Shandong Sihuan Pharmaceutical Co.,Ltd.
The listing application is approved by CFDA Boehringer Ingelheim blockbuster drug diethylsulfonate nidanibu soft capsule
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial lung disease. The lesions are confined to the lungs and are more common in the elderly. The 3 year mortality rate of IPF is 50%, which is more terrible than cancer. In pirfenidone before the listing, IPF no effective treatment drugs (http://www.chemdrug.com/), can be used for lung transplantation and conservative therapy.
Recently, Blyngju G John blockbuster drug (http://www.chemdrug.com/) application for listing nidanibu ethanesulfonic acid soft capsule (JXHS1700020, JXHS1700021) CFDA (http://www.chemdrug.com/article/11/) approved for the treatment of idiopathic pulmonary fibrosis (IPF). This is Blyngju G John's third new drugs listed in China after 2017, following the release of the French drugs.
Nidanibu ethanesulfonic acid soft capsule for listed CDE in April 17, 2017 to June 6, 2017 was accepted, CDE included in the priority review, as of today approved only lasted 5 months.
Ofev (Neda Knibb) is approved by FDA in October 15, 2014, is the first U.S. listed drug treatment IPF (pirfenidone and Neda Knibb also received FDA approval).
In July 2015, Neda Knibb was included in the ATS/ERS/JRS/ALAT diagnosis and treatment of idiopathic pulmonary fibrosis international evidence-based guidelines recommend medication, when sales are rushing to 300 million euros in 2016 doubled Ofev sales reached 613 million euros, the first half of 2017 reached 429 million euros.
After obtaining the CFDA approved IPF drugs only pirfenidone in Chinese. Neda Knibb is the second effective drug approved by CFDA for the treatment of IPF, which is only 3 years later than the listing in the United states. It is worth mentioning that the 1.1 types of drugs Yifeini ketone domestic pharmaceutical companies developed east sunshine in the treatment of IPF received orphan drug status granted by the FDA in August 10th.