On August 22, a themed event on high-quality development of innovative biomedical technologies was held at the venue of the Guangzhou Medical Expo, drawing industry-wide attention to cutting-edge tracks including cell therapy, gene therapy and brain-computer interfaces. The State Council Decree No. 818, namely the Regulations on the Administration of Clinical Research and Translational Application of Innovative Biomedical Technologies (referred to as the "Decree 818" within the industry), has been officially implemented since May 1, 2026. It has ended the previous ambiguous regulatory era for innovative biomedical technologies in China and ushered in a legalized two-track governance system covering both pharmaceuticals and medical technologies. While thoroughly studying the new regulations, Guangdong has built translational platforms to fully address the long-standing industrial pain point of research achievements lying idle only on papers.

Cheng Wei, Deputy Director of the Science, Education and Technology Division, Guangdong Provincial Health Commission

Guangdong Boasts Unique Innovation Advantages

Issued on September 28, 2025, Decree 818 fills institutional gaps for cutting-edge medical technologies such as cell and gene therapies, which feature high personalization and are difficult to fully standardize for industrialization. Complementing the regulatory systems for drugs and medical devices, it paves a compliant, risk-controllable pathway for new technologies to move from labs to clinical practice.

During the regulation promotion session at the event, Cheng Wei stated that innovative technologies such as cell therapy, gene therapy and brain-computer interfaces are iterating rapidly and bring brand-new treatment options for intractable diseases. However, innovations targeting cellular and molecular levels carry high uncertainty regarding long-term risks. Recent public opinion incidents related to domestic gene therapy clinical trials have sounded an alarm for the whole industry: innovation must never cross the safety red line.

"Safety is an inviolable bottom line, standardized regulation is the institutional guarantee for fair development, and innovation is the goal of high-quality growth," Cheng Wei remarked. The issuance of the Regulations coordinates technological innovation, medical quality and people’s life and health, encouraging exploration while enforcing strict risk prevention.

At the national level, complete supporting documents have been rolled out to support implementation this year, including implementation guidelines, technical guiding principles, filing instructions, translational approval specifications and risk classification guides. A unified national online service platform has been launched, and the China National Center for Biotechnology Development has optimized full-cycle procedures for filing, review and translational approval. Nationwide training sessions have also been arranged to provide clear operational guidance for the industry.

As a major province for the biomedical industry, Guangdong possesses unmatched innovation strengths: it ranks first nationwide in the number of Grade A tertiary hospitals and drug clinical trial institutions; major scientific infrastructure such as the Guangzhou Laboratory, CAS Guangzhou Institute of Biomedicine and Health and the National Gene Bank have settled here; the Guangzhou Bio Island and Pingshan Biopharmaceutical Industrial Base in Shenzhen are booming, forming a complete industrial ecosystem spanning basic research, clinical trials and industrial translation.

"Up to now, 20 clinical research projects on innovative biomedical technologies in Guangdong have completed filing, accounting for 20% of the national total and ranking first nationwide. The province has collected more than 200 plans and demands for new technology clinical research, and selected and recommended cutting-edge projects to advance clinical translation," he introduced.

He disclosed that Guangdong will carry out the following key work in the next stage: regular policy promotion and counseling services; optimized filing application and translational supervision; construction of provincial-level supporting service institutions and expert databases, with rosters of key institutions and projects for one-on-one incubation of high-quality programs; launch of major special research programs to tackle cutting-edge technologies, striving to achieve the first domestic clinical landing of a batch of new technologies, and build a national innovation source and demonstration hub for translational biomedical technologies.

Shi Yiran, Director of the Office, National University Regional Biomedical Technology Transfer & Translation Center

The Center Is Dedicated to Solving the "Last Mile" Bottleneck

Although policy access has been opened, researchers still face practical obstacles: numerous university laboratories produce high-quality papers and patents, yet few can be converted into new medicines for disease treatment. Shi Yiran pinpointed this widespread industrial dilemma at the event.

