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).
Devassaban Particles/Dry Suspension Devasalban is a non-vitamin K antagonist oral anticoagulant developed jointly by Bayer and Janssen in the dosage 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 listing 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.
dupilumab, a human-origin monoclonal antibody developed by Sanofi, 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 adaptation to be included in the priority review this time is "severe endemic dermatitis in adolescents and adults 12 years of age and older who have poor control of prescription drugs for external use or are not recommended for use in prescription drugs for external use" and is the second symptom of monotherapy.
Dupixent ®) can block both IL-4 and IL-13 signaling path paths by binding IL-4R alpha, and IL-4 and IL-13 are considered to be the main drivers of persistent inflammation of endexual dermatitis.
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;
dermatitis is a common relapsed, chronic inflammatory skin disease, which is usually characterized by a chronic rash 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 is not much 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 specific dermatitis in China is very limited, topical hormones and other topical therapies for patients with moderate to severe endexual dermatitis is 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.
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