Ark Biopharmaceutical has announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Azstarys, an extended-release capsule therapy for Attention-Deficit/Hyperactivity Disorder (ADHD).

Ark生物制药公司宣布，中国国家药品监督管理局（NMPA）已接受其针对注意力缺陷/多动障碍（ADHD）的缓释胶囊疗法Azstarys的新药申请（NDA）。

Azstarys includes an in-built abuse-deterrent feature due to its slow-converting SDX component, which helps to reduce peak plasma levels and potential misuse through non-oral methods an important consideration in ADHD treatment.

由于其缓释型SDX成分，Azstarys具有内置的防滥用特性，这有助于降低血浆峰值水平，并减少通过非口服方式滥用的可能性，这是在ADHD治疗中需要重点考虑的因素。

Azstarys (AK0901) is the first methylphenidate combination drug of its kind approved globally. It combines immediate-release dexmethylphenidate (d-MPH) with serdexmethylphenidate (SDX), a prodrug that provides sustained release. First approved by the U.S. FDA in 2021, the drug offers a dual-phase release system designed to deliver both rapid symptom relief and extended control throughout the day..

Azstarys (AK0901) 是全球首个获批的甲基苯丙胺组合药物。它将速释型右旋甲基苯丙胺 (d-MPH) 与前药Serdex甲基苯丙胺 (SDX) 结合，后者提供持续释放。该药物于2021年首次获得美国FDA批准，采用双相释放系统，旨在提供快速的症状缓解以及全天的持续控制。

The application has also been granted Priority Review status.

该申请还被授予了优先审查状态。

The pharmacokinetic profile of Azstarys supports symptom management for up to 13 hours. Its fast-acting d-MPH component starts working within 30 minutes, while the SDX component gradually converts to d-MPH in the intestine, helping to reduce evening rebound symptoms and improve daily functioning for both children and adults.

Azstarys 的药代动力学特征支持长达 13 小时的症状管理。其速效的 d-MPH 成分在 30 分钟内开始起效，而 SDX 成分在肠道中逐渐转化为 d-MPH，有助于减少晚间的反弹症状，并改善儿童和成人的日常功能。

The formulation is also designed to minimise sleep disturbances..

该配方还旨在尽量减少睡眠干扰。

In a Phase III clinical trial conducted across eight hospitals in China, the drug showed significant improvements over placebo across primary and secondary efficacy measures. No drug-related serious adverse events were reported, reinforcing its safety and tolerability, particularly in children.

在中国八个医院开展的 III 期临床试验中，该药物在主要和次要疗效指标上均显示出显著优于安慰剂的效果。未报告与药物相关的严重不良事件，进一步证明了其安全性和耐受性，尤其是在儿童群体中。

Its introduction is expected to enhance treatment options by offering a single-dose solution with both immediate and long-lasting effects.

预计其引入将通过提供具有即时和持久效果的单剂量解决方案来增强治疗选择。

Azstarys is positioned as a third-generation methylphenidate treatment and, if approved, will be the first combination therapy for ADHD to enter the Chinese market.

Azstarys被定位为第三代哌甲酯治疗药物，如果获得批准，将成为进入中国市场的首个ADHD联合疗法。

Source: arkbiosciences.com

来源：arkbiosciences.com