Recently, CoselaTM (trilaciclib）for injection was approved by the National Medical Products Administration for import registration and marketing. This is the third drug variety approved under the Hainan clinical real-world data application pilot project and is also addition to the fluocinolone intravitreal implant which was approved for marketing on June 16th of this year within less than one month, indicating that more and more new achievements will be made in the pilot work.

CoselaTM (trilaciclib）for injection is an innovative bone marrow protection drug developed by Simcere in cooperation with G1 Therapeutics, a U.S. company, which is indicated to give prophylactic administration to patients with extensive small cell lung cancer who receive platinum-containing drugs combined with etoposide to reduce the incidence of bone marrow suppression caused by chemotherapy.

In August 2021, this drug was included in Hainan clinical real-world data application pilot project, and in November, 2021, NMPA accepted the application for registration, and approved the marketing of this product on July 12, 2022.

The approval of CoselaTM (trilaciclib）for injection not only reflects another phased achievement in the deepening of the pilot work of real-world data application in Boao, Hainan, but also reflects NMPA’s support for the pilot project on the application of real-world data in Lecheng.

In order to help speed up the review of this product, Lecheng Pilot Zone Administration took the initiative to provide early services from drafting of plans and data collection to product testing, and submission of the applications, making full use of the tri-party coordination mechanism with NMPA Drug Evaluation Center and Hainan Provincial Medical Products Administration, repeatedly communicating and coordinating NMPA Drug Evaluation Center and Hainan Provincial Medical Products Administration to hold pilot drugs communication meetings, and providing full process tracking and guidance. Lecheng Pilot Zone Administration also provides active assistance in docking with medical institutions and patient recruitment. In addition, in the process of boosting the accelerated review of CoselaTM (trilaciclib）for injection, the expert team led by the president of the Hainan Real World Data Research Institute provided consulting services to the enterprise and guided the enterprise in the design and statistical analysis of real world research protocols.

"Thanks to the strong support and guidance of NMPA Drug Evaluation Center and Hainan Provincial Medical Products Administration, the real-time submission system is implemented for the pilot varieties of drugs. After a licensed medical drug or device is put into use, the enterprise can apply for the pilot varieties to the provincial administration and NMPA Drug Evaluation Center by formulating and submiting a perfect real-world research plan. On the basis of the previous coordination mechanism of the pilot real-world data application, this year, NMPA Drug Evaluation Center and the Hainan Provincial Medical Products Administration further improved the communication procedures for the pilot varieties and refined the guidance of application materials, and made it clear that there is no limit on the duration and number of communication meetings between NMPA Drug Evaluation Center and enterprises. These measures provide timely and efficient solutions to the problems encountered in the process of product registration by enterprises using Lecheng real-world data. " Fu Zhu, deputy director of Lecheng Pilot Zone Administration and vice president of Hainan Real World Data Research Institute, introduced.

The accelerated approval of pilot drugs by using Boao Lecheng’s clinical real-world data is of great significance to speed up the accessibility of global innovative drugs and devices in clinical use in China and better meet the people's demand for high-quality drugs and devices. Relying on the "fast lane" of Hainan's pilot work, eight international innovative medical products have been approved for marketing. Subsequently, Lecheng Pilot Zone Administration will, with the support of Hainan Provincial Medical Products Administration, healthcare authority, customs and other departments, deepen system integration and innovation, effectively solve the difficulties and problems encountered in the real-world data application pilot work, strive for more breakthrough results, and contribute "Hainan Power" to the reform of the national drug examination and approval system and benefit more Chinese patients.