China's special dermatitis new drug! Pfizer Shutmin (Cliborro): The first non-hormonal external PDE4 inhibitor, approved by the National Drug Administration!

02, 2020 // Pfizer has announced that China's State Drug Administration (NMPA) has officially approved a 2% certificate of imported drug registration for suttamin (Kliboro) ointment.
Schutamming is approved for local external treatment in China for patients with mild to moderate termatitis (AD) aged 2 years and older.
-specific dermatitis (AD, also known as a reactive eczema) is the most common chronic inflammatory skin disease, characterized by recurrent chronic eczema-like rashes, accompanied by significant dryness and itching of the skin.
worldwide, up to 10% of adults and 20% of children suffer from episophinis.
with the changes in lifestyle and environment, the prevalence of aspecific dermatitis in China has been increasing in the past 10 years, and the affected populations are of all ages.
China's guidelines for the diagnosis and treatment of especialderderitis (2020) pointed out that the prevalence rate of especially epidermatitis reached 12.94% in children aged 1-7 years in 12 cities of China, and 30.48 percent of infants in January-December.
-specific dermatitis (photo source: diseaseslab.com) The skin manifestations of especialderitis can continue into adulthood.
skin loss is mostly within 2 years of age, children will appear skin loss and severe itching, seriously affecting their sleep and growth and development;
adult-specific dermatitis is usually accompanied by obvious itching symptoms, epidermal peeling, blisters, oozing and slurry-based knots, can cause patients emotional burden, insomnia, depression and anxiety and other mental illnesses, resulting in the decline of productivity and social function slower or even loss, seriously affecting the quality of life of patients.
Sutamin (Cryo) 2% ointment is a new type of small molecule, non-hormone, nonsteroidal anti-inflammatory phosphodiesterase 4 (PDE-4) inhibitor, over-activated PDE-4 has been shown to be associated with the symptoms and signs of aditonal dermatitis.
Suttamin (Kliborro) 2% ointment 2016, Suttamin obtained the U.S. Food and Drug Administration (FDA) approval for the treatment of patients 2 years and older, the product in the United States is called EUCRISA, north-west of the product called STAQUIS.
2020, the FDA approved local treatment of its indications to children and adults aged 3 months and older with mild to moderate lypitis.
, Suttamin has been approved in the United States, Canada, Australia, Israel and the European Union for the treatment of especially defectist.
benefitfrom the Promotion of NMPA-related policies, Schutamming entered China through a fast-track approval channel, and the approval of the drug marks an important milestone that will fill the unmet treatment needs of Chinese children with aspecific dermatitis, providing an opportunity to alleviate symptoms for the majority of Chinese patients with aspecific dermatitis, especially children 2 years and older.
it's worth noting that in June this year, Sanofi's Dabitu ® (Dupixent®, generic name: Dupreu monotomatin, dupilumab) was approved in China for the treatment of moderate to severe adhesion dermatitis (AD) in adults.
February this year, "China's specialder dermatitis treatment guidelines (2020)" issued, the not-yet-listed Dabitor ® included in the recommendation, in the hope that the new drug will fill the current drug can not meet the demand.
Dabitor ® is the world's first and only approved treatment of adults with moderate to severe adhesion dermatitis targeted biologics, to fill the domestic clinical lysacitof, can quickly, significantly, and continuously improve the degree of epithelial and itching symptoms of patients with aspecific dermatitis.
thanks to the drug regulatory reform, the ® was approved in China two years in advance, providing chinese patients with a new treatment option.
Dabito ® is an all-human monoclonal antibody, through the "double target" innovative mechanism of action, selectively inhibit the key signal path leukemeyin 4 (IL-4) and interleukin 13 (IL-13), block the type 2 inflammatory pathway, reduce the pathological response of type 2 inflammation, from the mechanism of treatment of type 2 inflammatory-related diseases.
Dabitor ® developed jointly by Sanofi and Regenerative Elements, the drug has been approved to treat three diseases caused by type 2 inflammation: moderate to severe adhesion dermatitis (patients aged 6 years), moderate to severe asthma (patients aged 12 years), chronic sinusitis (CRSwNP, adult patients).
() Original origin: Pfizer, Sanofi.