Today (June 16th), Shanghai Aike Baifa Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as "Aike Baifa") announced that its new drug Aizhida (generic name: Sildenafil/Dexmedetomidine Compound Capsules; code: AK0901) has been officially accepted by the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) of China, and has been included in the "priority review and approval" procedure. The proposed indication is the treatment of attention deficit hyperactivity disorder (ADHD) patients aged 6 years and above.

Attention Deficit Hyperactivity Disorder (ADHD), commonly known as ADHD, is a chronic brain disease characterized by difficulty concentrating, hyperactivity, and impulsivity. ADHD symptoms may begin to appear in children between the ages of 3-6 and can persist into adolescence and adulthood. ADHD is the most common mental illness in childhood, affecting 8% to 9% of school-age children.

Methylpheniramate has been recommended as a first-line treatment option for children and adults with ADHD in multiple guidelines and consensus for many years. Since its launch in 2000, it has become a widely used drug in clinical practice. AK0901 is a compound formulation containing immediate release methylphenidate (d-MPH) and prodrug methylphenidate (SDX). It is an innovative therapeutic drug for attention deficit hyperactivity disorder and was approved for sale in the United States in March 2021. It is the first methylphenidate drug approved by the FDA in nearly 20 years.

According to a press release from Aike Baifa, AK0901, as a third-generation methylphenidate drug, has an innovative compound formulation design that directly targets the clinical pain points of ADHD treatment, with both rapid onset and long-term control. For pediatric patients, AK0901 can help them better concentrate, improve academic performance, and enhance social skills in both learning and daily life; For adult patients, it helps to improve work efficiency, enhance interpersonal relationships, and improve quality of life.