China's 13th Five-Year Strategic Emerging Industries Plan Highlights Biotech and Smart Healthcare Innovations

The State Council recently issued the “13th Five-Year Plan for the Development of National Strategic Emerging Industries” (hereinafter referred to as the “Plan”), which was published on the Chinese government website on December 19. The content related to the pharmaceutical industry mainly focuses on biotechnology. The Plan proposes that by 2020, the scale of the bioindustry will reach 8–10 trillion yuan, and a number of new biotechnology enterprises and bioeconomic clusters with strong international competitiveness will be formed. In the pharmaceutical field, leveraging the rapid development of gene technology, healthcare will be promoted toward precision medicine and personalized medicine.

As indicated in the “Plan,” key directives for the healthcare and pharmaceutical sectors primarily focus on the following areas:

Expand the application of “Internet Plus” in daily life and public services. Accelerate innovation in industry management systems to promote the smart transformation of services in healthcare, education, social security, employment, transportation, and tourism.

Promote the application of artificial intelligence technologies across various sectors. Launch pilot demonstrations in key areas such as manufacturing, education, environmental protection, transportation, commerce, healthcare, cybersecurity, and social governance to drive the large-scale adoption of AI. Develop diversified, personalized, and customized intelligent hardware and smart systems, with a focus on advancing the research, development, and industrialization of smart homes, intelligent vehicles, smart agriculture, intelligent security systems, smart health solutions, intelligent robots, and smart wearable devices.

In the process manufacturing sectors—including petrochemicals and chemicals, steel, non-ferrous metals, building materials, textiles, food, and pharmaceuticals—carry out integrated innovation and application demonstrations of smart factories to enhance enterprises’ intelligence levels in resource allocation, process optimization, process control, industrial chain management, quality control and traceability, energy conservation and emission reduction, and work safety.

Promote the leapfrog upgrading of the biopharmaceutical industry. Accelerate the research, development, and application of technologies such as gene sequencing, large-scale cell culture, targeted and long-acting drug delivery, and green intelligent manufacturing to support high-end industrial development. Develop novel biological products and formulations, including new antibodies and vaccines, gene therapies, and cell therapies; promote innovation in chemical drugs and the development of high-end formulations; accelerate the R&D of distinctive innovative traditional Chinese medicines; and achieve original innovations in drugs for the prevention and treatment of major diseases.

Support the scaled-up development of biosimilars, carry out R&D and manufacturing of major drug products whose patents have expired, accelerate the upgrading of pharmaceutical equipment, and enhance the level of automation, digitalization, and intelligence in pharmaceutical manufacturing. Further promote the standardization of traditional Chinese medicine (TCM) products, align the industrial standard system with international standards, and accelerate internationalization. Develop innovative marine drugs, create modern marine TCM products with ethnic characteristics, promote the industrialization of reagent raw materials and intermediates, and establish a number of marine biopharmaceutical industry clusters.

Innovate regulatory approaches for biopharmaceuticals. Establish more scientific and efficient drug review and approval processes, accelerate the nationwide implementation of the pilot Marketing Authorization Holder (MAH) system, expedite consistency evaluations of generic drugs in terms of quality and efficacy, and explore pilot programs for the recognition of clinical research involving new medical technologies. Improve drug procurement mechanisms and comprehensively advance institutional reforms in areas such as pharmaceutical pricing and industry regulation.

Develop new types of intelligent and mobile medical devices. Develop smart medical devices, their accompanying software and reagents, comprehensive telemedicine service platforms and terminal equipment, advance mobile healthcare services, establish relevant data standards to promote interoperability, and initially build a modern intelligent healthcare service system characterized by the deep integration of information technology and biotechnology.

Develop high-performance medical devices and core components. Advance high-quality medical imaging equipment, advanced radiotherapy devices, high-throughput low-cost gene sequencers, gene editing instruments, rehabilitation medical devices, and other medical equipment, significantly enhancing the stability and reliability of medical devices. Leverage new technologies such as additive manufacturing to accelerate innovation and industrialization of tissue and organ repair and replacement materials, as well as implantable and interventional medical device products. Accelerate the development of new in vitro diagnostic instruments, equipment, and reagents, promote the advancement of new technologies such as highly specific molecular diagnostics and biochips, and support rapid and accurate in vitro diagnostic screening for tumors, genetic diseases, and rare diseases.

