Recently, tralazili hydrochloride for injection has been approved for import, registration, and marketing by the National Drug Administration. This is the third drug variety approved for the Hainan Clinical Real World Data Application Pilot Program, and also another pilot drug variety approved for marketing after the approval of Flupronil intravitreal implants on June 16 this year. The interval between the two is less than one month, indicating that the pilot work is achieving more and more new results.
Trasylide hydrochloride for injection is an innovative chemotherapy based bone marrow protection drug developed in collaboration with G1 Therapeutics in the United States. Its indications are for prophylactic administration in patients with widespread small cell lung cancer receiving platinum containing drugs combined with etoposide to reduce the incidence of chemotherapy induced bone marrow suppression.

In August 2021, this variety was included in the pilot scope of Hainan clinical real world data application, and in November of the same year, the National Drug Administration accepted the application for listing and registration of this variety. On July 12, 2022, the National Food and Drug Administration approved the listing of this variety.
The approval of the launch of tramadol hydrochloride for injection not only reflects another milestone in the deepening of the real world data application pilot work in Hainan Boao Lecheng, but also reflects the support of the National Drug Administration for the real world data application pilot work in Lecheng.
In order to accelerate the review of this product, Lecheng Administration actively provided advanced services from plan drafting, data collection, product testing, and registration application submission. It fully utilized the coordination mechanism with the National Drug Administration Drug Evaluation Center and Hainan Provincial Drug Administration, and communicated and coordinated multiple times with the National Drug Administration Drug Review Center and Hainan Provincial Drug Administration to hold pilot variety communication meetings. The National Drug Administration Drug Review Center and Hainan Provincial Drug Administration followed up throughout the process, Provide full process tracking and guidance for drug registration applications. The Lecheng Management Bureau is also providing active assistance in coordinating with landing medical institutions and patient recruitment. In addition, during the process of accelerating the evaluation of tralazili hydrochloride for injection, the expert team led by the President of Hainan Real World Data Research Institute provided timely consulting services to enterprises, guiding them in designing real world research plans and conducting statistical analysis.

Thanks to the strong support and guidance of the Drug Evaluation Center of the State Food and Drug Administration and the Hainan Provincial Drug Administration, a real-time declaration system has been implemented for drug pilot varieties. After the licensed pharmaceutical equipment is put into use, enterprises can develop a comprehensive real world research plan to apply for pilot varieties to the provincial bureau and the Drug Evaluation Center of the State Food and Drug Administration. Based on the previous coordination mechanism for drug real world data application pilot projects, this year the National Bureau Drug Evaluation Center and the Hainan Provincial Drug Administration Drug Evaluation Center The Southern Provincial Drug Administration further improves the communication and exchange procedures for pilot varieties and refines the guidelines for application materials, and clarifies that there are no time and frequency limits for the communication and exchange meetings between the National Drug Administration Drug Examination Center and enterprises for pilot varieties. The above measures provide timely and efficient solutions for the problems encountered by enterprises in the process of applying for product registration using Lecheng real world data Introduction by Fu Zhu, Deputy Director of the Lecheng Pilot Zone Management Bureau and Vice President of Hainan Real World Data Research Institute.

The pilot varieties are of great significance in accelerating the approval and listing of global innovative pharmaceutical and mechanical products in China through the use of real world clinical data from Hainan Boao Lecheng, and in better meeting the needs of the people for high-quality medication and equipment. Relying on the "fast track" of pilot work in Hainan, 8 international innovative pharmaceutical products have accelerated their approval and listing. In the future, Lecheng Administration will, with the support of multiple departments such as the provincial drug supervision, health, and customs, deepen institutional integration and innovation, effectively solve the difficulties and problems encountered in real-world data application pilot projects, strive for more breakthrough results, and contribute the "Hainan Power" to the reform of the national drug review and approval system, benefiting more Chinese patients.