Shanghai Digital Medicine Intelligence and Ark Biopharmaceutical Announce Strategic Partnership to Accelerate Commercialization of ADHD Digital Therapeutics

On March 1, 2024, Shanghai Shuyao Intelligent Technology Co., Ltd. (hereinafter referred to as “SDODT”) and Shanghai Aike 100 Biomedical Technology Co., Ltd. (hereinafter referred to as “ArkBio”) signed a comprehensive strategic cooperation agreement to jointly promote combination therapy regimens integrating conventional pharmaceuticals with innovative digital therapeutics for Attention-Deficit/Hyperactivity Disorder (ADHD), thereby addressing the emerging clinical needs for “treatment-plus” approaches in ADHD management.

Li Wenyu, CEO of SDODT; Zhou Chen, Chief Business Officer of SDODT; Hu Xin, Assistant to the Chairman of Century Huatong; Dr. Wu Zheng, Chairman and CEO of ArkBio; Zhang Daoyuan, Chief Business Officer of ArkBio; and other executives and accompanying personnel attended the signing ceremony to jointly witness this significant moment.

Signing in progress

In 2020, after Century Huatong officially entered the field of brain science research, SDODT, an ecosystem enterprise under its subsidiary Shengqu Games focused on digital therapeutics R&D, was established. The company independently developed ZhuanShuDa, a product designed for the treatment of children aged 6–12 with ADHD.^®"Attention Enhancement Training Software," approved as a Class II medical device in 2023, is the first digital therapeutic approved in China for the treatment of ADHD.

How to effectively promote and popularize digital therapeutics, ensuring that they truly benefit children with ADHD and their families, remains a challenging hurdle that the entire innovative digital drug industry in China will need time to overcome. As a pioneer in digital medicines, SDODT has joined forces with ArkBio, an innovative biopharmaceutical company focused on pediatrics, to deeply integrate into China’s pharmaceutical system and accelerate the promotion and adoption of digital therapeutics, thereby benefiting more children with ADHD and their families. ArkBio specializes in the pediatric field, and its pipeline includes AZSTARYS, a new ADHD medication already approved by the FDA.^®(Aizhida^®), ArkBio currently holds the development and marketing rights for the Greater China region in clinical trials conducted in China.

Li Wenyu, CEO of SDODT, stated: “Helping patients alleviate their suffering is the original aspiration of every healthcare enterprise. The conclusion of this partnership, on one hand, allows our ‘digital prescription drug’ Zhuanshuda, which we have been diligently developing for many years,”^®We have taken a significant step closer to patients. We hope that both parties will fully leverage their respective resource advantages to jointly promote the development of ADHD diagnosis and treatment in China. On the other hand, as “veterans” in the gaming industry, we are proud to contribute to the socially responsible endeavor of empowering healthcare through gaming. Through continuous trial and error, overcoming challenges, and collaborative integration, we have truly achieved meaningful “innovation.”

SDODT CEO Li Wenyu

In China, the overall prevalence of ADHD among children and adolescents is as high as 6%.^[1-2], with over 23 million children and adolescents currently living with ADHD. Survey data indicate that more than 60% of parents of children with ADHD are dissatisfied with current pharmacological treatment regimensMaintain a reserved attitude^[3]. This comprehensive strategic partnership between SDODT and ArkBio will fully leverage their respective technological and resource advantages to foster in-depth collaboration in the diagnosis and treatment of ADHD in children and adolescents, thereby providing next-generation digital therapeutic solutions to more medical institutions and patients.

Dr. Wu Zheng, Chairman and CEO of ArkBio, stated: "ArkBio has always been committed to the research and development of innovative drugs to address unmet medical needs. In the field of ADHD treatment for children and adolescents, the company previously introduced Aizhida, the latest generation of ADHD therapeutics that offers extended duration of action and prevents drug abuse."^®. This collaboration with SDODT aims to promote Zhuanshuda, China’s first approved digital therapeutic for ADHD^®, providing therapeutic solutions that combine innovative drugs with digital therapeutics, while also supporting ArkBio in further deepening its strategic layout in this field. Through innovative integration and collaborative win-win efforts, we are confident that this partnership will meet diverse clinical needs and benefit more children with ADHD and their families!