Establish a bioprocess system based on biological methods that ensures ecological safety, promotes low-carbon and green practices, and supports circular development. Develop highly efficient industrial biocatalytic conversion technologies to enhance the application level of green bioprocessing. Establish biocatalytic synthetic routes for steroid drugs, chiral compounds, and rare sugar alcohols, thereby achieving green and large-scale production of intermediates for the pharmaceutical and chemical industries. Promote the comprehensive adoption and demonstration of green bioprocessing in agriculture, chemical engineering, food, pharmaceuticals, light industry and textiles, metallurgy, energy, and other sectors, significantly reducing material and energy consumption as well as pollutant emissions.

Enhance the biotechnology sector’s capacity to deliver specialized services to consumers. Develop specialized diagnostic and treatment institutions, and cultivate service providers for novel technologies such as standardized liquid biopsy and genetic diagnosis. Expand health management services, including health check-ups, consultations, and mobile healthcare. Promote the establishment of shared platforms for biological and medical big data, pilot the creation of personal health imaging records for residents, encourage the development of intelligent diagnostic and therapeutic ecosystems that integrate online and offline services, and advance the specialization of medical laboratory testing, imaging diagnostics, and related services.

Enhance the support level of biotechnology services for the industry. Develop drug research and development and manufacturing services that comply with international standards, and encourage pharmaceutical companies to strengthen collaboration with contract research organizations (CROs) and contract manufacturing organizations (CMOs). Promote the application and commercialization of emerging technologies such as genetic testing and diagnostics across various sectors, and support bioinformatics service providers in upgrading their technical capabilities. Provide public services—including testing, evaluation, and certification—for biological products such as pharmaceuticals, medical devices, seed industries, and bioenergy, so as to accelerate product market approval and improve product quality.

Establish a new medical model based on stem cell and regenerative technologies. Accelerate the strategic deployment of research and development in somatic cell reprogramming science and technology, and develop novel technologies for acquiring functional cells. Improve production platforms and facilities for cells, tissues, and organs both in vitro and in vivo. Standardize laws, regulations, and standards in the field of stem cells and regeneration, enhance intellectual property evaluation and commercialization mechanisms, and continuously deepen the clinical application of stem cell and regenerative technologies. Advance tumor immunotherapy technologies.

Advance the research, development, and application of gene-editing technologies. Establish a gene-editing technology system with independent intellectual property rights, and develop novel gene therapies targeting major genetic disorders, infectious diseases, and malignant tumors. Build relevant animal resource platforms, clinical research centers, and translation and application bases to promote the clinical translation and industrialization of gene-editing research.

Advance the reforms to streamline administration, delegate power, strengthen regulation, and optimize services. In sectors such as telecommunications, new drugs and medical devices, and market access for new energy vehicle production, further improve approval processes, minimize pre-market entry restrictions to the greatest extent possible, and amend or abolish administrative regulations and normative documents that hinder development, thereby stimulating the vitality of market entities. Adhere to the principle of combining deregulation with effective oversight, differentiate based on specific circumstances, and actively explore and innovate regulatory approaches suited to the development of new technologies, new products, new business formats, and new models, so as to both stimulate innovation and creativity and mitigate potential risks.

For new business models such as “Internet Plus” and the sharing economy, where development prospects and potential risks are clearly understood, tailor-made regulatory frameworks should be developed. For areas with uncertain outlooks, monitoring and analysis should be strengthened to encourage inclusive growth and avoid overly stringent or rigid regulation. For sectors with significant potential risks that could lead to serious adverse social consequences, regulation must be substantially reinforced. Activities conducted under the guise of innovation but essentially constituting illegal operations shall be resolutely banned. Strictly implement all policy measures aimed at reducing costs for enterprises in the real economy, carry out relevant policies concerning the management of funds for central government-funded scientific research projects, and advance reforms in the system of property rights over scientific and technological achievements.

Create a market environment for fair competition. Improve the supporting rules of the Anti-Monopoly Law, further strengthen law enforcement against monopolistic and unfair competitive practices, and seriously investigate and deal with illegal activities by enterprises in fields such as information services and medical services. Establish and improve working mechanisms to ensure the orderly implementation of the fair competition review system, break regional blockades and industry monopolies in areas such as renewable energy power generation, medical devices, and drug bidding, and increase efforts to investigate and deal with local protectionism and industry monopoly behaviors.

It is also worth noting that the section of the Plan titled “Promoting the Clustered Development of Strategic Emerging Industries and Building a New Pattern of Coordinated Development” proposes to drive the Shandong Peninsula Urban Agglomeration to prioritize the development of the biopharmaceutical sector, and to encourage the Northeast region to vigorously develop industries such as biopharmaceuticals and medical devices.