Clinical applications for the treatment of primary dryness syndrome by the acoustic pharmaceutical company "Elamod tablets" were approved.

On September 8th, Iramod tablets, a new anti-rheumonic drug developed by Synractic Pharmaceuticals, were developed (trade name: Edsin? Applications for clinical trials of new drugs for the treatment of primary dryness syndrome (pSS) (acceptance number CXHL2000340/1/2) were approved.
Iramod tablet was first listed in the world in 2011 and is the first class 1.1 anti-rheumatoid new drug with fully independent intellectual property rights in China, enriching the choice of small molecule therapy drugs for rheumatoid arthritis.
the clinical application was approved, Edsin (Eramod tablets) is expected to become the first drug in the country to treat primary dryness syndrome, which is the first new adaptation to be developed after approval to treat rheumatoid arthritis.
primary dry syndrome is another chronic, systemic, autoimmune disease in addition to systemic lupus erythematosus and rheumatoid arthritis.
the main characteristics of the disease are exocrine glands suffering, common clinical manifestations of dry mouth, dry eyes, fatigue and joint pain and other symptoms, these three symptoms are found in more than 80% of patients, greatly affecting the quality of life of patients.
pSS is mostly middle-age female patients, the total prevalence rate is about 61 per 100,000, the total prevalence rate of the population in China is about 0.29%-0.77%, the total number is expected to be about 4-10 million.
treatment of pSS has not made significant progress compared to other autoimmune diseases compared to other autoimmune diseases, there are no treatment guidelines based on high-quality grade evidence, and there is no classical evaluation criteria for treating pSS.
, there is no drug-based pSS adaptation worldwide, and there is a huge clinical unsealed need for pSS treatment.
Since pSS does not have satisfactory treatment measures, whether dry, tired, painful or visceral organ damage, there is a lack of proven and effective drugs, especially those used to control and delay system damage, most of the drugs used are empirical treatments, or the treatment of similar lesions.
Clinically mainly or the use of mouth and tears alternative treatment to improve dry mouth and dry eyes symptoms, the use of nonsteroidal anti-inflammatory analgesics to reduce muscle, joint pain, etc. , these treatment can alleviate the symptoms of patients to a certain extent, but can not really alleviate the disease process, and for other important organs affected patients with poor efficacy.
pathogenesis of pSS is not yet clear, more than 20 chemicals and biologics worldwide are currently in the process of developing pSS therapy.
Despite the endless development of pSS treatments, there is a lack of specific treatment drugs, and most of the slow progress (no drugs entering phase III clinical trials), there is an urgent need to rapidly advance the development of highly effective pSS treatment drugs.
new DMARD Iramod mechanism has been shown to inhibit B cells from producing immunoglobulins by regulating the protein kinase C/early growth reaction factor 1 (PKC/EGR1), while also inhibiting IL-17 and NF-B signaling pathways, suggesting that Elamod has a mechanism basis for treating pSS.
The Ellamod Treatment pSS section has published a research profile At present, Elamod Therapeutic pSS has gradually accumulated a number of clinical data, showing that Elamod can effectively improve the pSS patient disease activity and indicators, and good safety, confirming the therapeutic value of Elamod to pSS.
On the basis of a large amount of clinical evidence in the early stage, Eramod has officially entered china's "Primary Dry syndrome diagnosis and treatment Norms" in April this year, and today was officially approved for primary dry syndrome IND, is expected to become the first primary dry syndrome written in the specification of the drug.
2011 Class 1.1 innovative drug Edsin? The successful listing of (Eramod tablets) is a milestone in the innovation and development of the acoustic pharmaceutical industry, which has opened the upward development track of the sound pharmaceutical industry to continuously build a research and development pipeline and launch innovative drugs.
more than
years, Synthe Pharmaceuticals has focused on source conversion innovation, deep-rooted innovative pharmaceutical field, this year has been listed two heavy innovative pharmaceutical products: bio-innovative drug Enrschura? (A basip injection), 1 class of innovative drugs must be new first? The heavy drugPD-L1 inhibitor KN035 (Envafolimab) is also expected to be available in 2021.
In addition to these three heavy-weight drugs, there are nearly 50 innovative drugs at different stages of research in the three major areas of tumor disease, central nervous system disease and autoimmune disease.
in the field of autoimmune diseases, except for the listed Edsin? (Ella Maude), Enrsch? (A basip injection), Aitavi? ( acid tofatic cloth tablets), Ying Taiqing? In addition to the sodium bichlorofenate capsules/gels, there are three products under study, the product layout is becoming more and more perfect, has gradually become an innovative benchmark in the field of autoimmune diseases, and effectively bring more accurate, safe and effective drugs for patients with autoimmune diseases.
, a pharmaceutical company that is rapidly transitioning to innovation-driven, is committed to "making more effective drugs possible for patients early" with leading research and development and commercialization capabilities.
believe this time Adesin? The approval of THED for the treatment of primary dryness syndrome will greatly advance the field of treatment and bring good news to millions of patients.
references, Ye Y, Liu M, Tang L, et al. Iguratimod represses B cell terminaldifferentiation linked with the resedion of PKC/EGR1 axis. Arthritis Research and Therapy, 2019, 21 (1): 92. Luo Q, Sun Y, Liu W, et al. A Novel Disease-Modifying Antirheumatic Drug, Iguratimod, Ameliorates Murine Arthritis by Blocking IL-17 Signaling, Distinct from From Methotrexate and Leflunomide. The Journal of Immunology, 2013, 191 (10): 4969-4978. Aikawa Y, Yamamoto M, Yamamoto T, et al. An anti-rheumatic agent T-614 resneds NF-kappaB activation in LPS-and TNF-alpha-excitinged THP-1cells without interfering with Ikappa Balpha reed. Research : official journal of the European Histamine Research Society , 2002, 51 (4): 188-194. R. Felten, F. Scher, J. Siblia, et al, AutoimmunityReviews.2018.12.008 Source: Medical Rubik's Cube !-- Content Presentation End -- !-- Judge Whether to Log In End.