymbly Biosciences, Baatee Bio, Leap Therapeutics, etc. have also reached a authorized cooperation, involving products related to the treatment of chronic hepatitis B infection in the research of innovative drugs, beva bead monobial drugs, humanized monoclonal antibody DKN-01 and so on.
the present, these imported products are making significant progress.
to the early approval of these drugs, bringing new treatment options to patients.
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