ShuKang Digital Therapeutics System: Broad Indication Coverage, Full-Cycle Care, and High Clinical Efficacy
Since the beginning of 2022, a number of star international digital therapeutics companies—Pear Therapeutics, Akili Interactive, Hinge Health, Noom Health, and Better Therapeutics—have successively announced news that they have completed or are about to complete their initial public offerings (IPOs).
In contrast, within the domestic market, although digital therapeutics firmly held the top position among emerging innovative healthcare segments in 2021, validating the innovative value of products and establishing appropriate business models remain the most urgent challenges for digital therapeutics companies. Nevertheless, this cannot halt the momentum of digital therapeutics development. As the general trend dictates, the pioneers will prevail.
After years of research and development and clinical studies, the “Shukang” APP, independently developed by Chengdu Shangyi Information Technology Co., Ltd. (hereinafter referred to by its brand name “Shukang”), was approved by the National Medical Products Administration (NMPA) in November 2020, becoming a pioneer in “digital therapeutics.” The international version of “Shukang” has been adopted as a first-line treatment modality in authoritative hospitals in the United States and obtained EU CE certification in October 2021.
As the world’s first digital therapeutic software for exercise prescription, ShuKang has continuously achieved “First in China” milestones in digital therapeutics over the past seven years, steadily strengthening its “professional moat.”
According to the classification in the "White Paper on Digital Therapeutics in China 2.0," digital therapeutics can be categorized into eight major types based on primary indications: respiratory diseases, nervous system diseases, endocrine, nutritional, and metabolic disorders, circulatory system diseases, mental, behavioral, and cognitive disorders, ophthalmic diseases, oncological diseases, and other diseases.
Currently, international digital therapeutics (DTx) stars such as Akili Interactive and Hinge Health are almost exclusively focused on developing products for a single primary indication, leaving them largely ineffective against chronic diseases in their middle to late stages that involve multiple comorbidities. In contrast, the three major DTx modules within Shukang’s “Digital Therapeutic System”—cardiopulmonary and musculoskeletal exercise therapy, cognitive training, and nutritional therapy—can cover seven major disease categories, excluding ophthalmic conditions.
Based on existing evidence-based medical data, Shukang integrates traditional exercise testing, fundamental principles of exercise prescription, and video-guided exercise rehabilitation into a smartphone application. Coupled with smart wearable devices, the Shukang APP enables remote home-based exercise therapy for patients and remote exercise guidance for physicians.
As the world’s first digital therapeutic software for exercise prescription, the Shukang APP focuses on enhancing cardiorespiratory fitness to conduct exercise assessment and treatment for chronic diseases. It is applicable to the treatment and prevention of nearly all chronic conditions associated with declined cardiorespiratory fitness, covering at least 26 types of chronic diseases, including common endocrine and metabolic disorders, cardiovascular diseases, cancers, and certain respiratory diseases. These conditions include hypertension, diabetes, hyperuricemia, metabolic syndrome, chronic heart failure, coronary artery disease, atrial fibrillation, colorectal cancer, breast cancer, chronic obstructive pulmonary disease (COPD), as well as post-discharge intervention for patients recovering from COVID-19.
Taking atrial fibrillation as an example, patients may experience significant discomfort in the short term after surgery, with marked declines in cardiopulmonary function and exercise tolerance. Home-based exercise therapy is a targeted treatment approach. However, due to current limitations, exercise therapy can only be delivered through one-on-one guidance by healthcare professionals within hospital settings. The substantial physical exertion, financial burden, and time costs associated with traveling to and from the hospital often lead patients to discontinue rehabilitation once their condition shows slight improvement. Such patient attrition significantly undermines treatment efficacy.
The Shukang APP provides remote intelligent assessments tailored to patients’ specific conditions and health status, personalized exercise programs, video-guided training based on exercise prescriptions, remote training guidance, comprehensive data monitoring, and intelligent quantitative follow-up. Unconstrained by time and space, it reduces patients’ healthcare costs, significantly improves patient adherence, facilitates physicians’ supervision of exercise prescription implementation, extends the scope of medical management, and enhances the accessibility of healthcare services.
