As the two sessions are underway, a piece of good news came from the Lecheng Pilot Zone on the coast of the South China Sea that two innovative medical products were approved by the NMPA for registration after using real-world data of Lecheng to support their clinical evaluation. This is an important milestone marking the advancement of the pilot program of real-world data application in Lecheng, a new fruit achieved by the NMPA in support of the construction of Hainan FTP as well as a vivid reflection of multiple departments working together to promote institutional integration and innovation.

Hainan FTP is mentioned twice in this year’s governmental work report, which points out that in the past year, the reform was deepened and opening up was expanded, and the business environment was improved continually. New measures for the opening up of Hainan FTP were released. As a major park and functional platform in the construction of Hainan FTP, when the Two Sessions of 2022 are held, the Lecheng Pilot Zone has presented a gift to the Two Sessions by boosting the construction of Hainan FTP with concrete actions and innovation achievements.

The products approved this time were the thermal steam treatment equipment and disposable thermal steam treatment device for prostate produced by Boston Scientific. The products use thermal steam to melt the prostate tissue to reduce the size of lesion, providing a new therapy for the treatment of benign hyperplasia of prostate, which has won multiple international patents. Compared with drugs and other minimally invasive surgery, their application is safer and more efficient, which can be used in outpatient surgery and general anesthesia is not required. With a short time of surgery, it takes an average of 5-8 minutes only. The perioperative adverse reactions are mild. With a good and stable therapeutic effect, they can obviously improve the symptoms of lower urinary tract.

Based on the pilot policies of the Lecheng Pilot Zone, on December 12, 2020, the domestically first surgery of prostate melting surgery with thermal steam was finished smoothly at the Boao Yiling Life Care Center in Lecheng Pilot Zone. So far, near a hundred mid-and-old aged patients have benefited from the innovative technology.

The pilot program of real-world data application is a great institutional innovation in Hainan as well as a major exploration in the national reform of medical products review and approval system. In recent years, based on the “Double Nine Preferential Policies” of the state, by launching clinical evaluation assisted by real-world data at the Lecheng Pilot Zone, new breakthroughs have been successively achieved in the approval and registration of global innovative medical products in China. 23 medical products have been included into the pilot program of real-world data application in succession, including 9 drugs and 14 medical devices. Earlier, two foreign medical devices and one drug were approved by the NMPA for marketing after passing the clinical evaluation assisted with the real-world data of Lecheng.

The two newly approved products launched real-world study at medical institutions of Lecheng Pilot Zone in July 2021. In the last third of October, they formally submitted the application for registration, which were approved at the same time recently, refreshing the “speed of Lecheng” to accelerate the domestic marketing of global innovative medical products. The approval and registration of the two products will benefit more domestic patients of benign prostate hyperplasia, indeed ease the disease burden of the mid-and-old aged patients and help realize the “healthy aging”.

The approval and registration of the two products this time has once again proven that Lecheng Pilot Zone has become a main channel for global innovative medical products to enter Chinese market. In the future, Lecheng Pilot Zone will continue to remain true to its original aspiration of “serving the people’s health” and adhere to the development concept of “putting the people and lives at the most important position”. It will make full use of the good opportunities from the settlement of quality medical resources such as large public hospitals like Shanghai Ruijin Hospital and Western China Hospital in Lecheng for development, actively explore the use of real-world data in the registration and regulatory decision-making practice of medical products, firmly promote the pilot program to make more and bigger achievements so as to better satisfy the demand of the people for health and boost the construction of “Healthy China 2030”.