Recently, the American biotechnology company Akaro released positive data on its new NASH drug Efruxifermin in the Phase IIb HARMONY study, which has attracted great attention from the industry, and the drug has once again pushed NASH, the field of disease treatment research and development
.
Non-alcoholic steatohepatitis (NASH) is a serious form of non-alcoholic steatohepatic liver disease and is one of the main causes of cirrhosis, with the incidence of cirrhosis in patients with NASH reaching 15% to 25% within 10 to 15 years, and the patient population is large
.
However, as of now, there are no approved treatments
for this disease.
In China, the NASH drug market space is huge, which has increased from 500 million yuan in 2016 to 700 million yuan in 2020, with a compound annual growth rate of 5.
5%.
According to some data, by 2025, this market is expected to reach 3.
2 billion yuan, and by 2030, it will exceed 30 billion yuan to reach 35.
5 billion yuan, with a compound annual growth rate of 37.
0% and 61.
4%
during the period.
Aiming at the NASH drug market of more than 30 billion yuan, nearly 20 domestic pharmaceutical companies have been laid out, including Geli Pharmaceutical, Tuozhen Biological, Zhongsheng Pharmaceutical, Junshengtai and so on
.
From the perspective of progress, among them, Kolêt Pharmaceutical has an earlier layout in the field of NASH drugs, and the candidate products are abundant
.
In January this year, Graham Pharma announced that its wholly-owned subsidiary, Ganlai Pharmaceuticals, completed a Phase I clinical trial
of its pipeline drug ASC43F in the United States.
ASC43F is a dual-target, fixed-dose compound (FDC) developed entirely in-house by the Company for the treatment of NASH
.
The results of this US Phase I clinical trial show that ASC43F has good safety and tolerability
.
In addition to ASC43F, the company has developed a number of NASH combination therapies, including ASC44F (FASN+FXR), ASC45F (FASN+THRβ), etc
.
And there are many drugs in the clinical stage, such as ASC40 for fatty acid synthetase (FASN), ASC41 for thyroid hormone ß receptor (THR-ß) and ASC42
for farnesol X receptor (FXR).
Among them, ASC40 and ASC41 have been in phase II clinical practice
.
Zhongsheng Pharmaceutical has also been studying NASH drugs in recent years, and the 2021 annual report discloses that the company has laid out 5 NASH treatment products such as ZSP1601, ZSP0678, RCYM001, RAY001 and RAY002, covering different disease stages such as lipid metabolism, inflammation, fibrosis and other different target lines of action with the potential for combined use
.
Among them, a class of innovative drugs ZSP1601 tablets belong to the first-in-class drug, which has completed the Phase Ib/IIa clinical study and is in the preparation stage
of Phase IIb clinical research.
In addition, Tuozhen Biologics, which focuses on innovative therapies for chronic liver diseases such as NASH, has advanced to phase II.
a clinical
treatment with TERN-501 and TERN-501/TERN-101 combination therapies for NASH.
In addition to the above-mentioned pharmaceutical companies, the NASH new drugs/indications of domestic pharmaceutical companies such as Microchip Biologics, Junshengtai and Dongguang Pharmaceutical are actively promoting and have been in clinical phase II, and more than 10 NASH new drugs such as Chia Tai Tianqing, Sihuan Pharmaceutical, Guangshengtang and CSPC Pharmaceutical Group have also entered the clinical phase
I.
It is foreseeable that if the above-mentioned domestic NASH new drugs can be successfully listed, they will share the tens of billions of markets and bring good news
to the majority of patients.
Southwest Securities believes in a recent research report that NASH drugs may be the next city
of tens of billions of drugs after the explosion of tinib, PD-1 pile-up, ADC, and CAR-T wars.
The bank had expected more than 10 NASH drugs to be approved
in the next 10-15 years.
Among them, obeicholic acid (FXR agonist) may be one of the first available drugs for NASH patients if it can address the side effects of itching and elevating low-density cholesterol, and other potential candidates for marketing include THR-β agonists (MGL-3196), PPAR agonists, and GLP-1 receptor agonists (such as somarubine).