In fact, the development and application experience of the Shukang APP has thus become the cornerstone of Shukang’s entire digital therapeutics system.As the first digital therapeutic product from Shukang, the underlying development logic of the Shukang App can be viewed as a template, enabling technological accumulation to begin with this product and expand outward—It has given rise to two major segments—“Nutritional Science” and “Cognitive Training”—along with numerous pipelines.
In 2018, Shukang Intelligent Nutritional Science began to exert its efforts, achieving a full-process workflow of “screening–assessment–nutritional therapy,” which not only reduced the workload of medical personnel but also enabled early detection and early treatment of diseases. Its exclusive patented“R+ Shukang Intelligent Nutritionist”Nearly 10 nutrition-related clinical studies have been conducted at Sichuan Provincial People’s Hospital, West China Hospital of Sichuan University, and West China Second University Hospital of Sichuan University. The application for Class II medical device certification is currently underway.
“ShuKang Cognitive Training”This division comprises international experts in brain development, neurologists, and a top-tier IT team. Currently, the cognitive training products developed by Shukang primarily target the treatment of conditions such as childhood ADHD and the enhancement of brain function, with future R&D efforts directed toward diseases characterized by cognitive decline. At present, Shukang has launched research under the “Educational Scientific Research Cooperation Program” in primary schools in Chengdu, while clinical research on the “Digital Diagnosis and Treatment of Children’s Brain Function,” conducted jointly with the Children’s Hospital of Henan Province, is also underway.
The prior successful approval of the Shukang APP by the NMPA provides reason to believe that RECOVERY PLUS’s accumulated R&D, clinical, and regulatory approval experience can be rapidly replicated across new pipelines, thereby avoiding many detours.
Unlike other chronic disease management software on the market, the Shukang APP can provide exercise therapy services to patients as an exercise prescription, with independent therapeutic efficacy.
Unlike traditional drugs, whose chemical structures and pharmacokinetic properties remain essentially unchanged after successful development, digital therapeutics offer treatment regimens that are continuously “upgraded, iterated, and evolved” based on big data and algorithms. This approach can lead to better patient prognoses, with its most disruptive value manifested in enhanced therapeutic efficacy.
Taking diabetes as an example, there are 463 million patients with diabetes worldwide and 116 million in China. However, the limited number of healthcare professionals cannot provide full-process intervention for self-management to all patients. Even with sufficient medical resources, manual intervention still faces issues such as high costs and low efficiency.
In the clinical study titled “Impact of Exercise Under Remote Monitoring on Patients with Type 2 Diabetes,” conducted by Shukang in collaboration with West China Hospital of Sichuan University, volunteer patients used the Shukang APP paired with heart rate monitors for supervised exercise over a three-month period. The rate of medication discontinuation and dosage reduction reached 30%, with four patients discontinuing medication entirely and nine patients reducing their dosage.
In the conventional exercise group, the rate of medication discontinuation and dose reduction was only 7.1%, with one participant discontinuing medication, two reducing their dosage, and five even increasing their dosage. The overall rate of medication discontinuation and dose reduction in the APP group was 4.2 times that of the conventional group, and the mean reductions in glycated hemoglobin (HbA1c) and body fat percentage were both greater in the APP group than in the conventional group.
This means that the Shukang App not only effectively stabilizes and lowers blood glucose levels but also significantly reduces medical expenses, establishing a service delivery model characterized by low cost, high efficiency, and broad coverage. As a prescription digital therapeutic product, the Shukang App supports exercise therapy for patients both within hospital settings and in remote, home-based scenarios outside the hospital, thereby achieving a true “extension of diagnosis and treatment across time and space.”
Furthermore, as the COVID-19 pandemic swept across the globe, the emergence of Shukang has allowed us to welcome with delight the arrival of Chinese digital therapeutics solutions in both domestic and international markets.
