Junshengtai HTD1801 officially launches clinical trials in China

Shenzhen Junshengtai Biotechnology Co.
, Ltd.
(referred to as "Junshengtai") today announced that its self-developed HTD1801 PK bridging test in the Chinese population has completed the enrollment and administration of the first batch of subjects
.

Shenzhen Junshengtai Biotechnology Co.
, Ltd.
(referred to as "Junshengtai") today announced that its self-developed HTD1801 PK bridging test in the Chinese population has completed the enrollment and administration of the first batch of subjects
.

The trial will successively enroll 24 healthy subjects, aiming to evaluate the safety, tolerability and main pharmacokinetic (PK) characteristics of HTD1801 in Chinese healthy subjects, as a comprehensive promotion of the treatment of HTD1801 in China 2 The basis of clinical trials for type diabetes and other metabolic diseases
.

The trial will successively enroll 24 healthy subjects, aiming to evaluate the safety, tolerability and main pharmacokinetic (PK) characteristics of HTD1801 in Chinese healthy subjects, as a comprehensive promotion of the treatment of HTD1801 in China 2 The basis of clinical trials for type diabetes and other metabolic diseases
.

HTD1801 has completed two phase II clinical trials in North America (respectively for primary sclerosing cholangitis and non-alcoholic steatohepatitis with type 2 diabetes), and both reached the primary clinical endpoints and key secondary endpoints, and performed well.
The safety and tolerability
.

In May of this year, HTD1801 was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration to carry out clinical trials in China to improve the blood glucose control of patients with type 2 diabetes, further accelerating the global simultaneous development of HTD1801

Dr.
Liping Liu

Dr.
Liping Liu

Founder and CEO

Founder and CEO

"The pathogenesis of metabolic and digestive diseases is complex and often accompanied by multiple organ comorbidities
.

This complexity determines that clinical treatment needs to consider the comprehensive benefits of patients

Diabetes is one of the fastest growing health problems in the 21st century.
China is the world's largest country with diabetes, most of which are type 2 diabetes patients, and the number is increasing year by year
.

According to the "Expert Consensus on the Management of Type 2 Diabetes and Non-alcoholic Fatty Liver in Adults in China" published in July 2021, about 49%-62% of patients with type 2 diabetes are associated with non-alcoholic fatty liver (NAFLD), namely There are nearly 70 million type 2 diabetes patients with non-alcoholic fatty liver (T2DM+NAFLD) in the country

HTD1801 has been shown in completed clinical studies to improve glucose and lipid metabolism, reduce weight, reduce liver fat, and improve liver function.
It has the potential to bring comprehensive therapeutic benefits to patients with type 2 diabetes and non-alcoholic fatty liver
.

Junshengtai will pay great attention to the therapeutic benefits of such patients in the follow-up clinical development in China

#  AboutHTD1801 #

About HTD1801

HTD1801 is the world's first class 1.
1 oral small molecule new drug independently developed for metabolic and digestive system diseases.
It is the first drug to use "multi-channel synergistic therapy" in the field of metabolism and digestive system
.

Through the dual-track layout of major diseases and rare diseases, the company deeply explores its huge therapeutic potential in a variety of metabolic and digestive system indications
.

HTD1801 simultaneously develops primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), non-alcoholic steatohepatitis with type 2 diabetes (NASH + T2DM), and type 2 diabetes with non-alcoholic disease Fatty liver disease (T2DM+NAFLD) and other indications
.

HTD1801 has won the national "13th Five-Year Plan" "Major New Drug Development" major science and technology special support; and has been granted by the US Food and Drug Administration (FDA) 2 rapid review channel qualifications and 1 orphan drug qualification
.

Junshengtai is a clinical stage biotechnology company based on innovation from the source
.

In response to the major unmet clinical needs of complex metabolic and digestive diseases, the patient-centered, simultaneous development of "First-in-Class" innovative drugs worldwide; with the concept of "multi-channel synergistic therapy", to achieve comprehensive benefits for patients