Shanghai Shuyao Intelligence Submits IPO Prospectus Following Approval of China's First ADHD Digital Therapeutic

In recent days, Shuyao Intelligence has leveraged nearly two years of intensive development to successfully complete a multi-center GCP clinical trial for its “Attention Reinforcement Training Software.” Clinical outcomes have validated the software’s efficacy, compliance, and safety in children with ADHD following a one-month attention reinforcement training intervention. The product has currently obtained a Class II Medical Device Registration Certificate from the National Medical Products Administration (Registration No.: Xiang Xie Zhu Zhun 20232210315). According to Shuyao Intelligence,This is a Class II medical device certification for Attention-Deficit/Hyperactivity Disorder (ADHD). The “Attention Enhancement Training Software” is also among the first “digital therapeutics” in this field, suitable for adjunctive treatment and rehabilitation training for children with ADHD (aged 6–12), filling the gap in China’s digital therapeutics sector for ADHD.

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ShuYao Intelligence’s “Attention Enhancement Training Software” has achieved phased breakthroughs and made new progress in regulatory approval, which will accelerate the company’s research and development of brain science-based digital therapeutics technologies and products. As a supplement to and optimization of traditional therapies, digital therapeutics will provide new treatment options for over 20 million ADHD patients in China, shedding new light on ADHD rehabilitation.

In China, the overall prevalence of ADHD among children and adolescents is as high as 6%, with more than 23 million children and adolescents currently affected by ADHD.

This population segment demonstrates strong payment capacity, high willingness to pay, and benefits from substantial policy support, making it an emerging multi-billion-dollar market that has attracted significant interest and strategic positioning from numerous investors. According to Shuyao Intelligence, its ADHD digital therapeutic product, "Attention Enhancement Training Software," meticulously developed over two years, boasts significant technological and clinical barriers. Having undergone rigorous clinical evaluation and market validation, the product has achieved remarkable user acclaim and clinical efficacy.

In the registration clinical trials conducted in collaboration with the Children's Hospital of Zhejiang University School of Medicine and Hangzhou First People's Hospital, Director Jiang Kewen (Director of the Department of Psychology at the Children's Hospital of Zhejiang University) and Director Jiang Chunming (Director of the Department of Pediatrics at Hangzhou First People's Hospital) highly affirmed the product. From the perspective of patient usage, the product demonstrated high compliance, enabling patients to complete the 28-day home-based intervention training consistently. Furthermore, it offered greater engagement compared to traditional intervention methods, resulting in higher patient acceptance. In terms of clinical efficacy, after adhering to the 28-day intervention, patients showed significant improvement in attention, with no product-related adverse reactions observed, indicating a high safety profile. Regarding clinical needs, this novel intervention approach can help bridge the gap during periods when pharmacological treatment is not administered, providing additional intervention options for children with ADHD and reducing the time burden on parents associated with hospital visits.

Currently, most children with ADHD are treated with traditional pharmacotherapy. On one hand, since these medications are largely central nervous system stimulants or inhibitors, they carry certain side effects, leading to low acceptance among parents. On the other hand, although these drugs take effect rapidly, patient adherence is poor. For most conditions, medication is typically required for only one to two weeks; however, ADHD medications often need to be taken continuously for six months or even longer, making long-term adherence challenging for children.

Children are naturally inclined toward interaction. For children with ADHD, in particular, a guiding approach is far more effective than suppression. However, traditional manual interventions often suffer from low efficiency, making them well-suited for replacement by game-based approaches integrated with evidence-based medical knowledge. Shuyao Intelligence leverages functional games as a medium, employing its unique digitally constructed interactive methods to enhance children’s attention, memory, and other cognitive functions. This approach breaks through temporal and spatial constraints, boosts patient engagement and adherence, and ultimately improves therapeutic outcomes.

 Shuyao Intelligence’s ADHD Digital Therapeutic Product—“Attention Enhancement Training Software”

Regarding the specific intervention protocol, Shuyao Intelligence’s digital therapeutic product for ADHD, titled “Attention Enhancement Training Software,” features a 28-day intervention cycle. Users are required to complete five sessions per week, with each session involving at least 25 minutes of level-based training. Throughout the intervention, user performance is monitored and tracked in real time via the backend system. The intervention plan is dynamically adjusted based on individual progress and intensity to maximize therapeutic efficacy while minimizing the risk of addiction.

"Attention Enhancement Training Software" Product Interface

Furthermore, the “Attention Enhancement Training Software” will achieve real-time integration with various brain-computer interfaces in the future. The synchronization rate of the treatment process and the EEG signal acquisition rate from patients will reach the millisecond level. By adopting a closed-loop training approach that integrates assessment with training, the system can accurately pinpoint the patient’s condition and provide timely and effective feedback throughout the training process.

