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June 2, 2021, Shenzhen, China and Rockville, Maryland, USA-Shenzhen Junshengtai Biotechnology Co.
, Ltd.
("Junshengtai") today announced that HTD1801 is used for the treatment of primary biliary cholangitis (PBC).
) The first patient was enrolled in the second phase of the clinical trial
.
This trial conducted in the United States aims to evaluate the safety and effectiveness of HTD1801 for the treatment of PBC
.
The primary clinical endpoint is the change in the biomarker of cholestasis "alkaline phosphatase"; the secondary endpoint includes changes in other biomarkers such as cholestasis and liver function
Dr.
Liping Liu, Founder and CEO of Junshengtai, said: “With the effective prevention and treatment of viral hepatitis such as hepatitis B and C, non-viral chronic liver diseases such as cholestatic liver disease and fatty liver have become liver cirrhosis, liver cancer, and liver disease.
The main cause of transplantation is a serious hazard to human health
.
Previously, HTD1801 has achieved positive results in two clinical trials of primary sclerosing cholangitis and non-alcoholic steatohepatitis combined with type 2 diabetes.
Primary biliary cholangitis (PBC) is a chronic immune liver disease.
The main cause is cholestasis caused by autoimmune destruction of the bile ducts
.
The disease is accompanied by inflammation and injury of the intrahepatic bile ducts.
About HTD1801
HTD1801 is the world’s first new molecular entity that is simultaneously developed globally for the treatment of primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), non-alcoholic steatohepatitis and type 2 diabetes ( NASH & T2DM), type 2 diabetes and its comorbidities and other indications
.
In two completed Phase II clinical trials (for PSC and NASH & T2DM, respectively), HTD1801 reached the primary clinical endpoint and key secondary endpoints, and demonstrated good safety and tolerability
.
Recently, HTD1801 has also been approved by the Center for Drug Evaluation (CDE) of the State Drug Administration in China to carry out clinical trials of indications for blood glucose control in patients with type 2 diabetes, further accelerating the global simultaneous development of HTD1801
HTD1801 received the national "13th Five-Year Plan" "Major New Drug Development" major scientific and technological support; and was granted by the U.
S.
Food and Drug Administration (FDA) 2 rapid review channel qualifications (respectively for PSC and NASH), 1 orphan drug Qualification (for PSC)
.
About Junshengtai
Junshengtai is a clinical-stage biotechnology company based on innovation from the source, focusing on the development of original innovative drugs for chronic liver disease, metabolism, digestion and other major unmet clinical needs, the deployment of global patent protection, and the simultaneous development of "First-in-Class" globally.
"Innovative medicine
.
For more details, please visit the company website: https://hightidetx.
Company Contact:
Investor Relations
Jeffrey Dao ir@hightidetx.
Media relations
Grace Zhang media@hightidetx.