China’s basic biomedical research has reached world-leading standards, with its output of high-quality papers and patent applications ranking among the global top tier. Nevertheless, the translation rate remains low, with most research outcomes confined to papers and patents rather than clinical practice and markets. Three major barriers block university technology transfer: a shortage of professional translators, insufficient translational platforms and inadequate funding. Innovative drug R&D follows the "30 Rule": a decade of development, one billion US dollars of investment, and a success rate below 10%, discouraging many research teams.

The National University Regional Biomedical Technology Transfer & Translation Center (Guangdong-Hong Kong-Macao Greater Bay Area), located on Guangzhou Bio Island, was specially built to resolve this "last mile" challenge as an all-in-one service platform for achievement translation.

Shi Yiran elaborated that the center has built 23 core technical platforms, focusing on two core segments: cell & gene therapy and AI-aided pharmaceutical development, while covering hot fields including antibody drugs, small-molecule medicines, nucleic acid therapeutics and domestic substitute reagents. Adopting a combined grant-and-equity investment fiscal support model, the center collects projects from universities nationwide and classifies them into Seed, Key and Major projects based on maturity and industrialization feasibility.

• Early Seed projects with completed preliminary basic research at the cellular level: maximum funding of RMB 1 million

• Key projects with sufficient cellular & animal experimental data and preclinical proof-of-concept: maximum funding of RMB 5 million

• Major projects with clinical trial approvals or ongoing clinical research: maximum funding of RMB 10 million

Cooperating with the Ministry of Education, the center has established a regular university liaison system to track technology transfer demands of key universities, organize nationwide submission of biomedical cooperation intentions, and optimize matchmaking and translation procedures. To date, 1,015 projects from 86 universities nationwide have been submitted, covering cell therapy, gene therapy, AI pharmaceutical development, small-molecule drugs, protein & nucleic acid medicines and domestic alternative reagents. Continuous project solicitation will be maintained. After technical evaluation, qualification verification and comprehensive expert review, 228 projects have passed preliminary screening, 46 have completed panel assessment and official center recognition with public notice finished. Tripartite cooperation agreements have been signed for 25 projects, 23 have launched experimental verification, and 4 supporting enterprises have been registered. An additional 15 enterprises are expected to be registered in Q4, with a target of advancing 4 projects into clinical trials within this year.

Unlike traditional research grants, the platform enforces two strict core rules:

1. The combined grant-and-equity investment model integrates public subsidies and equity investment. Funds are not transferred directly to university accounts; project teams must settle in the center to utilize its full-range service platforms for translation and establish independent enterprises as the fund recipients.

2. All selected projects must repeat and verify key experimental data within the center to reproduce core results stated in papers and application materials; formal translation can only commence after data authenticity is confirmed to eliminate risks of data fraud. In addition, funding is disbursed in installments tied to R&D milestones rather than as a one-time lump sum.

Beyond platforms and capital, the center delivers a full set of supporting resources: dedicated professional technology managers accompany project teams throughout development; training programs cultivate compound talents with both research and industrial expertise; special doctoral enrollment quotas coordinated via the Ministry of Education are allocated to settled projects to nurture interdisciplinary translational talents. It also hosts the National University Student Life Science Challenge, adhering to the standards of real research problems, authentic raw data and reproducible verification to discover early-stage innovative projects. A RMB 500 million special initial fund has been set up to connect with social capital such as Guangzhou Pharmaceutical Capital to provide sustained financial support for mature projects.

From Decree 818 defining clear compliance boundaries at the national level, to local governments stockpiling clinical research resources, and all-in-one translational platforms filling gaps in capital, lab space and industrial talents, cutting-edge medical technologies such as cell and gene therapy are breaking free from the fate of being locked away as unpublished papers. By strictly safeguarding safety thresholds while unblocking pathways for innovative industrialization, Guangdong is realizing two-way integrated development of biomedical research and industrial application.

Source: Yangcheng Evening News