Bollinger Ingerham Ethyl Nidanibu softgel (Vegat ®) accepted by China Drug Administration

recently, Bollinger Ingham announced that the ChinaMedicines(http://Regulatory Authority has formally accepted the application for the registration of the ethyl sulfonate Nidanibu softgel (Vegat ®) for the treatment of sexualfied interstitial pulmonary disease (PF-ILD) indicationsThe successful submission of these two new indications is based primarily on the positive results of the inBUILD ® and SENSCIS ® thedata of the two Phase III clinicaltrials(http://INBUILD ® results showed that Nidanib slowed the annual decline in the force lung capacity of the study population by 57%, and also showed that Nidanib had good effectiveness and safety for all types of patients with sexualficofied interstitial pulmonary disease (PF-ILD)SENSCIS® results have shown that Nidanibu can slow down the annual decline in the amount of force lung capacity in patients with systemic sclerosis-related interstitial pulmonary disease (SSc-ILD), and delay the progression of sSSc-ILD patients
In a phase III clinical study of blind, placebo-controlled, parallel groupings, the effectiveness, safety and tolerance of Nidanibu (150 mg, 2 times per day) in patients with PF-ILD were assessed over a 52-week period in 153 research centers in 15 countriesAt the main point of the study, Nidanibu slowed the annual decline in lung function in the study population by 57%This shows that Nidanib has good effectiveness and safety for patients with a variety of performing fibrosis interstitial pulmonary disease, except isotrotic pulmonary fibrosis (IPF), and provides a new treatment for PF-ILD patientsNindanib Phase 3 Clinical Study (SENSCIS) for Systemic Sclerosis-Related Interscotic Lung Disease (SSc-ILD) is a multicenter randomized, double-blind, placebo-controlled trial covering 32 countries and regions, involving 576 patients, with 9 research centers in China participatingThe study was designed to explore the effectiveness and safety of Nidanibu's treatment of SSc-ILD patients for 52 weeks, with an annual decline in force lung capacity (FVC) during 52 weeksStudies have shown that nidanibu can slow down the annual decline in force lung capacity (FVC) in Patients with SSc-ILD, slowing lung function decline and disease progression in SSc-ILD patients