Shenzhen eases market access restrictions for innovative healthcare to support stem cell and AI therapies

On January 26, the Opinions on Several Special Measures for Shenzhen to Build a Pioneering Demonstration Zone of Socialism with Chinese Characteristics to Ease Market Access (hereinafter referred to as the "Opinions") was issued, which mentioned four articles related to the medical field, including relaxing market access restrictions for medicines and medical devices, piloting the sale of prescription drugs on the Internet, optimizing the approval and access services for human genetic resources, and relaxing the qualifications and business access restrictions of medical institutions.

Lu Hongzhou, president of the Third People's Hospital of Shenzhen, told the first financial reporter: "The Opinions cover 6 major areas and include 24 special measures to support Shenzhen to boldly break through and boldly try. In particular, it proposes an innovative market access mechanism in the field of medicine and health to support the research and development of new medical products and technologies such as stem cell therapy, immunotherapy, and gene therapy. ”

An expert in the field of cardiovascular medical devices told the first financial reporter: "The latest "Opinions" are piloted in Shenzhen and are expected to cover the entire Greater Bay Area in the future. ”

Innovative medical system first

In response to the provisions on relaxing market access restrictions for medicines and medical devices, the Opinions pointed out that it is necessary to support the promotion of real-world data applications in the clinical evaluation of local drugs and medical devices in Shenzhen, focusing on clinical evaluation in the fields of clinical urgent need, rare disease treatment, AI medical algorithms, precision medicine, traditional Chinese medicine, etc., to further accelerate the process of listing new products, and timely discover and control the risk of use of listed products. Accelerate the commercialization and clinical application of AI medical algorithms.

Ma Min, president of the domestic surgical robot company Tianzhihang, told the first financial reporter: "The latest policy introduced by Shenzhen is consistent with the general tone of the country's increased reform and opening up, and is also in line with the overall idea of the Boao Lecheng pilot system, which is bound to accelerate the approval and registration and clinical promotion of medical device companies and benefit patients as soon as possible." ”

Ma Min told the first financial reporter that the real-world data application of medical devices has been carried out in Boao, and the advantage is that it can eliminate the process of clinical trials of innovative products, directly used for patients, collect data in real-world use, and use it for evidence of subsequent registration approval.

"The clinical trial of innovative products is the most time-consuming and cost-consuming process for the entire medical device before it is launched, and the real world means that as long as you get relevant certifications abroad, such as CE or FDA certification, you can directly diagnose and treat patients in areas that are the first to try or allow real-world research." Ma Min said, "This also opens up the clinical and commercial aspects of the channel, allowing the industry to use the latest technology faster and accelerate the pace of adoption." ”

In response to the real-world data application pointed out in the "Opinions" to "focus on the clinical evaluation of AI medical algorithms and precision medicine", Ma Min told the first financial reporter that this will benefit the medical robot industry and will also promote the implementation of smart medical solutions.

The Boao Lecheng Pilot Zone has previously completed a number of "First Cases in China", including Siemens Medical Machine-assisted Coronary Intervention surgery. The relevant leader of the Lecheng Administration bureau said in an interview with the first financial reporter: "The creation of Lecheng is to allow innovative drugs and devices to enter the Chinese market faster. In the past, this process was relatively long, but now we have made breakthroughs in the system, and the most advanced technology in the world has been able to try first in Lecheng almost synchronously. ”

Shenzhen's latest policy also docks with Boao's first-in-first-served system. "Shenzhen's policy is very cutting-edge, and the opening up of medical devices and equipment will be accelerated in the future." A person in charge of a multinational medical device company told the first financial reporter.

Cell gene therapy has significant advantages

The "Opinions" also pointed out that the pilot to carry out Internet prescription drug sales, the establishment of Shenzhen electronic prescription center, for the domestic market sales of prescription drugs, in addition to the state clearly prohibited on the Internet drug, other allowed to rely on electronic prescription center for Internet sales, no further approval. Explore the use of digital yuan for transaction settlement; use blockchain and quantum information technology to achieve online and offline linkage supervision, full traceability of drug flows, and secure storage of data.

Chen Hua, CEO of Enterprise Internet Hospital Huiyi Tianxia, told the first financial reporter: "Following Hainan, the Shenzhen Electronic Prescription Center was supported by two ministries and commissions to establish, laying the foundation for the efficient and safe implementation of Internet prescription drug sales nationwide. In particular, the further opening of key links such as prescription drug medical insurance settlement and purchase has played a great demonstration and promotion role in the value upgrading of Internet medical care in the digital economy era, and we have also continuously explored in active practice. ”

The "Opinions" also propose to optimize the approval and access services for human genetic resources, explore the establishment of an approval and management platform for human genetic resources, support the research and development of new medical products and technologies such as stem cell therapy, immunotherapy, gene therapy, etc., optimize the approval procedures for human genetic resources activities involving international cooperation in clinical trials, implement risk classification and hierarchical management of human tissues, blood and other scientific research samples and laboratory reagents entering and leaving the country, and on the premise of ensuring biosecurity, give customs clearance facilities and use of low-risk special items. Do a good job of file registration in the process of flow and post-use destruction.

Shenzhen has rich genetic and stem cell research resources and strength. Lu Hongzhou told the first financial reporter: "In terms of stem cell research, Shenzhen talents gather, is a scientific and technological highland, many universities and hospital teams have projects in progress, the advantages are obvious. ”

Dr. Mao Mao, founder and CEO of Cancer Early Screening Startup Siqin Medical, told the first financial reporter: "In gene-related projects, international cooperation often involves human samples and corresponding genetic data, as a high-tech enterprise, under the current policy, we think that will require a lot of manpower and material resources, so we do not do international cooperation involving cross-border samples at present." We will re-evaluate future policies if there are any changes. ”

As one of the experts who participated in the review of the first edition of the Management Measures for Genetic Resources in the 1990s, Mao Mao said that the system of risk classification and hierarchical management for scientific research samples still needs to be refined.

A researcher engaged in organoid research in a hospital in Shenzhen told the first financial reporter: "The field of cell therapy in Shenzhen has driven the development of the entire industrial chain, including cell culture equipment, and the development of medical devices in Shenzhen also has advantages. ”

In addition, the Opinions also propose to relax the qualification and business access restrictions of medical institutions, delegate Shenzhen's authority to accept Hong Kong and Macao service suppliers to handle medical examinations and approvals in Shenzhen, and further optimize the approval process for the practice permits of Hong Kong and Macao wholly-owned and joint-venture medical institutions. Overseas medical technology backbones with excellent clinical experience or high peer recognition are encouraged to practice in depth in accordance with regulations. Explore the establishment of a hospital accreditation standard system that is in line with international standards. Support designated medical institutions open in Shenzhen to use drugs and clinical urgent needs that have been listed in Hong Kong and Macao, and medical devices with advanced clinical applications that have been purchased and used by public hospitals in Hong Kong and Macao, and explore the development of international remote consultations.