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On November 22, Salubris announced that the clinical trial application of SAL0119 tablets, an innovative small molecule drug independently developed by the company, was accepted, and the clinical indications currently planned to be developed include active ankylosing spondylitis and moderate to severe active rheumatoid arthritis
.
Up to now, Salubris has declared 4 Class 1 new drugs
this year.
Figure 1: Salubris latest product declaration
Source: CDE official website
Salubris mentioned in the announcement that SAL0119 tablets are an oral small molecule immunosuppressant, and clinical indications are currently planned to be developed for active ankylosing spondylitis and moderate to severe active rheumatoid arthritis
.
Ankylosing spondylitis (AS) and rheumatoid arthritis (RA) are both autoimmune diseases whose causes are not fully understood and cannot be cured
.
SAL0119 has a unique mechanism of action different from JAK and broad-spectrum cytokine inhibition, and preclinical research data show good efficacy and safety
。
Figure 2: Sales of immunosuppressants in China (RMB 10,000)
Source: Minai Grid Bureau database
In recent years, as more and more new products have been approved to enter the market, the overall sales scale of immunosuppressants has risen rapidly, Minai.
com data shows that in 2021, the total sales of immunosuppressants in the six major markets of the three major terminals (see the end of the article for statistical scope) have exceeded 25 billion yuan, public hospital terminals (urban public hospitals + county-level public hospitals) are the main battlefield, accounting for more than eighty percent, retail pharmacy terminals (urban physical pharmacies + online pharmacies) have grown rapidly, maintaining double-digit growth
in the past two years 。
Figure 3: Salubris has declared Class 1 new drugs since the beginning of this year
Source: Minainet new version of the database
Up to now, Salubris has declared 4 Class 1 new drugs this year, among which recombinant human neuromodulator 1-anti-HER3 antibody fusion protein injection and SAL0112 tablets have been approved for clinical trials
.
It is reported that recombinant human neuromodulin 1-anti-HER3 antibody fusion protein injection is the first innovative biological drug reported by Salubris in China and the United States, and the HFrEF (heart failure with preserved ejection fraction) indication is currently undergoing phase I clinical studies
in China and the United States.
SAL0112 tablets are an oral small molecule biased agonist of GLP-1R, which has been approved for clinical use for
weight management in type 2 diabetes, adult obese patients or overweight patients.
SAL008 injection is a fusion protein of IL-15/IL-15Rα complex and anti-CTLA-4 antibody, which is intended for the treatment of advanced solid tumors, and the clinical application of new drugs in China is currently under review and approval
.
After the new drug was submitted for CTA (European Clinical Trial Application) in Europe, phase I clinical studies
have been initiated.
Source: CDE official website, company announcement, Minainet database
Note: Minai.
com's "Drug Competition Pattern of China's Three Major Terminal and 6 Major Markets", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of November 23, if there is any omission, welcome to correct!
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