China's '818 Decree' Draws 100+ Submissions as Greater Bay Area Builds Integrated Clinical Research Ecosystem
核心洞察
China's national '818 decree' on clinical research and biomedical technology translation took effect May 1, with more than 100 projects already submitted to the National Health Commission for registration.
The decree creates a dual-track regulatory framework combining traditional NMPA registration with a parallel pathway for clinical trials, translation and commercialization of advanced biotechnologies.
China's NMPA approved 76 innovative drugs in 2025, up from 48 in 2024 and the highest total in history, according to the agency.
China's national regulation governing clinical research and the translation of advanced biomedical technologies — known as the "818 decree" — has drawn more than 100 project submissions to the National Health Commission since taking effect on May 1, according to Li Yichong, director of the Greater Bay Area International Clinical Trials Center (搜索) (Bay Trial).
Speaking at BIOHK 2026, Asia's flagship annual biotechnology conference and exhibition, Li said the decree enables high-quality medical innovations by establishing a dual-track regulatory framework. That framework combines traditional National Medical Products Administration (搜索) (NMPA) registration with a parallel pathway for clinical trials, translation and commercialization of cutting-edge biotechnologies.
Li added that the robust infrastructure in the Greater Bay Area (GBA) is positioned to help multinational companies capitalize on these emerging opportunities.
Regulatory Reform Meets Record Drug Approvals
The regulatory shift comes amid a period of rapid expansion in Chinese drug innovation. According to China's NMPA, the country approved 76 innovative drugs in 2025, up from 48 in 2024 — the highest total in history.
Song Ruilin, chief expert of the China Pharmaceutical Innovation and Research Development Association (搜索) (PhIRDA), said the Chinese government in 2026 included the biopharmaceutical industry as an emerging pillar for the first time. To sustain momentum, Song said the sector must overcome growing international friction — most notably defensive US trade policies — to ensure Chinese-led drug innovations continue reaching global patients' needs.
Jonathan Symonds, chair of the board of GlaxoSmithKline (GSK), described China as being in an explosive growth phase. "China is currently in an explosive growth phase where much of the world's most exciting scientific research is being conducted here, especially in the Greater Bay Area," Symonds said at the opening ceremony on Wednesday. He also noted that China's 15th Five-Year Plan (2026-30) highlights preventive healthcare, which he said is no longer just a medical objective but a foundational pillar for driving long-term economic productivity and societal resilience.
Hong Kong Positioned as Regulatory and Investment Bridge
Bernard Cheung Man-yung, CEO of the Greater Bay Area International Clinical Trial Institute (搜索) (GBAICTI), said the GBA is pursuing an integrated approach spanning clinical trials, regulatory innovation, data resources and industry cross-collaboration. He encouraged stakeholders to think beyond individual organizations and sectors to build a connected ecosystem that generates real impact.
Leveraged by the "one country, two systems" framework, Cheung said the Hong Kong Special Administrative Region is strategically poised to streamline clinical development — not only to accelerate local patients' access to novel therapies but also to reshape global healthcare innovation.
Hong Kong SAR Financial Secretary Paul Chan Mo-po said companies establishing a presence at the Hetao co-operation zone and the San Tin Technopole — a strategic infrastructure within the Northern Metropolis — can tap into both international and Chinese mainland R&D resources to develop products fitting for both markets. Chan said five of the world's top 10 pharmaceutical companies have chosen Hong Kong as their regional R&D base, and noted that global biotech fundraising reached approximately $70 billion last year, an increase of more than 10 percent, while the value of deals approached $300 billion, an all-time high.
Albert Yu Cheung-hoi, chairman of the Hong Kong Biotechnology Organization (搜索) (HKBIO) and president of BIOHK 2026, said in his keynote that Hong Kong serves as a high-value bridge for life sciences innovation worldwide. He added that the establishment of the Hong Kong Centre for Medical Products Regulation (搜索) (CMPR) at the end of this year will transform drug regulatory efficiency. The CMPR aims to align Hong Kong's standards with international certification systems to enhance the city's competitiveness in global drug regulation, clinical recognition and cross-border market access, he said.
Infrastructure and Talent Development
Both GBAICTI and Bay Trial are located at the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone. Alex Kwong, associate director of ecosystem development at the Hong Kong-Shenzhen Innovation and Technology Park (搜索) (HSITP), said that over the past year HSITP has completed its first wet-laboratory building, delivering purpose-built facilities for life sciences that provide specialized infrastructure for trials, diagnostics, therapeutics and R&D activities.
Talent development is also a focus of the region's build-out. GBAICTI signed a memorandum of understanding with Amgen, the Thousand Oaks, California-headquartered biotechnology company, to foster cross-boundary collaboration in biomedical innovation within the Guangdong-Hong Kong-Macao Greater Bay Area. The two organizations said their collaboration will focus on scientific exchange, talent development and leveraging high-quality real-world evidence to enhance healthcare delivery.
The initial phase of that collaboration will include exploring innovative study models, generating decision-grade evidence, accelerating its translation into clinical practice, and strengthening expertise in evidence generation and biostatistics. The partnership will also involve local tertiary institutions in developing training programs to nurture the next generation of clinical research expertise in the region.
Bernard Cheung said the partnership with Amgen underscores GBAICTI's commitment to building a high-quality, interconnected research ecosystem linking Hong Kong with international partners. Kara Cheung, general manager of Amgen Hong Kong, highlighted Amgen's belief that innovation is most impactful when scientific evidence is practically applied to improve patient care. Amgen has pledged to contribute its scientific expertise and international experience in clinical research and real-world evidence, complementing GBAICTI's clinical and academic network.
GBAICTI, wholly owned by the HKSAR government, serves as a one-stop support platform for clinical trials and plays a central role in enhancing the Greater Bay Area's status as a world-class hub for scientific research, according to the institute.
Financial and Industry Partnerships
At the event's opening, CITIC Group (搜索), China's state-run multinational conglomerate, signed a strategic partnership agreement with HKBIO aimed at uniting financial services, clinical R&D, international capital and manufacturing hubs to create an ecosystem that fast-tracks development of high-impact pharmaceuticals and medical technologies.
Sherman Fung, an overseas fellow of the Royal Society of Medicine and former director of SGS Hong Kong Ltd's Bio-Science division in China and the Hong Kong SAR, told China Daily that multinational pharmaceutical companies are continuing to forge collaborations in the Greater Bay Area, underscoring that medical advancements are not confined to the efforts of a single system. By adhering to scientific principles, enhancing clinical trial quality and bolstering data transparency and ethical governance, he said the Greater Bay Area has the potential to bridge diverse systems and dialogues. "This collaborative approach could influence the speed and safety with which innovative drugs reach patients in need," he added.
The four-day BIOHK 2026 conference and exhibition is hosting 50 forums and features over 400 professional speakers, 200 exhibitors from more than 40 countries and regions, and 10,000 visitors — twice the size of the previous year, according to the organizer.