Zhilan Health Innovates Digital Therapeutics CDMO Platform, Cutting Core Development Timeline by Over 50%

Currently, the ability to integrate the entire value chain has become a major challenge for most digital therapeutics companies and related enterprises.

In the advancement of the digital therapeutics industry, Hainan has taken the lead in introducing a series of supportive measures spanning clinical research, registration and approval, application promotion, and payment implementation. Theoretically, this is expected to significantly shorten the time-to-market for digital therapeutics products. However, to translate this potential into reality, enterprises urgently need comprehensive end-to-end capabilities to integrate the entire value chain.

Meanwhile, digital therapeutics CDMO services have also received policy support. The Several Measures of Hainan Province to Accelerate the Development of the Digital Therapeutics Industry explicitly states that it will “support the construction of digital therapeutics CDMO platforms in Hainan, and support CDMO and other platforms in conducting clinical trials and market-oriented collaborations with physical hospitals and internet hospitals in Hainan.”

Against this backdrop, the emergence of CDMO services for digital therapeutics was a natural progression. At the end of last month, SLANHEALTH was invited to attend the 6th Hainan International Health Industry Expo in 2022 and signed an agreement to establish its presence in the Hainan Eco-Software Park, becoming the first platform to settle in the park and provide full-lifecycle CDMO services for digital therapeutics.

It is reported that SLANHEALTH has established a digital therapeutics CDMO and full-process incubation system. By collaborating with its global ecosystem partners, such as manufacturers of smart wearable devices, IVD tests, and out-of-hospital equipment, SLANHEALTH provides digital therapeutics CDMO and end-to-end services to enterprises with digital therapeutics needs.

VCBeat recently conducted an exclusive interview with Gao Yunlong, CEO of SLANHEALTH, to explore the innovation and systematic approach of SLANHEALTH’s CDMO service platform.

Currently, pharmaceutical and medical device companies, wearable technology firms, gaming companies, internet healthcare providers, and tech companies are all actively positioning themselves in the development of digital therapeutics (DTx) products, while the number of DTx startups continues to grow.

However, regardless of the stakeholder, all face the challenge of validating the safety and efficacy of digital therapeutics (DTx) products. Product strength is the core metric for gaining physician endorsement and ensuring patient outcomes, as well as the cornerstone for subsequent commercial scale-up.

Gao Yunlong, General Manager of SLANHEALTH, told VCBeat that during the process of developing this product from scratch, digital therapeutics and related companies still have some unresolved issues, or new challenges have emerged.

First, digital therapeutics inherently possess the dual attributes of data algorithms and evidence-based medicine; relying solely on either internet product thinking or medical thinking for development has certain limitations.. The development of digital therapeutics products is constrained by the “barrel effect,” requiring compliance with evidence-based medicine and medical device regulatory standards, while also enhancing patient adherence through product design to ensure that their clinical application value meets the needs of both physicians and patients.

“The digital representation of evidence-based medicine is not a simple transfer of knowledge and functions; rather, it requires systematic, logical, and implementable integration. It must enable practical application scenarios and meet regulatory requirements at every stage, including product mechanism discovery, product design and development, efficacy validation, clinical trials, and product registration, review, and approval. This presents a novel challenge for digital therapeutics companies,” said Gao Yunlong.

Second, product R&D and regulatory registration filings are not pursued in parallel. Many companies mistakenly believe they can wait until product development is complete before preparing for regulatory submission.

However, preparations for regulatory approval should never be deferred until the registration and submission stage. Considerations must be integrated across all phases—from quality management system establishment and product initiation to product testing and clinical trials for registration—as this is a systematic endeavor. Failure to do so can easily result in delayed market launch, increased costs, or even product failure.

The underlying reasons are twofold. First, digital therapeutics (DTx) remains a relatively nascent field. As medical device products primarily driven by software, their development and market launch must be governed by medical device quality management systems. Treating DTx products merely as internet-based software products—a common pitfall for companies entrenched in internet product thinking—can easily lead to strategic missteps. Second, the essence of digital therapeutics lies in serious medicine; it involves embedding digital components into the entire healthcare delivery process, ultimately driving value-based healthcare and precision medicine.

