6 Products! Another international innovative drug approved for marketing under the Lecheng real-world data application project

Updated: August 2, 2022 L M S

A drug called "Fluocinolone Acetonide Intravitreal Implant" is like a warm light, illuminating the gloomy life of Mr. Chen, a patient with chronic non-infectious uveitis.

Not long ago, the fluocinolone acetonide intravitreal implant was approved for marketing based on overseas clinical trial data and Lecheng clinical real-world data. Mr. Chen, who has been suffering from vision loss for a long time, took the drug in the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Lecheng Pilot Zone), and recovered his eyesight significantly.

It is reported that 6 products have been approved for marketing in Lecheng Pilot Zone by using the real-world evidence of Lecheng to support clinical evaluation, and 3 products are under the application process through the real-world data pilot application channel. Driven by multiple favorable policies and system integration innovation, Lecheng Pilot Zone has become the most important channel for international innovative drugs and devices to enter China.

"Thanks to the convenience brought by the system integration and innovation of Hainan Free Trade Port and the strong support of the National Medical Products Administration, Lecheng Pilot Zone Administration has organized a series of real-world data research projects, built a real-world data platform in Hainan Province, and developed tools to improve the quality and collection efficiency of real-world data, and help pharmaceutical companies conduct real-world research in a convenient and efficient manner." Fu Zhu, Deputy Director of Lecheng Pilot Zone Administration and Vice President of Hainan Real World Data Research Institute, introduced.

Chen Donghong, Chief Medical Officer of Ocumension Therapeutics Co., Ltd., was deeply touched when talking about the fact that the fluocinolone acetonide intravitreal implant was approved for marketing under the Lecheng real-world pilot research project. "From the drafting of the plan and data collection to product testing and submission of registration applications, Ocumension has got a lot of help," Chen Donghong told the Hainan Daily reporter, "With the assistance of Lecheng Pilot Zone Administration communications and coordination, and the full-process follow-up by NMPA Drug Evaluation Center and Hainan Provincial Medical Products Administration, they provided the whole process tracking and guidance for the registration of the drug."

Fu Zhu introduced, "On the basis of the pilot service guidelines for real-world research on drugs and devices, we have also launched a working mechanism for coordination of real-world data research, and developed communication procedures for pilot varieties of clinical real-world data applications for drugs and devices to further clarify the submission requirements and communication mechanisms to achieve normalized submission and dynamic management." The thoughtful service of "there is no limit on time and frequency for the communication meeting between enterprises and HMPA Drug Evaluation Center" provides a good way for enterprises to solve problems one on one and face to face.

"Up to now, we have submitted 3 applications for real-world data research projects for innovative products, 2 of which have been approved for marketing." Xu Ping, vice president of Boston Scientific China, said that the company started clinical real-world research for its Rezum water vapor thermal therapy device and disposable prostate water vapor therapy device at the medical institution in the Lecheng Pilot Zone in July last year, and submitted an application for marketing late October of that year. The application was approved through Lecheng Real World Research in March this year, so it can serve more patients.

At the same time, attracted by the real-world research of Lecheng, many well-known pharmaceutical companies in the world have held out an olive branch to Lecheng. "At present, the world's top pharmaceutical companies such as Boston Scientific, Novartis, and Sanofi have set up their real-world data research centers in the zone to seize real-world research opportunities at Lecheng." Jia Ning, Director of Lecheng Pilot Zone Administration, said.

"Lecheng Pilot Zone actively promotes real-world research, providing 'Lecheng’s Practice' and 'Hainan’s Experience' for the reform of the national drug device review and approval system." Jia Ning said that in the next step, Lecheng Pilot Zone would promote the use of foreign innovative drugs and devices in the fields of oncology, cardiovascular diseases, neurology, etc., and strengthen the development of real-world research, so as to facilitate the launch of more innovative drugs and devices urgently needed by Chinese patients in China and accelerate the development of Lecheng Pilot Zone into a highland for the integration of clinical research and real-world research.