Since the outbreak of the pandemic in 2019, U.S. medical teams have urgently deployed the Shukang APP to enhance cardiorespiratory endurance and facilitate the recovery of cardiopulmonary function in patients with mild-to-moderate COVID-19 as well as in discharged COVID-19 patients, achieving significant therapeutic outcomes.
In April 2020, Professor Li Jian’an, a pioneer in rehabilitation medicine in China, spearheaded a clinical study titled “Impact of Exercise Under Remote Monitoring on Patients Discharged After COVID-19.” Shukang was the sole therapeutic software utilized in this study. Enrolled patients discharged after COVID-19 were divided into two groups: a conventional exercise group and an app-based intervention group. The intervention group received remote home-based exercise therapy, monitoring, and follow-up using the Shukang APP along with heart rate monitors, while the conventional exercise group performed self-directed exercises based on general exercise guidance.
The study results showed that, compared with the conventional exercise group, the APP intervention group achieved an average 6-minute walk distance of 588.4 meters—a metric reflecting cardiopulmonary function—approaching the average level of 624 meters observed in healthy individuals of the same age, representing a 15% improvement with significant therapeutic effects. The average static pulmonary function test scores increased by 5.79% in the APP intervention group, whereas the conventional exercise group experienced a 0.09% decline instead of an improvement. Additionally, lower-limb muscle endurance improved by an average of 90% in the APP intervention group, compared to only a 22.2% improvement in the conventional exercise group. These findings demonstrate that the efficacy of Shukang Digital Therapeutics exceeded expectations.
Over the years, Shukang has conducted up to 40 clinical studies on exercise therapy and nutrition in collaboration with more than 30 Grade A tertiary hospitals across China, including the Chinese PLA General Hospital and West China Hospital of Sichuan University. These studies have been applied to exercise rehabilitation research for stable coronary heart disease, post-PCI care, type 2 diabetes, obesity, chronic knee osteoarthritis, diabetes, gout, and hyperuricemia.
Shukang APP has not only demonstrated significant efficacy in clinical studies, but its real-world value has also been validated. In November 2019, the international version of Shukang APP entered the U.S. market and was subsequently adopted by HCA Healthcare, one of the largest healthcare groups in the United States, and Baylor Medical Center for cardiac rehabilitation in heart failure patients, reducing the 30-day readmission rate from 17.8% to 2.1%. In November 2020, more than 4,000 heart failure patients under the care of Dr. Satjit Bhusri, a renowned cardiologist in New York, began using the international version of Shukang APP for home-based rehabilitation.
Commercial health insurance is the mainstay of the U.S. healthcare system, and the Shukang app has partnered with Blue Cross, one of America’s health insurance companies.Furthermore, the Shukang App has also been included in the covered treatment insurance payer lists of major U.S. healthcare institutions such as Baylor Medical Center and HCA.. This indicates that the Shukang APP has gained recognition from mainstream U.S. healthcare institutions and insurance companies.
The Shukang APP fully leverages remote home-based exercise therapy management, not only helping patients save time and financial costs while improving adherence, but also enabling physicians to transition from the traditional “one-on-one” model to a “one-to-many” approach. This increases management efficiency by more than tenfold, effectively conserving human resources and reducing medical costs. It is reported that RECOVERY PLUS has already partnered with additional top-tier U.S. medical institutions to conduct clinical studies on remote home-based exercise therapy using the Shukang APP, while FDA submission and certification processes are currently underway.
The United States is undoubtedly the fastest-growing market for digital therapeutics, while China offers the greatest growth potential.Across the global digital therapeutics industry, only a handful of companies have established a presence in both the Chinese and U.S. markets. The Shukang APP has taken the lead by securing certification from China’s National Medical Products Administration (NMPA) and CE marking from the European Union, while also achieving pioneering commercialization in the United States. These milestones represent significant competitive advantages for RECOVERY PLUS.
On the long-distance track of digital therapeutics, Shukang is advancing the development and implementation of its digital therapeutic products at sprinting speed.