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Today, Hepanova announced that its class 1 innovative drug HPN-01 intestinal capsule has been approved for clinical trials by China's State Drug Administration (NMPA), a non-alcoholic fatty hepatitis (NASH).
HPN-01, a "first-in-class" candidate developed by Heplin Pharmaceuticals, was approved for clinical approval in the United States in February.
Hepharma was established in 2017 to develop and commercialize innovative drugs for chronic liver disease.
the company has established a wealth of new drug research and development pipeline, covering NASH, liver fibrosis, chronic hepatitis B (HBV) and primary liver cancer (HCC) and other liver diseases.
HPN-01 is the company's own research and development of a "first-in-class" candidate for the treatment of non-alcoholic fatty liver disease, non-alcoholic fatty hepatitis and accompanying liver fibrosis.
HPN-01 can regulate and block the occurrence and development of NASH in a number of important paths, not only effectively reverse liver fat change, but also can alleviate inflammatory reactions and lipid peroxidation in the liver, thereby improving liver fibrosis and liver insexuality.
, HPN-01 was approved for clinical trials by the FDA.
hpN-01 is currently conducting Phase 1 clinical trials in the United States.
According to the press release, this is a randomized, double-blind, placebo-controlled, sequential parallel group, single-dose and multi-dose increment (SAD/MAD) study that plans to recruit 72 healthy subjects to assess the safety, toerability, pharmacodynamics, pharmacological and pharmacological dynamics of the oral small molecule drug HPN-01.
trial is expected to be completed in the first half of 2021.
For HPN-01 intestinal capsules approved clinically in China, Professor Li Coe, co-founder and chairman of Hep chemical medicine, said: "NASH is an area of great concern, in which many pharmaceutical companies are involved in the development of treatments based on different targets and mechanisms of action.
as a member, we are pleased that HPN-01's IND application in China has been successfully approved, another important milestone in Hep's journey to develop innovative drugs worldwide.
we will continue to make every effort and effective effort to advance clinical research on the drug, benefiting the vast number of NASH and chronic liver disease patients worldwide as soon as possible.
HPN-01, an innovative drug based on new target research, is expected to break through the current global NASH and liver fibrosis without the availability of first-line therapeutic drugs, the successful implementation of industrialization of social and economic benefits.
" NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), accompanied by inflammation and liver fibrosis, which can directly lead to cirrhosis, liver cancer, affect the progression of other chronic liver diseases, and is closely related to the onset of type 2 diabetes, coronary heart disease and chronic kidney disease.
currently, there are no drugs approved worldwide for the treatment of NASH.
NASH research can make an early breakthrough and bring treatment options to patients.
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