Goliath's second class 1 new hepatitis C drug, Ravidavi, was approved immediately.

7.28 Just after World Hepatitis Day, good news came from the hepatitis C pipeline of Gori Pharmaceuticals.
application for the listing of its class 1 new drug, Avidavir tablet hydrochloride (the relevant acceptance number is CXHS1800020), was changed to "in-approval" in the NMPA status, which means that the second new hepatitis C drug from Goliath Pharmaceuticals is about to be approved, following Danolive.
Ravidasvir (ASC16) is a generic-genotype DAA drug targeted by Presidio's Company Lice in September 2014 and was specifically supported by the national "major new drug creation" technology in 2017.
Lavidawe combined with Danorivee and Libawelin (i.e. RDV/DNV treatments) is a full oral interferon-free chronic hepatitis C treatment.
phase II/III clinical trials completed by the
show that the cure rate (SVR12) for 12-week RDV/DNV treatments is as high as 99%, while for patients with baseline NS5A drug-resistant mutations, the cure rate for RDV/DNV treatment options (SVR12) is up to 100%.
with a cure rate of about 60% (SVR24) and a course of treatment of 48 to 72 weeks, Ravidavi has a clear advantage and is a leading NS5A inhibitor of its kind.
In August 2018, Ravidavi's application for listing was accepted by the CDE and subsequently included in the priority review on the grounds of "significant speciality", and now Ravidavi has completed administrative approval, which means it is one step closer to the approval of the second hepatitis C drug.
addition to Ravidavi, there are three other drugs in the goliath pharmaceutical hepatitis C pipeline, namely danolive, ASC21 and ASC18.
, a next-generation NS3/4A protease inhibitor, was approved by NMPA in June 2018 as the first domestic hepatitis C innovative drug.
phase 3 clinical trial results completed in mainland China showed that after 12 weeks of treatment, the cure rate (SVR12) of Danorive reached 97% in patients with non-hepatic cirrhosis of gene type 1.
it is worth mentioning that Gonowe has been included in the basic medical insurance in Zhejiang Province, its 2019 sales reached 124 million yuan, an increase of 72.2% year-on-year, becoming the main source of revenue for the pharmaceutical industry.
ASC18, the first daily oral, one-dose compound preparation (Fixed Dose Complex, FDC) developed by local companies to treat hepatitis C, was approved for clinical trial in August 2019 (acceptance number CXHL1900053) and is currently in Phase I clinical trial phase I.
ASC21 is a nucleoside NS5B polymerase inhibitor.
in-body studies have shown that ASC21 has a general genotype antiviral activity and a high barrier to gene resistance.
combined with Ravidavi to form a treatment option with potential generic genotype activity that can be used to effectively treat patients with resuscidable genotypes, cirrhosis and HCV/HIV co-infections.
March 2019, the drug was approved clinically (acceptance number CXHL1800229) with the condition: in a combined use with other drugs to treat chronic hepatitis C virus infection in adults.
With regard to hepatitis C and DAA, or viral hepatitis C, an infectious disease that causes inflammatory necrosis and fibrosis of the liver due to hepatitis C virus (HCV), it is the leading cause of chronic hepatitis, cirrhosis and liver cancer.
The disease is a global infection, mainly through blood, sexual contact and mother-to-child transmission, according to the WHO released the 2017 Global Hepatitis Report data, there are currently about 71 million people infected with hepatitis C worldwide, because there is no vaccine preventable, the incidence of hepatitis C showed a sharp upward trend.
With the development of medical technology and drug research and development technology, the treatment of hepatitis C can be divided into four stages: general interferon therapy, general interferon combined with libawelin treatment, polyglycol interferon combined with libawelin treatment, direct antiviral drugs (DAA) treatment, in which the discovery of DAA drugs, greatly improve the global level of hepatitis C treatment, so that hepatitis C has become a curable infectious disease.
DAA drug is a class of small molecule-targeted drugs directly acting on HCV, compared with traditional therapeutic drugs, not only good efficacy, short treatment cycle, small side effects, but also through oral administration patients compliance is better.
to date, several DAA drugs have been approved worldwide, which can be broadly divided into three categories depending on the point of action: 1) NS3/4A protease inhibitors such as Porplyvir, Trapivir, 2) NS5B protease inhibitors such as Sofebwe, Darcybwe, 3) NS5A protease inhibitors such as dacarave.
in which NS3/4A serine protease is involved in lysing and shearing multiple points of the HCV virus polypeptide chain, NS5B encodes RNA polymerase in HCV replication process, and NS5A replication complex protein plays an important role in virus replication and assembly process.
china is a country with a high number of hepatitis C infections, but the time to enter DAA drug treatment is relatively late.
china's hepatitis C treatment has only entered the DAA phase since the approval of the 2017 100-time Meishi Shiguibao Berlizer/Quickwip (i.e. DCA/ASV) program.
has approved several DAA drugs in the country so far (see table below).
according to the information in the table, China's hepatitis C DAA drug market is almost monopolized by foreign companies, only Gori's Dano River and Kain Technology's ColoPaiwe two domestic DAA drugs.
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