Therefore, digital therapeutics companies must possess a high level of medical expertise and proficiency within their teams, along with strong interdisciplinary collaboration capabilities, while respecting medical principles and industry regulations. Their products must be supported by confirmatory clinical evidence and compliant data, effectively addressing clinical needs.

To address the aforementioned pain points and challenges, SLANHEALTH has innovatively proposed a CDMO model and end-to-end solution for digital therapeutics, encompassing digital therapeutic software, monitoring devices, integrated supply of pharmaceuticals and medical devices, and data service platforms.EndComplete service system.

SLANHEALTH empowers enterprises to enhance resource utilization through systematic, modular solutions, ensuring seamless integration and efficient operation across all stages. This approach can reduce the core work cycle by over 50%, enabling end-to-end project management for digital therapeutics and accelerating product time-to-market.

SLANHEALTH’s Digital Therapeutics CDMO and End-to-End Services Can Reduce Core Project Timelines by Over 50%

In the realm of evidence-based medicine-driven product digitalization and medical-engineering integration, SLANHEALTH possesses top-tier medical research capabilities within its digital therapeutics CDMO platform to ensure robust top-level product design.

Internally, SLANHEALTH’s specialized interdisciplinary team, combining expertise in both medical engineering and product development, integrates product-oriented and clinical mindsets. The team provides professional medical models and solutions to precisely uncover clinical value, organically combining evidence-based medicine with product implementation, thereby shortening clinical trial cycles while reducing trial risks. Additionally, SLANHEALTH has dedicated regulatory affairs and operations teams working in coordination to ensure the scientific rigor, compliance, safety, and effectiveness of its digital therapeutics products at every stage.

Externally, SLANHEALTH has assembled a team of more than 10 leading collaborative experts and academicians for its digital therapeutics projects across various product pipelines, along with a network of over 4,000 medical experts in digital therapeutics. Having managed care for more than 800,000 patients to date, the company boasts extensive experience in providing full-lifecycle health services.

Regarding the regulatory submission system, SLANHEALTH possesses a mature and comprehensive framework for digital therapeutic registration and holds the distinction of achieving China’s first successful digital therapeutic regulatory submission.

SLANHEALTH’s digital therapeutic for mother-to-child transmission blockade of hepatitis B, “Little Shell®,” received Class II medical device registration approval in November 2019, becoming China’s first approved digital therapeutic. Through this digital therapeutic, SLANHEALTH has explored key stages including mechanism discovery, product design and development, efficacy validation, clinical trials, and regulatory review and approval for product registration, successfully completing the entire process and establishing full-process CDMO incubation capabilities.

Leveraging Tigermed’s robust CRO capabilities, SLANHEALTH has established China’s only full-process platform-based service system for digital therapeutics CDMO services. It is the first to provide pre-market regulatory consulting services—including support for market registration, product registration, and filing—as well as post-market commercialization support services.

In the realms of data services and real-world research, SLANHEALTH’s digital intelligence platform, launched this year, provides professional information technology solutions and research acceleration services to sponsors, clinical research centers, national regulatory authorities, and third parties.This platform not only maximizes the activation of data value and accelerates the generation of real-world evidence, but also efficiently consolidates data assets to support the continuous iteration, optimization, and upgrading of digital therapeutics products.

According to reports, this digital-intelligence platform is independently developed by SLANHEALTH. Through a highly modular research data system, it meets the growing demand for “decentralized clinical trials”; enables rapid, efficient, and standardized system deployment, reducing research costs, accelerating patient recruitment, and improving recruitment retention rates; and supports final efficacy testing and practice based on large-scale real-world data, optimizing user effectiveness and experience.

“We aim to integrate the digital intelligence platform with wearable devices to supplement out-of-hospital data collection, including medical-grade data, and obtain regulatory approval. Future discussions on diversified applications will extend beyond digital therapeutics to also advance clinical trials and medical research,” introduced Gao Yunlong.

