Hengrui "Obe bile acid film" newspaper listing domestic enterprises have not yet been approved

Obeticholic Acid, OCA.
product name Ocaliva) was developed by Intercept Pharmaceuticals and was first approved by the U.S. FDA on May 27, 2016, with sales of $12.36 million for the year; Approved by the European Union on February 12th, it became the first drug approved to treat PBC in nearly 20 years, and EvaluatePharma predicts that global sales of the drug will reach $2.992 billion by 2020.
Primary bileitis (PBC), also known as primary bile cirrhosis, the incidence rate of 3.3-5.8/million people, the prevalence rate is 19-402/million people, is a rare disease, but the prevalence rate increased year by year, has been awarded fast-track and orphan drug qualification by the FDA.
it is understood that bear deoxycholic acid (UDCA) is currently the only approved drug for PBC treatment, UDCA can effectively treat more than 50% of PBC patients, but more than 40% of patients have a poor response to it, 5% to 10% of patients can not withstand UDCA.
clinical advantage of oxytolic acid is that it can significantly improve biotransmissment indicators for patients with poor or insatiable UDCA treatment, delay disease progress and improve survival.
as a second-line treatment drug for PBC and is expected to replace the therapeutic status of UDCA.
addition, the most promising and important adaptive condition for Oberic acid is non-alcoholic fatty hepatitis (NASH), and on November 25, 2019, Intercept filed a listing application for Obecholic acid treatment for liver fibrosis caused by NASH and was accepted by the FDA, with a PDUFA date of June 26, 2020.
, however, the FDA declined to approve this year, arguing that the benefits of interim histological endpoint data remain uncertain and recommending that Intercept provide ongoing REGENERATE follow-up validity and safety data to assess whether the benefit risk ratio has been achieved.
Insight database shows that the original drug is not listed in China, at present, including Hengrui, a total of 2 companies reported for listing, the other is Nanjing Tianqing, 5 enterprises are in the BE trial stage, respectively, Colum Pharmaceuticals, Chengdu Nt, Yangzijiang Pharmaceuticals, Shanghai Fudan Zhangjiang Biopharmaceuticals, Zhengda Tianqing.
from: Insight Database () In addition, in June 2019, Nanjing Zhengda Tianqing submitted a category 3 application for the listing of Obe bile acid tablets, but finally obtained clinical tacit permission to complete the BE trial and then re-listed on May 18 this year;
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