Recently, 5-Aminolevulinic Acid Hexyl Ester Hydrochloride injection produced by Photocure ASA Company has been included among the pilot drugs, making the number of pilot drugs in Lecheng’s real-world data application increase to nine.

The aforesaid injection is a photosensitizer used as an auxiliary drug for the bladder cancer diagnosis or surgery, which was respectively approved to be marketed in the EU and the US in March 2005 and May 2010 and was approved to be used in the Lecheng branch of Hainan General Hospital as an imported drug for urgent clinical needs in August 2021.

The real-world data application piloting program was a major institutional innovation of Hainan in the medical field as well as an important exploration in the national reform of medical product review and approval system.

It was reported that to normalize this pilot program in Lecheng, the NMPA Center for Drug Evaluation, the Lecheng Administration and the HMPA established a three-party coordination mechanism. Since the mechanism was put into operation, the three parties have held coordination meetings and exchanged views on the pilot medical products, which ensured that the pilot program was advancing smoothly.

With concrete and effective results, the pilot program has promoted the internationally innovative medical products to be marketed within Chinese border and allowed Chinese patients to access internationally leading medical resources at a faster pace. In the future, Lecheng will continue to promote the pilot program, attract more pharmaceutical companies at home and abroad to be actively involved, and further accelerate the introduction of globally innovative medical products, so as to better satisfy the people’s health demands.