4 big pharmaceutical giants have hit the wall, $40 billion market into the "sky pavilion"?

Guide: New drugs are rejected, three phases of frequent failure, NASH first ray of light where?1, the first NEW DRUG NASH was rejectedIntercept Pharmaceuticals has long been a leader in non-alcoholic fatty hepatitis (NASH), working to win the first new DRUG, but its OCA has been delayed in the FDA filing processYesterday, the company received a full response letter from the FDA (CRL)THE FDA rejected the OCA application for THE treatment of NASH on the grounds that the FDA believes the benefits of OCA at the mid-term histopathological endpoint are still uncertain, and recommended that Intercept submit additional interim analysis validity and safety data from the ongoing REGENERATE study to support the potential accelerated approval of OCA, noting that the long-term results of the study should continue, Intercept's shares fell about 39 percent on Monday on the newsShares of other drugmakers, which also develop NASH, also fell, with Madrigal down about 6 percent and Viking, Akero and GenFit down about 1 percent each2, Obechocholic acid market bumpyFebruary 19, 2019, Intercept announced that Obechochoricacid (OCA) for patients with 2-3 levels of liver fibrosis non-alcoholic fatty hepatitis (NASH) patients achieved positive results in the mid-term analysis of REGENERATEOCA reached the primary endpoint, liver fibrosis improved significantly, and after 18 months NASH did not deteriorate (p s 0.0002)Obechochoricic acid is the first new NASH drug to succeed in Phase III studiesSeptember 27, 2019, Intercept filed a listing application with the U.SFDA for a new drug for the use of its innovative drug, obecholic acid, for fibrosis caused by NASHNovember 25, 2019, Intercept announced that the FDA had accepted the company's NDA application and had been granted priority review status, with a PDUFA date of March 26, 2020on January 13, 2020, Intercept issued "Intercept Provides Regulatory Update", stating that experts would review Intercept's NDA application on 22 April 2020June 29, 2020, Intercept announced that the FDA rejected applications for new drugs for the use of obelcholic acid for NASH-induced fibrosisNEW DRUG NASH, Phase III Black Hole? non-alcoholic fatty hepatitis (NASH) is a chronic progressive liver disease caused by the accumulation of fat in the liver, which can lead to cirrhosis, liver failure and hepatocellular carcinoma No drugs for non-alcoholic fatty hepatitis have been approved, and there is plenty of market space Evaluate Pharma predicts that the global MARKET for NASH drugs could reach $40 billion by 2025 The huge market size has attracted many pharmaceutical companies, but most of them are in a very early stage International is the first of eight pharmaceutical companies to be attracted, of which obechidic cholicacid was the first new DRUG to succeed in key Phase III studies The rest of the leading layout of NASH companies, have encountered obstacles, the industry has even called NASH after Alzheimer's disease, another Phase III black hole Company: Genfit Drug Name: Elafibranor Mechanism: PPAR alpha and double agonis stage: Phase 3 May 11, 2020, the interim results of the trial results of Genfit's Elafibranor RESOLVE-IT Phase III clinical trial said: "
this trial did not reach the intended end point of the primary ." The news sent Genfit's shares down 68 per cent and the market value evaporated by half : Gilead drug names: selonsertib, firsocostat, and cilofexor
mechanisms: ASK1 inhibitors, ACC inhibitors, FXR agonists stages: Phase 2 February 2019 Selonsertib failed to improve fibrosis in two phase 3 trials involving more than 1,600 patients December 2019, Gilead's NASH Phase II clinical failure, the study recruited 392 patients with severe fibrosis, comparing the effects of ACC2 inhibitor firsocostat, FXR receptor agonistscilofexor, the combination of both drugs, and the combination of ask1sel inhibitors onsertible, and placebo, respectively, to improve fibrosis, and the results did not to achieve the main end point of the study : Novartis Drug Names: Tropifexor and Licogliflozin Mechanism: FXR Agonists and SGLT1 / 2 Inhibitors Phases: Phase 2 and 2a Subsequent Steps: Two Prospects in Combination with Drug Testing, Which works through different mechanisms, to determine the NASH method for each drug June 25, 2019, Novartis amricasan's phase II study ENCORE-L for non-alcoholic fatty hepatitis (NASH) F failed to reach the main end point At present, Novartis tropifexor and licogliflozin are jointly used in the treatment of non-alcoholic fatty hepatitis, and have been undertheed in four clinical trials in China : AstraZeneca Drug Name: Cotadutide Mechanism: GLP-1 /Glucagon Receptor Dagogen Phase: Phase 2 Next data: Potential Clinical Trials in NASH
Company: Allergan Drug Name: Ceniciroc
Mechanism: 2/5 CCR Double adhesus
Phase: Phase 3 Next Data: AURORA Data expected for Q4 2020 Company: NGM Biopharmaceuticals Drug Name: Aldafermin Mechanism: FGF19 Similarity Stage: Phase 2b
Next Reading: Preliminary data from Phase 2b 2/3 study by the end of 2020 : Zydus Cadila Drug Name: Saroglitazar Mechanism: PPAR alpha and gamma double agonist stage: Phase 2 next data: The potential phase 3 research in NASH several of the world's leading pharmaceutical companies, have hit the wall, its NASH drug trials either do not reach Phase III, or Phase III trials often fail, the only successful phase III trial of THE new NASH drug NASH bile acid application is also rejected at present, there are nearly 20 enterprises in China layout NASH new drugs These include Clarion Pharmaceuticals, Tuo-Tai, Jun Shengtai, Micro-Core Biology, Zhengda Sunny, Paige Bio and so on 's FASN inhibitor TVB-2640 will present its latest clinical and preclinical data at the European Society for The Study of The Liver (EASL) International Liver Congress 2020 (ILC) in London early May, Junsanti also announced that its original new drug HTD1801 had reached major and several major secondary endpoints in phase IIA clinical trials in patients with non-alcoholic fatty hepatitis (NASH) combined type 2 diabetes (T2DM) Detailed results will be published at international academic conferences and professional journals .