On December 18, according to the announcement on the official website of the State Food and Drug Administration (NMPA) of China, the new drug methylphenidate hydrochloride extended-release chewable tablets for attention deficit hyperactivity disorder (ADHD, ADHD) jointly declared by You'er Pharmaceutical and Tris Pharma were approved for marketing on December 13.
In July 2022, Youer Pharma and Tris Pharma jointly submitted a marketing application for methylphenidate extended-release chewable tablets under the trade name Quillichew ER, which is the first approved methylphenidate extended-release chewable tablet, and was included in the CDE for priority review for "new varieties, dosage forms and specifications of children's drugs that meet children's physiological characteristics". Studies have shown that Quillichew ER can work within 45 minutes and effectively control ADHD symptoms. In a clinical study, Quillichew ER significantly improved attention and behavior in children with ADHD aged 6 to 12 years.
Epidemiology
Attention deficit hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders in childhood and adolescence. At present, the prevalence of ADHD in children and adolescents aged 6-17 years in China is about 626%, and the number of people affected in the country reached 23 million. ADHD has a serious impact on children's psychological, social function and family relationships, but the drug of ADHD in China is single, and there are problems such as poor compliance and adverse reactions, resulting in a diagnosis and treatment rate of patients far lower than that of developed countries.
Related BD transactions
November 30, 2022 - You'er Pharma and Tris Pharma, Inc(TRIS) today announced that the two companies have expanded their strategic partnership to obtain exclusive rights to commercialize all of TRIS's FDA-approved Attention Deficit Hyperactivity Disorder (ADHD) pipeline products in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan).
Company Profile
You'er Pharma is a local innovative pharmaceutical company focusing on the field of pediatrics, and is committed to introducing and developing safe, effective, convenient and easy-to-use pediatric drugs for Chinese children. The company's existing pipeline covers a number of pediatric indications, including: attention deficit hyperactivity disorder, nocturnal enuresis, systemic acute allergy, asthma and neonatal hemorrhagic prophylaxis.
References
1) The official website of the National Medical Products Administration (NMPA) of China.
2) The official website of You'er Medicine.
*: Yakudo daily
Original: Jiang Li.