New achievement made by Lecheng from the pilot application of the Real World Data! The marketing authorization application of Trilaciclib for injection accepted by the National Medical Products Administration

Updated: December 14, 2021 L M S

On November 29, 2021, NMPA accepted a NDA for Trilaciclib submitted by Simcere, an overseas drug intended for preventive use in patients with extensive-stage small cell lung cancer (ES-SCLC) who are going to receive platinum-containing drug combined with etoposide regimen, so as to reduce the incidence of myelosuppression caused by chemotherapy, marking a new achievement made by Lecheng from the pilot application of real world data.

On May 18, 2021, Simcere submitted an application and plan for the pilot implementation of real world research to Hainan Medical Products Administration (Hainan MPA). On July 16, 2021, NMPA’s Center for Drug Evaluation organized a meeting to communicate with Simcere’s research team. On August 16, 2021, Hainan MPA, according to the opinion of the Center for Drug Evaluation, agreed that Trilaciclib for injection submitted by Simcere be used as a trial drug for Lecheng to implement the clinical real-world data application. Trilaciclib was approved to be launched in the United States on February 13th, 2021. As a product intended to preventively preserve bone marrow and immune system function during chemotherapy, clinical studies have demonstrated that its application can reduce the side effects and complications caused by bone marrow suppression in patients with extensive-stage small cell lung cancer, which can protect bone marrow. It received FDA Priority Review and Breakthrough Therapy Designation.

With the joint support of the Health Commission of Hainan Province, Hainan MPA and Lecheng Pilot Zone Administration, and with the “Try First” policy granted to Lecheng Pilot Zone, the world’s first prescription of Trilaciclib was issued on June 2, 2021 in Boao Lecheng Pilot Zone except the approving country (United States), which was first used for clinical treatment of patients with extensive-stage small cell lung cancer in China, and then started the real world research. Compared with traditional clinical research, the real-world research incorporates more complicated disease states, more diversified treatment schemes and more flexible treatment opportunities, which more comprehensively reflects the real data of Trilaciclib in the Chinese population. The NDA for Trilaciclib submitted by Simcere used the data of the real world research conducted in Lecheng as important supporting evidence, which reflected the efficacy and safety of Trilacicilib in Chinese population under real diagnosis and treatment. NMPA’s acceptance of the NDA for this product is another new achievement made by Lecheng in deepening the pilot application of real-world data. As a “experimental field” for China's medical reform and opening up, Lecheng Pilot Zone, with the strong support and guidance of the NMPA and Hainan MPA, takes the lead in carrying out the pilot work of clinical real-world data application, and strived to explore new tools, new standards and new methods that can be replicated and promoted for the reform of the national medical drug and device review and approval system. At present, Lecheng’s drug real-world pilot work has entered a new normal that application is submitted immediately after the drug become matured, established a coordination mechanism, initially established a preliminary examination mechanism for the real-world drug research pilot program, a communication and coordination mechanism with enterprises, and explored the methods and standards for on-site inspection. Lecheng Pilot Zone Administration and Hainan MPA will take people as the center, continue to actively explore the application of clinical real-world data in the registration and regulatory decision-making for pharmaceutical and medical device products, and continue to explore experiences for the reform of national pharmaceutical and medical device review and approval system, so as to better meet the people's health needs.