Three children's medications are to be included in the priority review

On October 12, the CDE announced that it intended to include three drugs in its priority review and approval on the grounds that "new varieties, dosage forms and specifications of medicines for children that meet the physiological characteristics of children".
the three drugs are Bayer's "Devassaban Particles" (JXHS2000148/9), Devassaban dry suspension (no acceptance number) and Sanofi's "Dupreyu single anti-injection" (JXSS2000035).
Deva Saban Particles/Dry Suspension Devasalban is a non-vitamin K antagonist oral anticoagulant developed jointly by Bayer and Janssen in the form of tablets, capsules, granules and suspensions.
Among them, tablets in China as early as 2009 to Therrito ® as a commodity name listed, has been approved 5 adaptive diseases, and 5 generic drugs were approved, respectively, Zhengda Tianqing, Shi Pharmaceutical Group, Yangzijiang Pharmaceuticals, Nanjing Zhengda Tianqing, Jiangsu Jiayi.
particulates and suspensions are only submitted by Bayer for listing.
submitted its application for the devassaban particle to market on 25 September and was accepted by CDE.
the adaptation to be included in the priority review is "the treatment of venous thromboembolism (VTE) and the prevention of the recurrence of VTE after the start of standard anticoagulant therapy in newborns, infants, children and adolescents under the age of 18."
, venous thromboembolism (VTE) is a relatively rare disease that is about 100 times less common in children than in adults.
, children's VTE treatment is based primarily on inferences from adult studies.
, there is still a need for new anticoagulant treatments for children with VTE.
puliyu monoantigen injection Dupilumab is a human-origin monoclonal antibody developed by Sanofi that targets IL-4R alpha.
approved by the FDA in March 2017 as the first targeted biological drug for the treatment of moderate to severe endexual dermatitis in adults, and was approved domestically on June 17, 2020 for the treatment of severe endexual dermatitis in adults.
The condition to be included in the priority review this time is "severe endemic dermatitis in adolescents and adults 12 years of age and older who are poorly controlled or not recommended for the use of prescription drugs for external use" and is the second onset of monotherapy.
Dupixent ® is considered to be the main driver of persistent inflammation of endexual dermatitis by binding IL-4R alpha while blocking the IL-4 and IL-13 signaling path path.
March 28, 2017 Dupixent® was approved by the FDA as the first biologic agent to treat moderate to severe specialty dermatitis, with sales of $251 million in its first year on the market;
is a common relapsed, chronic inflammatory skin disease, and patients usually develop chronic rashes characterized by inflammation and itching.
patients with moderate to severe endexual dermatitis usually have red rashes on the skin in very large parts of the body, causing intense and persistent itching, dry skin, colic, seepage, and very limited treatment drugs.
There are not many data on patients with specific dermatitis in China at present, public data show that the prevalence of endexual dermatitis in children in 2016 was nearly 13%, however, the treatment of moderate to severe endexual dermatitis in China is very limited, topical hormones and other topical therapies for patients with moderate to severe endexual dermatitis are limited and difficult to use in the long term, and immunosuppressants or oral corticosteroids and other systemic treatment methods may lead to serious side effects.