Dr. Wu Zheng, Chairman and CEO of ArkBio

ZhuanShuDa^®Clinical trials conducted in collaboration with authoritative domestic children's hospitals showed that after one month of use, pediatric patientsAttention function improved by 68%, symptoms alleviated by 73%, with significant efficacy。Meanwhile, Zhuanshuda^®Suitable for home-based treatment with low compliance difficulty and high adherence. The collaboration between the two parties will provide superior diagnosis and treatment solutions for ADHD patients in China,Jointly promote the diagnosis and treatment model in China that combines traditional ADHD medications with innovative digital therapeutics,It also paves a distinctive path for the commercialization of China’s digital therapeutics industry, tailored to the country’s unique context.

January 2024: SDODT's Zhuan Shuda^®The true commencement of commercial implementation has been marked by the initial product deliveries to Sinopharm Holding Guangzhou Co., Ltd. and Shanghai Pharma Cardinal Health Luoda (Shanghai) Pharmaceutical Co., Ltd., basically achieving comprehensive coverage across China’s healthcare system. As promotion deepens, hospitals in provinces and municipalities nationwide have successively begun issuing prescriptions, enabling patients to receive professional diagnostic and therapeutic services within familiar medical environments.

SDODT, established in 2021, is an innovative digital therapeutics technology company centered on independent research and development, and a member of the Century Huatong ecosystem. By integrating biosensing applications with artificial intelligence analysis and leveraging cutting-edge neural network research, SDODT is committed to providing digital therapeutic solutions for the diagnosis and treatment of neurological disorders, thereby advancing the development of digital precision medicine and promoting frontier research in neuroscience. Upholding a spirit of proactive innovation and determination, the company focuses on clinical needs and relies on EEG biosignal technology and core algorithmic analysis to develop technologies, products, and platforms for digital therapeutics, creating efficient, convenient, and universally accessible digital therapeutic solutions. SDODT has assembled a team of outstanding multidisciplinary experts and has completed the development of its specialized digital therapeutic solution for Attention-Deficit/Hyperactivity Disorder (ADHD).^®“Attention Enhancement Training Software,” the AI Galaxy Cognitive Training System for Autism Spectrum Disorder (ASD), and the brain-computer interface product “ShuMian” are among a matrix of digital therapeutics products that have laid a solid foundation for the broader application of digital medical technologies.

ArkBio is an innovative biopharmaceutical company focused on addressing significant unmet clinical needs in the fields of pediatric and respiratory diseases. Since its establishment in 2014, the company has developed multiple core technologies and global patents in the research and development of innovative drugs with novel mechanisms of action. By combining independent R&D with external licensing, ArkBio has built a highly differentiated and robust product pipeline. Its core product, Aisiwei^®It is the first RSV-specific antiviral drug globally to complete Phase III clinical trials with positive results, and also the first non-oncology new drug included in the National Breakthrough Therapy Designation. Another product nearing commercialization is AZSTARYS, a new drug for attention-deficit/hyperactivity disorder (ADHD) that has received FDA approval.^®(Chinese name: Aizhida^®), ArkBio holds the development and marketing rights for the Greater China region. The company also has several new drug candidates with best-in-class or first-in-class potential currently in clinical trials or preclinical development.

References

[1] Wolraich ML, Hagan JF Jr, Allan C, et al. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit /hyperactivity disorder in children and adolescents[J]. Pediatrics, 2019, 144(4):

e20192528. DOI: 10.1542/peds.2019-2528.

[2] Wang T, Liu K, Li Z, et al. Prevalence of attention deficit /

hyperactivity disorder among children and adolescents in China: a systematic review and meta-analysis(J). BMC Psychiatry, 2017,17(1):32. DOI:10.1186/12888-016-1187-9.

[3] Huang Chunjuan, Zhang Jie, Qi Weili, et al. Awareness and Treatment Attitudes of Parents of Children with Attention-Deficit/Hyperactivity Disorder [J]. Chinese Mental Health Journal, 2012, 26(10): 766-770.