In early 2020, the Shuyao Intelligence team began exploring the field of digital therapeutics. The FDA approval of overseas digital therapeutic products, in particular, accelerated the team’s progress on its ADHD digital therapy project. Starting in August 2020, leveraging the scientific and academic expertise of the “Zhejiang University Legend Innovation Research Center,” Shuyao Intelligence developed and launched its digital therapeutic product for treating pediatric ADHD, titled *Attention Enhancement Training Software*, which uses functional games as its medium, all within less than a year. After finalizing the product design, Shuyao Intelligence promptly initiated multicenter clinical trials.

Clinical trials were conducted in phases with the Children's Hospital of Zhejiang University School of Medicine starting in 2021, with the Children's Hospital of Fudan University in 2022, and with both the Children's Hospital of Zhejiang University School of Medicine and Hangzhou First People's Hospital from 2022 to 2023. Multiple investigator-initiated trials (IITs) and multi-center Good Clinical Practice (GCP) trials have been successfully completed. Participants who underwent a one-month intensive attention training program demonstrated improvements across various metrics.

Clinical trial results from multiple batches and multi-center studies demonstrate that treatment with the "Attention Enhancement Training Software" led to statistically significant improvements in both the ADHD-RS-IV scale scores (assessing core symptoms) and objective attention function test scores (TOVA API) in children with ADHD (p < 0.01 for the former, p < 0.001 for the latter). Statistically significant improvements (p < 0.05) were also observed across multiple sub-items of various ADHD symptom assessment scales, such as the Conners Parent Rating Scale, Weiss Functional Impairment Rating Scale, and Behavior Rating Inventory of Executive Function (BRIEF)-Parent Version. These clinical trial findings support the safety and efficacy of the "Attention Enhancement Training Software." The remarkable outcomes achieved are a testament to the considerable effort and dedication invested.

Li Wenyu, CEO of Shuyao Intelligence, stated: Since its inception, Shuyao Intelligence has alwaysPioneering the Era of Digital Therapeutics for Brain HealthGuided by its mission to explore and understand the human brain and help people improve their mental health, Shuyao Intelligence will accelerate product development and software-hardware upgrades for neurological and psychiatric conditions such as Parkinson’s disease, Alzheimer’s disease, depression, and sleep disorders in 2023. Meanwhile, it will speed up the development of an open brain-computer interface (BCI) platform to provide software platform support for more BCI products, which will not only facilitate the commercial deployment of more BCI devices but also significantly shorten their R&D cycles. Based on its understanding and judgment of building a digital therapeutics industry for neurological diseases in the medical field, Shuyao Intelligence firmly believes that digital therapeutics will become a third category of treatment alongside pharmaceuticals and medical devices in specific areas, generating substantial social and commercial value.The approval of the ADHD digital therapeutic product is just the beginning. Shuyao Intelligence will continue to focus on its products and technology, using clinical efficacy and user experience as benchmarks to steadily advance each step of commercialization.In the future, Shuyao Intelligence will accelerate the launch of more new products, boosting the development of digital therapeutics in China and helping more patients with brain disorders.

ShuYao Intelligence, established in 2021, is an innovative digital therapeutics company centered on independent research and development, and a member of the Century Huatong ecosystem. By integrating biosensor application research with artificial intelligence analysis, and leveraging cutting-edge advancements in neural network science, the company is dedicated to providing digital therapeutic solutions for the diagnosis and treatment of neurological disorders, thereby advancing the development of digital precision medicine. Meanwhile, it continuously explores effective applications of digital healthcare across various fields to promote frontier research in neuroscience.

The Company has always adhered to the spirit of proactive innovation and forging ahead, centering on clinical needs and leveraging EEG bioinformation technology and core algorithm analysis to develop technologies, products, and platforms for digital therapeutics, thereby pioneering efficient, convenient, and universally applicable digital therapeutic solutions. Meanwhile, Shuyao Intelligence is actively expanding into brain-computer interface (BCI)-related fields. By capitalizing on its advantages in neuroscience and its open software service platform for BCI, the Company fosters collaboration and translation of research outcomes between BCI research and applications, establishing a robust platform to facilitate integrated innovation and foundational cooperation across the industry chain.

ShuYao Intelligence has assembled a team of outstanding, multidisciplinary experts and has completed the development of a portfolio of digital therapeutics products, including the “Attention Enhancement Training Software” for Attention-Deficit/Hyperactivity Disorder (ADHD), the “Autism Rehabilitation Training Software” for Autism Spectrum Disorder (ASD), and the brain-computer interface product “ShuMian,” laying a solid foundation for the broader application of digital medical technologies.

In the future, Shuyao Intelligence will continue to strengthen its scientific research and technological development. By leveraging continuous innovation in technology and products, it aims to explore and understand the human brain, help improve mental health, serve society, and provide health safeguards for a better life for humanity.