In the mid-19th century, California set off a "gold rush". Workers, farmers, seafarers and missionaries, former servants and successors, came to pan for gold. But there are also people who have found their own way and started to sell horses, punch boats, sell alcohol, and sell water for a living. Later, these people were collectively referred to as "water sellers". The essence of the theory of selling water is to meet the new needs of industries that have formed scale or will form in the future in a way that serves others. As long as there is a pair of eyes that are good at discovery, all walks of life have a "water seller" role.
As the first transformation of digital medicine to serious medical treatment, digital therapy has competed with start-ups, and enterprises in the fields of pharmaceutical equipment, wearables, games, Internet medical treatment, artificial intelligence, and mental health have collectively exerted their strength, and digital therapy has been hot for a time.
However, looking at China, it is not clear who can really become the leader among the current digital therapy companies. But what is certain is that the core value of digital therapy lies in serious medical treatment, and evidence-based medically validated digital therapy products are the cornerstone of all commercial possibilities.
The whole process of digital therapy from medical program design, product research and development, registration and declaration, clinical trials to market operation, and real-world research is interlinked. A problem in any one link can have a significant impact on digital therapy for enterprises.
However, there is still a huge gap in the professional control of the whole process from research and development to market access. As the saying goes, if someone "pans for gold", someone needs to "sell water". This invisibly brings an opportunity to revaluate the value of Zhilan Health, the vanguard of digital therapy certification.
Open the digital therapy CDMO imagination space
Prescription digital therapy is essentially the same as traditional medicine and devices, emphasizing that evidence-based medicine needs to be subject to strict approval and supervision, and it is necessary to ensure its clinical safety and effectiveness. However, digital therapy is an innovative ecological field, which has not yet had a unified clinical trial industry standard, and most of its clinical trials are currently in a state of crossing the river.
Gao Yunlong, general manager of Zhilan Health, said: "Unlike traditional drug targets (causes), digital therapy targets are more data-definable appearance characteristics (fruits). The underlying logic of digital therapy product development is digital technology based on medical principles and knowledge graphs. ”
For Internet medical enterprises that have focused on the connection of medical resources in the past, the construction of relevant medical capabilities is often lacking. In addition, digital therapy is data-driven and highly dependent on digital technology, while traditional medical companies lack corresponding experience in digital integration.
As the saying goes, professional things need to be left to professional people. And here, the first thing that comes to mind may be pharmaceutical CDMO and medical device CRO. However, in Gao Yunlong's view, digital therapy, as an emerging disease treatment method in addition to drugs and medical devices, needs its own CDMO services.
First of all, pharmaceutical CDMO enterprises use their own technical advantages and production capacity to undertake the process development and production functions of pharmaceutical companies, so that pharmaceutical companies can focus more on drug research and development. The current situation of digital therapy is that many companies only have product ideas or prototypes, and do not know how to do medical program design, clinical trials and even registration declarations, nor do they understand the evidence-based medical logic that needs to be implemented between various links.
However, medical device CRO companies often only begin to intervene when the product enters the certification stage, provided that the digital therapy company already has a product form, and the product basically meets the regulatory needs. According to Gao Yunlong, in fact, many pharmaceutical equipment, wearable, Internet medical and game companies that have transformed to digital therapy are precisely the medical solutions, product design and research and development links before the certification are relatively weak, and medical device CRO companies often can't help.
Zhilan Health Digital Therapy CDMO and Full Process Service Source: Enterprise official website
"There are essential differences in the role and positioning of digital therapy CDMO and traditional biomedical CDMO or instrument CRO, digital therapy CDMO is not a simple service outsourcer, but a deep partner of enterprises, and the two sides can link wider resources based on CDMO cooperation and explore the possibility of more ecological cooperation." Gao Yunlong explained the difference.
In addition, "the scope of application of digital therapy products depends on the disease intervention method and target accessibility, and there is no limit to the type of indications." In general, diseases with long-term management, more interventions, clear clinical guidelines, lower levels of patient compliance and self-management are more suitable for the development of digital therapy products. In fact, many diseases often do not develop a single disease in the end, and most of them are accompanied by multiple complications, but the development of many digital therapies does not fully take into account the comprehensive treatment situation. ”
Therefore, Zhilan Health Choice, one of the first batch of certified enterprises in digital therapy, will replicate its experience and capabilities, create a larger digital therapy CDMO and full-process service platform, give comprehensive evaluation and overall medical design solutions for specific indications, and make a ladder to help more digital therapy products succeed.
Medicine + market access capabilities lean in
Be a "water seller" on a 10-billion-dollar track
According to Insight Partners statistics, the global digital therapy market size is expected to grow from $4.22 billion in 2021 to $18.06 billion in 2028, with a compound annual growth rate (CAGR) of 23.1%, and the vast market has attracted a large number of companies in the fields of games, medical devices, biomedicine, and smart devices.
