Guangdong promotes the development of biomedicine and strives to exceed the scale of one trillion industrial clusters by 2027
On October 9th, officials from the Guangdong Provincial Government gathered for a press conference to unveil the “Action Plan for Further Promoting the High-Quality Development of Guangdong’s Biomedicine Industry,” commonly referred to as the “Plan.” The officials underscored that the focus of the Plan is on enhancing innovation mechanisms, improving product quality, fostering industry clusters, and creating a supportive environment. It outlines 38 key tasks and measures aimed at achieving a biomedicine and health industry cluster worth over a trillion yuan by 2027, with the pharmaceutical sector targeted to exceed 500 billion yuan. This initiative is part of Guangdong’s broader goal to emerge as a leading province in the biomedicine field.
At the heart of the Plan is the initiative for mutual recognition of clinical research ethical review results throughout the province. There’s a strong emphasis on optimizing institutional mechanisms and enhancing coordination to drive industrial development.
Guangdong aims to establish a highly efficient collaborative framework for advancing the biomedicine industry’s development, guided by a “chain leader.” This strategy seeks to strengthen cooperation among three key healthcare sectors—medical services, medical insurance, and pharmaceutical services—while ensuring seamless coordination at every level, including research and development, approval, production, operations, applications, and regulation.
Another significant aspect of the Plan is its encouragement for public hospitals to engage in innovative drug and medical device clinical trials. Public hospital performance evaluations will now factor in their support for these trials, and there are plans to form a mutual recognition alliance for ethical reviews in clinical research. Leading hospitals in the province are expected to gradually participate, with an open invitation for foreign-invested, joint venture, private, and shareholding hospitals to join the initiative.
The document also emphasizes the importance of intellectual property trading centers and operational agencies, urging an increase in efforts to transfer patents and drive industrialization. There’s a clear goal to gather relevant patent technologies and facilitate their implementation in the Guangdong-Hong Kong-Macao Greater Bay Area. Additionally, the government is exploring national support to establish a national biomedicine intellectual property operation agency in Shenzhen, within the Hong Kong and Macao Innovation Cooperation Zone.
By 2027, the Plan aims to nurture at least 15 firms that each have a valuation exceeding 10 billion yuan. It proposes implementing early intervention mechanisms and special review processes for innovative drugs and medical devices to expedite market entry. The objective is to secure registration for one to two innovative drugs and over five innovative medical devices annually, focusing on emerging fields like gene technology, cell therapy, AI in biomedicine, synthetic biology, and brain science.
The government also plans to promote significant scientific infrastructure projects, including the second phase of the national gene bank and the human cell lineage facility, while seeking to bring the International Initiative on Human Proteomics to Guangzhou. Support will be provided to establish a joint laboratory between the Guangzhou laboratory and the National Institute for Food and Drug Control in Shenzhen, enhancing the safety evaluation of cutting-edge medical devices.
Furthermore, Guangdong is intent on attracting and developing key pharmaceutical companies. By 2027, regional cooperation between provincial and municipal governments will aim to recruit at least 15 enterprises valued over 10 billion yuan. The strategy includes fostering specialized and innovative companies, identifying “unicorns,” and setting up regional centers for both domestic and international pharmaceutical enterprises. Efforts will also focus on assisting biomedicine companies in their listings on suitable domestic and foreign capital markets.
To tackle concerns about sluggish approval processes and challenges in hospital entry for drugs and devices, the Plan proposes a collaborative service mechanism with the National Medical Products Administration’s technical review center. It aims to create special review procedures for key products and intends to cut approval times for second-class medical devices by an average of 50%, reducing initial registration reviews from 60 working days to 40.
In addressing the difficulties drugs and devices face in entering hospitals, the Plan mandates quarterly meetings for the pharmacy management and medical device management committees in public institutions. A fast-track procurement process for innovative drugs and devices will be put in place, ensuring that procurement is completed within 15 working days following the submission of documentation. New initiatives will also be introduced to facilitate the transition of innovative results to clinical applications.
Lastly, Guangdong is poised to capitalize on its strong foundation in traditional Chinese medicine. The Plan outlines efforts to explore unique traditional medicinal formulations from local clinical institutions, promoting the selection of “Lingnan Famous Formulas” while establishing a database for these formulations. There will be efforts to bolster policies supporting the transformation of these formulations into new drugs, streamline the registration and filing processes for medical institution formulations, and target a 50% faster approval time than legal requirements. Additionally, the Plan aims to encourage the collaborative development of Chinese medicine standards across the Greater Bay Area.