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The First Digital Drug Approved by Nmpa in China: Zhikang App

Digital medicine is a new concept, which includes software or hardware based on clinical evidence. These products can be used to measure or intervene human health. Such as artificial intelligence diagnosis system, patient remote monitoring system, digital biomarker equipment, etc.

In 2017, the world's first digital drug was certified and licensed by the FDA (US Food and Drug Administration). Three years later, China's first digital drug, Zhikang app, was also approved by the nmpa (China National Drug Administration) for listing. As a prescription, it was directly issued by doctors for patients.

With the remote intelligent evaluation of cardiopulmonary / muscle and bone / nutrition as the core, combined with the scientific combination of wearable devices and prepackaged medical food, Shukang can be easily implemented at home and greatly reduce the implementation cost of "personalized exercise / nutrition intervention", which is less than 1 / 10 of the traditional way (outpatient Implementation).

Milestone of domestic digital medicine

In 2017, the world's first digital drug was approved by the US FDA. This drug places a sensor into each tablet, and doctors can monitor patients' medication according to the transmitted information. This product saves nearly $300 billion in losses caused by patients' failure to take medication on time in the US medical system.

Three years later, China's first "digital medicine" - Intelligent telemedicine product "Shukang app" with personalized lifestyle intervention was also approved to be listed after rigorous review.

For a long time, the overall development of domestic "digital medicine" track has been slow. In the past few years, it has been in the exploratory stage. With the improvement of medical level, the rapid development of mobile Internet industry and the application of 5g, the popularization of wearable devices and intelligent software, and the in-depth application of artificial intelligence to medical data, the development of digital medicine industry has significantly accelerated.

In 2015, after the full investigation of China's medical market and hospital rehabilitation, he started to focus on the whole process of rehabilitation for chronic diseases in the hospital and out of hospital, and realized the remote intelligent intervention of personalized lifestyle based on Internet technology, and achieved home rehabilitation easily, effectively reducing the incidence rate, admission rate and readmission rate.

Why was Zukang app approved as a "digital drug"?

Shangyi information technology, a subsidiary of Shukang, has been working closely with Baylor, one of the largest medical groups in the United States, and has been "cardiopulmonary muscle and bone" in Baylor for decades Based on the integrated overall rehabilitation practice, combined with the current situation of the vigorous development of domestic mobile Internet and wearable devices, a remote home rehabilitation treatment characterized by personalized fitt-vp sports rehabilitation system is developed by combining Shukang app with intelligent hardware.

Shu Kang is mainly used for rehabilitation of chronic diseases and chronic pain, such as hypertension, diabetes, heart failure, discharge, postoperative rehabilitation, etc. It can carry out remote intelligent evaluation, personalized exercise and nutrition prescription, video prescription follow-up training, remote video guidance, whole process data monitoring, intelligent quantitative follow-up and AI intelligent management according to the patient's specific condition and cardiopulmonary / musculoskeletal condition.

In remote intelligent assessment, patients need to complete comprehensive assessment, including questionnaire, cardiopulmonary endurance test and exercise ability test. According to the comprehensive assessment results, personalized exercise prescription including exercise type, exercise intensity, exercise duration and exercise frequency is obtained. Patients only need to wear intelligent hardware and follow the rehabilitation training video to complete the treatment process. During training, the system will Risk warning to remind patients that the data generated during exercise will be uploaded immediately, so that doctors can view the training progress and body data at any time in the background, intelligently adjust the exercise prescription, and doctors can also correct it.

In China, novel coronavirus pneumonia and new type of pneumonia were discharged from thirty hospitals in China, including 2 hospitals, including 11 patients, who were discharged from hospital in the past 2 years. The above three clinical trials were conducted in Nanjing, including the International Academy of Medical Sciences and Nanjing Medical Sciences. Professor Li Jianan, director of rehabilitation medicine center of the First Affiliated Hospital of University of science and technology, led the "remote monitoring exercise rehabilitation program for the treatment of New Coronavirus pneumonia discharged patients" project has achieved very significant results.

