The first adjuvant dermatitis targeted biologics: Sanofida® ® approved in China for treatment of moderate to severe adult patients!

, June 22, 2020 /
BiovalleyBIOON/Sanofi) recently announced that China's State Drug Administration (NMPA) has approved Dabito ® (English name: Dupixent®, generic name: Dopriu monovirus, dupilumab) for the treatment of adult moderate to severe teritoma (AD)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 dermatitisThanks to the drug regulatory reform, The ® was approved in China two years ahead of schedule, providing chinese patients with a new treatment optioninnovative mechanism of "double-target" to fill the unmet needs of Chinese clinicalatopic dermatitis (atopic dermatitis, AD) is a refractive, recurrent, inflammatory skin disease, with recurrent severe itching and rash as the main clinical manifestations, patients often combine allergic rhinitis,asthmaand other special diseasesMost patients have symptoms of pain and discomfort caused by skin cracking, cosking and seepage, which, if not effectively controlled, can affect the emotional and psychological state of the patient, leading to anxiety and depression, and lonelinessSome patients have said that 12 hours do not stop the intense itching in the night the most difficult, can only keep scratching, with pain cover itching, a normal sleep is a luxury"In China, the prevalence of aspecial dermatitis and the severity of the burden of disease are one of the highest among skin diseases," said Professor Zhang Jianzhong, director of the dermatology department at Peking University People's Hospital,the 13th session of the Chinese Medical Association's Dermatological SocietyTreatment is still dominated by external medications such as localized external glucocorticoids, oral glucocorticoids and immunosuppressants, and lacks effective and safe meansPatients with moderate to severe adhesion dermatitis and their families suffer from the physical, life and spirit of the disease and are in urgent need of safe, effective and long-term generally available treatment"
Dabito ® is an all-human monoclonal antibody, through the "double target" innovative mechanism of action, selectively inhibit the key signal path leukin4 (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 diseasesData from theof clinical trials at Dabitto ®
show that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays a major role in diseases such as aditial dermatitis,asthmaand chronic nasal-sinusitis associated with nasal polyps (CRSwNP)Dabito ® has good safety and tolerance, can quickly, significantly, and continuously alleviate itching, skin damage and other symptoms at the same time, effectively improve the quality of life of patientsIn February, China's guidelines for the treatment of specific dermatitis (2020) were published, recommending the unlisted ® da Bito in the hope that the new drug would fill the current demand for the drugthe Chinese Medical Association dermatological diseases credit committee-designate, the Chinese Medical University affiliated with the First Hospital Vice President Professor Happy Hua said: "As a targeted therapy, Dabito ® approved in China's aspecific dermatitis diagnosis and development process has a breakthrough significance, but also for patients with aspecial dermatitis brought hope, is expected to help them get rid of unbearable itching, skin damage, improve the quality of life of patients and their families to help them return to normal life." "
-specific dermatitis (photo: icresearch.net) was introducedinnovative drugs, and was quickly approved in China two years in advance
based on positive dataclinical trials of the global LIBERTY AD, which enrolled nearly 3,000 patients with disease control in the groupThe trial assessed the safety and efficacy of dabit® (single-drug therapy or associated with local glucocorticoids), including skin loss removal, overall disease severity and itchingin order to meet the urgent treatment needs of patients with tertomatin, so that domestic patients enjoy the world's leading innovative drugs earlier, thanks to the "National Nine", Dabito ® was introduced in February 2019 Boao Super Hospital Dermatology Clinical Medical Center, a patient with moderate to severe adhesion dermatitis was the first to receive the first injectionThanks to the continuous push of the reform of the National Drug Administration, Dabito ® was included in the second batch of clinically urgently needed new drugs from the Drug Review Center (CDE) of the State Drug Administration in May 2019, accelerating the process of listing and approval, two years ahead of schedule Paul Hudson, chief executive of Sanofi, said: "Sanofi has deep roots in China, which has always been an important growth market The deepening of China's medical system reform has also paved the way for innovative drugs such as ® to benefit patients earlier We will respond positively to the 'Healthy China' 2030 program and expect to introduce more than 25 innovative drugs and vaccines by the end of 2025 for the benefit of more Chinese patients "Patients first, scientific leadership is the work of us, sanofi is proud to bring an innovative treatment program to China," said Wang Baikang, general manager of Sanofit Pharmaceuticals Global, The approval of the ® in China means that this 'type 2 inflammatory disease treatment' has entered the age of biologics in China, which will help patients suffering from the disease return to normal life We sincerely thank the Chinese government for its efforts to accelerate the introduction of innovative drugs and pay tribute to the long-standing support of experts from all sides We will do our utmost to make Dabito ® reach patients as soon as possible "
under a global cooperation agreement, Dabitor ® developed jointly by Sanofi and Regeneron March 2017, Dabitor ® approved its listing, becoming the world's first biological agent for the treatment of moderate-to-severe adhesitis To date, the drug has been approved by more than 40 countries and regions around the world, including the United States, the European Union and Japan In the United States, Dupixent is now approved for treatment of three diseases caused by type 2 inflammation: moderate to severe aditary dermatitis (in patients aged 6), moderate to severe asthma (in patients with 12 years of age), and chronic sinusitis (CRSwNP, adult sinus) currently, Sanofi and Regenerative Element are also conducting an extensive clinical project to assess Dupixent's treatment of diseases caused by allergies and other type 2 inflammations, including: asthma in children (6-11 years, Phase III), specialder dermatitis in children (6 months to 5 years, II /III), eosinophilic esophagitis (Stage III), chronic obstructive pulmonary disease (Stage III), large herpes (Phase III), nodule itch rash (Phase III), chronic spontaneous urticaria (Stage III), food and environmental allergies (Phase II) Dupixent is another important product that Sanofi has developed in collaboration with The Regenerative Element sepsis praluent, a pcSK9 inhibitor class, and a game-changing drug Dupixent's indications are steadily increasing, with Evaluate Pharma, a leading pharmaceutical market research firm, predicting global sales could reach $8 billion in 2024 (BioValleyBioon.com) original origin: Sanofi .