At the start of the new year, biomedical companies in Shanghai's Pudong New Area have successively announced their latest progress. Pudong is speeding up the development of new drugs from the lab to trials.

ArkBio, a pharmaceutical company based in Pudong, revealed that its core product Azhida (AK0901) was recently approved in China for attention deficit hyperactivity disorder (ADHD) and has now entered the commercial launch phase.

By integrating immediate-release and long-acting prodrug technologies, AK0901 has the potential to become the first ADHD medication in China to offer both rapid onset and sustained symptom control.

Two innovative drugs have been approved to enter clinical trials. ReviR Therapeutics, an XtalPi-incubated company, has received approval from the National Medical Products Administration to initiate Phase I clinical trials for its small-molecule candidate RTX-117 in the first quarter of 2026 for the treatment of Charcot-Marie-Tooth (CMT) disease.

XtalPi's laboratory in Pudong New Area, Shanghai. [Photo/WeChat ID: pdnews]

As China's first Class 1 innovative drug for CMT disease to enter clinical development, RTX-117 represents a breakthrough in CMT therapeutics. Designed as a targeted treatment, it has the potential to intervene at an early stage of the disease, significantly reducing or even preventing the onset and progression of disability.

In addition, NeuShen Therapeutics' M4 receptor positive allosteric modulator (M4 PAM) NS-136 has received clearance from the United States Food and Drug Administration (FDA) to initiate a Phase II clinical trial for the treatment of agitation in Alzheimer's disease (AAD).

Receiving its first clinical trial clearance in the US, the company has achieved a key milestone in its global pipeline strategy as it makes another step forward in the international multicenter development of NS-136.

The Phase II trial is designed to evaluate the efficacy and safety of NS-136 in treating AAD. Meanwhile, NeuShen Therapeutics has applied to conduct a Phase II clinical trial for AAD in China.