However, objectively speaking, the development of digital therapy is still in the early stage of history, and there are still many constraints before large-scale commercial application. For example, digital therapy is a good entry point for smart device companies that want to enter the medical field, they have advanced equipment and a large user base, but they are outside of serious medical treatment, and medical capabilities and medical resources are quite limited.
Pharmaceutical companies also cannot rely solely on the acquisition of digital therapy companies to fill their businesses, because they will face the risk of integration and the problem of reaching a single resource. The digital therapy CDMO enterprise is a "customization + platform" attribute, which can customize and develop products for the needs of the enterprise itself, and the corresponding channels and medical resources behind it are more diverse.
Founded in 2015, Zhilan Health provides digital therapy CDMO and full-process services that are deeply connected through the entire industry chain from digital therapy research and development to real-world research. As a deep practitioner in the field of digital therapy for many years, Zhilan Health has accumulated profound advantages and successful experience in digital therapy medical solution design, product development, functional polishing and efficacy verification.
In terms of medical capacity construction, Zhilan Health has the top clinical research resources in China. More than 65% of the team have medical backgrounds and medical industry experience. From product establishment to real-world research at all stages, Zhilan Health has a dedicated medical and engineering complex team to lead the design of evidence-based medical solutions, clinical research design, post-market operation and maintenance, and real-world data verification to ensure the science, safety and effectiveness of all aspects of digital therapy products.
In addition, Zhilan Health has brought together more than 10 major cooperative experts and academicians of digital therapy projects in different product pipelines, more than 2,300 digital therapy medical expert resources, and more than 600,000 patients have been managed, with rich experience in life cycle services. Its self-developed hepatitis B maternal and infant blockade auxiliary management software has completed the second phase of real-world research, with a total of nearly 40,000 sets of data governance work, which is the largest real-world research case in the field of digital therapy.
Zhilan Health has also cooperated with more than 300 top three hospitals across the country to jointly develop digital therapy and application centers, and has carried out relevant cooperation with the China Center for Disease Control and Prevention, Guangzhou Respiratory Health Research Institute, Chubao Foundation, China Hepatitis Prevention and Control Foundation, etc., and participated in a number of national medical research projects.
The Zhilan Health CDMO service can help shorten the construction period of the core work by more than 50%.
The most critical step in market access for digital therapies is to obtain NPPA approval. Zhilan Health's hepatitis B maternal and infant blocking digital therapy products are the first batch of digital therapy certified products in China, and they have the successful practical experience of listing registration regulations, digital therapy product registration, and filing services.
Zhilan Health has also established a set of standardized processes, and established liaison channels for review agencies covering Zhejiang Province, Guangdong Province, Hunan Province, Hainan Province, Shanghai, Tianjin, Chengdu and other parts of the country.
In addition, there is a lack of unified standards for the review and approval of digital therapies, and regulators at all levels are still exploring. In the process of formulating these industry standards, Zhilan Health actively participates in and continuously exports relevant opinions and professional understanding to regulatory authorities and clinical experts.
Empower customers and achieve win-win results
In addition to drugs and devices, digital therapy provides a completely new way of treatment, and is an important innovation in the medical field based on evidence-based medicine and real-world research evidence to prove its clinical efficacy and safety.
Compared with hundreds of thousands of millions of gene therapies, cell therapies and other innovative treatment methods, its medical costs are lower, access is more optimistic, suitable for large-scale use, reduce treatment costs. At the same time, most digital therapies have good disease prevention and control functions, and they can also help patients and the whole society to effectively carry out medical cost savings.
Gao Yunlong said in an interview: "Our role is to empower our partners. He believes that the position of the CDMO industry in the overall digital therapy industry ecological environment is actually determined by the essential attributes of its industry. Playing its own role, empowering global pharmaceutical devices, wearables, games and digital therapy partners, and accelerating the listing process of digital therapy products, the CDMO industry can certainly play a key role in promoting the entire digital therapy research and development ecology.
It is reported that Zhilan Health will launch digital therapy CDMO and full-process services at the end of 2021. In just half a year, the company has approached more than 40 companies with digital therapy product incubation needs and provided in-depth services to a number of enterprises.
"In terms of the entire development process, digital therapy has experienced less than 5 years from the concept of 2017 to the global rise in 2021, entering the commercialization verification, far faster than other segments of medical treatment." It is foreseeable that the promising and over-10 billion digital therapy track will become more and more crowded in the future, and the "gold diggers" will not be exhausted. But from a business point of view, the answer to who can continue to get a piece of the pie is always "water sellers".