Based on this platform, SLANHEALTH has independently developed the "Little Shell" auxiliary management software for mother-to-child transmission blockade of hepatitis B.^®) Completed data governance for nearly 40,000 datasets in Phase II of the real-world study. This represents the largest-scale real-world study case in the field of digital therapeutics to date, with its research findings contributing to the revision of medical guidelines and the optimization of diagnostic and treatment protocols.

It is reported that, based on the clinical data outcomes of SLANHEALTH’s digital therapeutic for mother-to-child transmission (MTCT) blockade of hepatitis B, an expert panel revised the “Guidelines for the Prevention and Control of Mother-to-Child Transmission of Hepatitis B Virus in China (2019 Edition).” At the recently concluded 2022 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Little Shell^®The latest research data will also drive the World Health Organization to revise its 2030 target for eliminating mother-to-child transmission of hepatitis B.

Furthermore, this year SLANHEALTH has partnered with mainstream wearable device manufacturers to successfully incubate a CBT-I digital sleep therapy. This is a lightweight, precise, and intelligent non-pharmacological CBT-I digital sleep therapy tailored specifically for individuals with insomnia, establishing a comprehensive sleep health solution that integrates medical validation, product development, health management services, smart device connectivity, and the application of medical data models.

The incubation of the CBT-I digital therapeutic for sleep further validates the feasibility of SLANHEALTH’s CDMO platform, which is built on evidence-based medicine and disease-correlated data models, to leverage its R&D capabilities for the efficient development of DTx products.

In addition to verifying product safety and efficacy, commercialization and channel development are also major constraints currently facing digital therapeutics companies.

For digital therapeutics companies, ecosystem collaboration capabilities and resource accumulation are crucial. It is essential to establish connections with the broader industrial ecosystem, including medical institutions such as hospitals, hospital departments, experts, and physicians; payers such as public health insurance and commercial insurance providers; and partners such as pharmaceutical companies, medical device manufacturers, in vitro diagnostics (IVD) companies, and smart wearable device manufacturers.

As the “organizer,” SLANHEALTH integrates and empowers the construction of a digital product ecosystem, having already linked key partners such as smart wearable devices, medical devices, biopharmaceuticals, and IVD testing. This aligns closely with the inherent attribute of digital therapeutics to be used in combination with pharmaceuticals and medical devices.

Leveraging this ecosystem, SLANHEALTH will deeply integrate its years of accumulated product and platform expertise with customers' market demands and ecosystem capabilities,Provide open, modular solutions to enable dual collaboration in products and channels. By leveraging the digital intelligence platform’s innovative “ecosystem-linking” approach, demand-side enterprises are accelerated onto the “fast track” of digital therapeutics, enhancing their overall competitiveness and ultimately enabling clients to derive greater benefits from the ecosystem.

In terms of post-launch data operations, the SLANHEALTH Digital Intelligence Platform can also leverage patient health data generated from course-based digital therapy interventions and dynamic user feedback to help enterprises build a data closed loop, thereby optimizing overall effectiveness and enhancing user experience.

VCBeat has observed that digital therapeutics CRO platforms are gradually emerging overseas. Recently, Curavit, a virtual clinical trial CRO company, announced the completion of its $5 million Series A financing round and has already signed contracts with major digital therapeutics companies such as Swing Therapeutics and LarkHealth. This demonstrates that digital therapeutics companies share common demands for CDMO and end-to-end service platforms.

Gao Yunlong stated that SLANHEALTH’s digital therapeutics CDMO platform will continue to help digital therapeutics companies reduce resource investment and improve the efficiency of integrating key factors such as capital and talent, thereby creating greater economic and social benefits. The company plans to further enhance related functionalities and expand its services in the future.

SLANHEALTH believes: "Only when the waters are wide can the fish grow large." The digital therapeutics market can truly enter a phase of healthy development only when the entire industry becomes standardized.

SLANHEALTH has become a key driver in establishing industry standards for digital therapeutics through its own practices, covering liaison channels with review agencies across multiple provinces in China as well as associations related to digital therapeutics. It actively participates and continuously provides relevant opinions and professional insights to regulatory authorities and clinical experts, comprehensively promoting the upward and positive development of the digital therapeutics industry from aspects such as technological advancement, product research and development, talent cultivation, and policy guidance.