The population of chronic diseases is becoming larger and larger, and Shu Kang is the solution

As a "digital medicine" for remote home rehabilitation treatment, Shukang app will form a win-win situation for society, hospitals and patients: reducing medical costs, improving patient management efficiency, improving patient quality of life, etc.

In diabetes, the prevalence of diabetes in China is 9.7% to 11.6% and about 110 million in the diabetic population. WHO estimates that China's economic losses due to diabetes and related cardiovascular diseases in the 20052015 year are 557 billion 700 million US dollars.

APP can effectively control the blood glucose level of patients, and even achieve the effect of reversing. This is the result of clinical research on "the effect of remote monitoring exercise on the prognosis of patients with type 2 diabetes" jointly conducted by Shu Kang and West China Hospital of Sichuan University. The results of clinical research have proved that 27% of diabetic patients in APP group have reduced the dosage and 12% completely discontinued.

Effect of exercise on prognosis of patients with type 2 diabetes under remote monitoring: a clinical study

The clinical results show that Shukang app can effectively stabilize and reduce blood sugar, even let patients get rid of the trouble of lifelong medication, and greatly save medical expenses. With the intervention of Shukang, patients can gradually form a healthy lifestyle and improve the quality of life.

In addition, doctors can realize the online management and treatment of patients only through Shukang, complete the transformation from the traditional "1-to-1" to "1-to-many" management mode, improve the management efficiency by at least 10 times, and realize the "large-scale and low-cost" treatment.

Shu Kang is not just China's livongo

The US Livongo focused on the rehabilitation management of diabetic patients. It was founded in 2010 and went public in 2019. The market value of the listed companies exceeds US $3 billion. This year it merged with the US digital medical giant Teladoc, and the new company's valuation reached US $18 billion 500 million. They mainly implemented the management through the combination of hardware and software, and the rehabilitation department communicated with the patients every day through telephone or e-mail, to understand the situation. Waking up the other person to go to a medical institution for rehabilitation treatment is cumbersome and complex, and the number of patients managed by one person is very limited.

Shukang adopts AI Artificial Intelligence calculation, which can intelligently match personalized exercise prescriptions according to the comprehensive evaluation of patients and push them to patients through the review of doctors; the system will also calculate and analyze the patient's exercise data, intelligently optimize prescriptions, greatly reduce the workload of doctors and increase the number of manageable patients by dozens of times.

As Lei Zhen, CEO of Shangyi information technology, said: "we have built a perfect underlying medical logic of chronic diseases and chronic pain in three years, which can be well applied to Shukang. Combined with mobile Internet technology, a doctor can easily manage 100 patients with Shukang."

Highly recognized and entering the international market

In November 2019, the international version of Shukang app officially entered the U.S. market and was approved by the U.S. HCA company (the largest medical group in the United States) The novel coronavirus pneumonia and Baylor Medical Center for rehabilitation of patients with heart failure quickly reduced the readmission rate of heart failure patients from 30 to 2% in 2% days, and directly raised the effectiveness of a 6 rehabilitation team in Dallas to 200 patients. In the early stage of the outbreak of the new crown pneumonia in the United States, the doctor was also used by doctors in the treatment of new champions with mild and moderate patients.

The international version of Shukang app has attracted much attention from professionals in the United States. It is understood that Shukang has cooperated with HCA, Baylor and bluecross (Blue Cross Insurance Co., Ltd., one of the largest medical insurance companies in the United States) Cooperation: Dr. satjit bhusri, a famous cardiologist in the United States, and circle health, a famous Heart Health Organization in Texas, have determined to cooperate with Shukang, and decided to close their own heart health center and use the international version of Shukang app to guide the home rehabilitation of all patients.

As the first digital drug approved by nmpa in China, Shukang app not only fills the gap of digital drugs in China, but also injects a shot in the arm for the development of the industry.

China's digital drugs can be expected in the future.

The First Digital Drug Approved by Nmpa in China: Zhikang App 1

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