China News Network Haikou, June 9 (Reporter Zhang Qianyi) The reporter learned from the press conference held on the 9th that Hainan Free Trade Port Key Park and Boao Lecheng International Medical Tourism Pioneer Zone (hereinafter referred to as "Lecheng Pioneer Zone") import The first batch of licensed medical equipment varieties exceeded 100 cases and 100 new anti-tumor drugs and rare disease drugs were available.
It is understood that the imported licensed medical devices, new anti-tumor drugs, and rare disease drugs introduced in the Lecheng Pioneer District are provided by approximately 40 well-known multinational pharmaceutical device companies such as Johnson & Johnson, Medtronic, Boston Scientific, and Merck.
Gu Gang, director of the Lecheng Pioneer District Administration, said that the Pioneer District has gradually established departments such as ophthalmology, cardiovascular, medical beauty, otolaryngology, orthopedics, and rehabilitation medicine. These departments will become more and more people come to the clinic for treatment Sick new destination.
Gu Gang gave an example. In the leading area of Lecheng, ophthalmology has had 18 new products and medical equipment that can be used for diagnosis and treatment from 0 to now. The vast majority of these 18 products are not listed in China. For example, Boston artificial cornea was listed in the United States in 1992, but because it is relatively niche, it has never applied for registration in China, so patients in China have no way to enjoy this artificial cornea. technology. Because of the Lecheng Pioneer District Concession Policy, 37 patients are now seeing light in the Lecheng Pioneer District, and most patients are blind for more than 15 to 20 years.
Gu Gang said that over 50 new oncology drugs introduced in the Lecheng Pioneer Area come from 22 manufacturers, corresponding to 70 oncology diseases, all of which are new drugs that have not yet been marketed in China. Although 14 of them are already on the market in China, they have not released all indications. In the Lecheng Pioneer Area, in addition to the domestically approved indications, doctors prescribe them for use within the scope of drug treatment indications.
According to reports, the first batch of rare disease medicines introduced in the Lecheng Pioneer District has a total of 48 kinds, from manufacturers in more than 10 different countries. Gu Gang, for example, in the list of rare disease drugs introduced this time, "Dazeyou" provided by Takeda Pharmaceuticals, Japan, is suitable for patients 12 years of age and older to prevent the onset of hereditary angioedema (HAE). Hereditary angioedema is a primary complement deficiency disease characterized by episodic, self-limiting, and localized non-recessed edema under the skin and mucosa of the whole body. The incidence rate in China is one in 50,000. Mainly manifested as recurrent swelling of the skin, respiratory tract and internal organs. When edema occurs in the airway, it can cause laryngeal edema. If the rescue is not timely, it can be suffocated. The introduction of "Dazeyou" in the Pioneer District of Lecheng can relieve these families of huge mental burdens and save more people's lives in time.
Gu Gang said that a drug from the R&D to the third-phase clinical, so as to successfully market, the success rate is only about 0.1%, and it takes up to 5-10 years. Even if it is calculated from the registration, it takes an average of 3-5 years. Of the 100 innovative medical devices and 100 new drugs for tumors and rare diseases introduced in Lecheng Pioneer District this time, 11 cases were listed in foreign countries within one year and were applied in the Pioneer District. For example, the licensed drug YUTIQ (Fluorine Relaxant Intravitreal Implant) currently being used in the Lecheng Pioneer District. This product has been used in the Pioneer District less than a year after it was marketed abroad, and has cured more than 10 patients.
The reporter learned from the press conference that Lecheng Pioneer District has highlighted the characteristics of medical examination and approval in the reform of "minimum approval" and paid more attention to the convenience of using medical equipment. At present, a chartered management platform for licensed medical devices has been established, which has changed the paper approval of medical devices into online approval, simplifying the approval process. The Hainan Provincial Food and Drug Administration has shortened the time limit for the approval of medical equipment from 27 days to 3-7 days; the Hainan Provincial Health and Health Commission has specially established a working mechanism for the Lecheng Pioneer District. It has become a routine operation to handle all the approval matters in one working day; The pioneer zone is regarded as a special supervision zone separately, and an innovative supervision model of “into the warehouse and inspection later” is implemented.
Zhu Ning, deputy director of the Hainan Provincial Food and Drug Administration, said that in the next step, the Hainan Provincial Food and Drug Administration will continue to promote the pilot application of clinical real-world data in the Lecheng Pioneer District, and launch the second batch on the basis of the first batch of medical device pilot varieties Pilots to study varieties, while exploring pilot projects for real-world data application of clinical drugs, further improve the regulatory supporting system, achieve regulatory capacity and level improvement, and ensure the quality and safety of clinically urgently needed imported medical equipment. (Finish)