Targeting IL-6 Baiji Shenzhou, the introduction of the Stoxi single resistance is intended to be included in the priority review

On January 11th, the Drug Review Center (CDE) of the State Drug Administration of China announced that the introduction of siltuximab (Sylvant) for injection in Baiji Shenzhou is to be included in the priority review for the treatment of adult patients with human immunodeficiency virus (HIV) negative and human herpes virus 8 (HHV-8) negative multi-center Castelman disease (multi-center Castleman disease).
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 lecytokine-6 (IL-6) may be a key driver of change.
is a monoclonal antibody that blocks the activity of elevated multifunction cytokine IL-6 detected in patients with multi-center Castleman disease.
first approved in the U.S. in April 2014, the product has been approved in more than 40 countries and territories worldwide for the treatment of HIV-negative, human herpes virus-8 (HHV-8) negative multi-center Castleman disease patients.
, it was also included in China's "first batch of clinically urgent need for new drugs abroad" list.
public information shows that Stoic monoantiton resistance was originally developed by Johnson and Johnson and then licensed to EUSA Pharma, and that Baiji Shenzhou received an exclusive development and commercial interest in the drug in Greater China in January 2020.
, the drug has been approved by China's State Drug Administration (NMPA) fast-track approval, in line with the clinical urgent need for new drugs abroad review and approval procedures.
In China, Stoic monoantin has completed an international multi-center Phase 2 clinical trial aimed at combining the best support therapy with the effectiveness of single-use best support therapy in subjects with random double-blind comparative multi-center Castleman disease.
the main indicators of the study were the continuous remission of tumors and symptoms (complete relief of the "CR" plus partial remission of the "PR"), and the entry of 16 persons in China and 79 persons in the international group.
, a study evaluating the long-term safety of Stoxi monoantial resistance among Castleman's patients is under way in China.
this is an international multi-centre single-arm phase 2 trial, which has now completed the recruitment of subjects.
, it is understood that the main endpoint of the study is the number of patients with adverse events as a safety indicator, evaluation time of up to 5 years.
hope that the product will be approved in China at an early time, bringing new treatment options to more Castleman patients.