To fully implement the decisions of the Fourth Plenary Session of the 20th Central Committee of the Communist Party of China and General Secretary Xi Jinping’s series of important instructions on new productive forces and high-quality development in the food and drug industry, the island of Hainan Free Trade Port has been officially opened for trade operations, and our organization has successfully held the event.Frost & Sullivan Frost & Sullivan China LeadLeo Research Institute LeadLeo YUAN CAPITAL SULLIVAN TELE-TREND CLOUD TECHNOLOGY TradeGo MagnaTEC Automotive & Mobility Environmental Protection & Energy Saving Technology Logistics & Supply Chain MATERNAL AND INFANT Education & Training Real Estate & Property Catering & New Retailing Advanced Materials Healthcare & Life Sciences Semiconductor & Chip COMMERCIAL AVIATION Technology, Media and Telecom LANDSCAPING Big Data & AI Infrastructure Construction & Utilities Culture & Entertainment AGRICULTURE, FORESTRY ANIMAL HUSBANDRY AND FISHERY Food & Beverage Fintech SHIPPING AND PORTS Dual Carbon & New Energy Mining & Metals Public Sector Cross-Border E-commerce Trade Building Technology, Construction & Decoration Beauty & Fashion Smart Homes Digital Infrastructure Enterprise Services Consumer Electronics2025Under the background of the "China Food & Drug, Medical Devices and Cosmetics New Productivity and High-Quality Development Conference", Frost & Sullivan China serves the national development strategy, witnesses the remarkable achievements achieved through isolation, gathers resources and wisdom related to new productivity, and continues to support the modernization of Hainan Free Trade Port.2026The China Food & Drug, Medical Devices and Cosmetics New Productivity and High-Quality Development Conference held in2026Year5Month8Today11Held successfully in Sanya, Hainan Province, in YYYY/MM/DD, and10Frost & Sullivan holds the ''LeadLeo''' on that daymRNAWhere are the application boundaries of technology? "Parallel Forum. The key topics discussed at this parallel forum include the foundation for breaking through application boundaries."mRNAUnderlying technologies and boundary breakthrough engines –AIInnovation,818How Orders Affect...mRNAFrost & Sullivan invites renowned academicians, experts, and business elites from domestic and international fields such as pharmaceuticals and medical devices to discuss cutting-edge scientific achievements worldwide, establish a integrated development platform involving government, industry, academia, research, finance, and application, seek policy benefits for development, share global technological resources, and effectively promote high-quality and safe development of new productive forces in the "three products and one equipment" sector. Frost & Sullivan)Frost & Sullivan& Sullivan,Hereinafter referred to as'Frost & Sullivan'）Frost & Sullivan China’s Medical Health Division Consulting Director Chen Xiaorui was invited to attend and delivered a speech.
Chen Xiaorui, Consulting Director of Frost & Sullivan Frost & Sullivan China’s Medical Health Division
818Orders and828Frost & Sullivan has established a dual-track regulatory framework for biomedical innovation, ranging from clinical research to commercialization.818Orders and828The guidelines correspond to the "Clinical Research Registration–Translational Application" path and the drug registration and approval path of biomedical new technologies: The former focuses on the clinical validation and translational application of new technologies within compliant medical institutions, while the latter emphasizes the registration, market launch, and nationwide distribution of standardized drugs. These two paths differ significantly in terms of regulatory bodies, fee structures, and approval timelines, collectively forming a dual-track regulatory framework that covers biomedical innovation from early exploration to large-scale commercialization.
Chen Xiaorui stated thatFrost & Sullivan, along with Frost & Sullivan China, established a standardized pathway from "clinical research registration" to "translational application" while strengthening regulatory constraints, providing a institutional foundation for the clinical validation and translational application of cutting-edge technologies such as mRNA therapies within a compliant framework. This pathway operates parallel to the existing drug registration and approval process, offering differentiated implementation options for technologies varying in maturity and standardization levels. Order 818 specifies the evaluation and approval timelines for clinical translational applications, providing a more efficient path for the translation of advanced technologies.
The implementation of Order 818 will standardize and promote clinical research and application of new biomedical technologies, thereby accumulating valuable preliminary data resources for the entire biopharmaceutical industry. These safety and efficacy data obtained from real-world studies can serve as important references for subsequent drug applications once technology matures, reducing the cost of repeated trials and improving overall R&D efficiency and success rates. Additionally, the development of new technologies will drive innovation in upstream industrial chains, enhancing the standardization and replicability of the entire technology system. The relationship between technology and product development is not separate but can form a positive cycle where "technology incubates products, and products optimize technology." mRNA technology features a short development cycle and strong platform characteristics, allowing it to complete the entire process from sequence design and in vitro validation to GMP clinical sample preparation within a short time. Under the "clinician research registration—transformation application" pathway established by Order 818, tertiary medical institutions can conduct early clinical exploration within compliance frameworks, and collaborate with GMP-capable technical service providers to complete preparation and quality control, thus accelerating the clinical validation process of candidate products while meeting ethical and regulatory requirements. Compared to traditional development models that rely solely on drug registration, this mechanism provides a more operational clinical transformation pathway for advanced technologies like mRNA, helping to shorten the period from scientific research to clinical validation.
Chen Xiaorui further stated thatThe introduction of Order 818 will accelerate the differentiation within the mRNA industry: Projects lacking compliant clinical pathways and real data support will face greater elimination pressure, while companies with platform capabilities, a complete development system, and standardized clinical translation capabilities will further strengthen their competitive advantages. Meanwhile, capital evaluation criteria will shift from solely focusing on technical potential to emphasizing clinical feasibility, compliance, and commercial conversion capabilities.
Chen Xiaorui concluded thatFrost & Sullivan Order 818, while providing a standardized implementation pathway for cutting-edge technologies such as mRNA, also enhances the ethical compliance, safety management, and data reliability of clinical research through clear responsibility assignments, zero-fee research periods, regulatory constraints, and full traceability. In the short term, this policy will impose pressure on research and development timelines, commercialization strategies, and small enterprise operations, but in the long run, it will help streamline the industry, concentrate resources in companies with platform and systematic capabilities, and drive the mRNA industry toward high-quality, sustainable, and international development.
