Over 60% of 73 new overseas new drugs in urgent clinical need have been approved in China
The State Food and Drug Administration and the National Health and Medical Commission have released three batches of lists of overseas new drugs urgently needed for clinical use, and the treatment fields of metabolic and tumor diseases are relatively concentrated
In order to speed up the entry of overseas new drugs urgently needed for clinical use into my country, since 2018, the State Food and Drug Administration and the National Health and Health Commission have successively announced three batches of lists of overseas new drugs urgently needed in clinical practice, involving 73 drugs.
A reporter from the Beijing News sorted out the data based on the Dingxiangyuan Insight database and public information and found that in the three batches of lists, 46 drugs have been approved in China, and metabolic diseases, tumors, and immune system diseases are relatively concentrated treatment areas.
Over 60% of the "listed" drugs have been approved in China
Since November 2018, the State Food and Drug Administration and the National Health and Health Commission have successively released three batches of lists of overseas new drugs urgently needed for clinical use, covering 40, 26, and 7 drugs, totaling 73 types.
According to the Lilac Garden Insight database and public information, reporters from the Beijing News sorted out 73 drugs in the list.
As of April 19, 46 drugs on the list have been approved in China, accounting for 63.01% of the approved drugs, and some drugs have not yet been submitted for marketing applications in China.
As early as when the first batch of the list was released, the Center for Drug Evaluation of the State Food and Drug Administration stated that the varieties included in the list of overseas new drugs urgently needed for clinical use can submit relevant materials in accordance with the "Working Procedures for the Review and Approval of Overseas New Drugs in Urgent Clinical Need" and submit a marketing application directly. , the center established a special channel to speed up the review.
For varieties that have not yet been declared, you can communicate with the center at any time and submit a listing application as soon as possible.
According to a CCTV report, in the review of some anti-tumor drugs that are urgently needed in clinical practice, the Drug Evaluation Center will intervene in the drug development process in advance, communicate in advance, and work with R&D scientists and applicants to jointly agree on a global synchronized R&D strategy. So that the products can be quickly integrated with foreign countries and listed in China at the same time.
When the third batch of lists was released in November 2020, the Center for Drug Evaluation of the State Food and Drug Administration also stated that for the varieties that meet the requirements of the "Announcement on Matters Related to the Review and Approval of Overseas New Drugs Urgently Needed in Clinical", the State Food and Drug Administration, in conjunction with the National The Health Commission has organized a full selection, which basically solved the historical problem of the slow listing of new drugs that are urgently needed for overseas marketing in my country. With the deepening of the review and approval system reform, the ICH (International Council for Harmonization of Human Drug Registration Technology) guidelines my country has gradually established a regulatory system for the simultaneous R&D and declaration of overseas new drugs in China, and encourages the simultaneous R&D and declaration of overseas new drugs in China.
The therapeutic areas of metabolism, oncology, and immune diseases are relatively concentrated
The drug treatment fields involved in the three batches of overseas new drug lists are relatively concentrated.
Among them, the indications of 14 drugs involve metabolic diseases, such as Fabry disease, IVA type mucopolysaccharidosis and other rare diseases; the indications of 10 drugs cover the immune system and tumors.
In the classification of all therapeutic areas, the number of drugs involved in these three therapeutic areas accounted for 39.53%.
Drug indications involve more therapeutic areas, including endocrine system, skin diseases, nervous system, cardiovascular and cerebrovascular diseases, blood system diseases, and infectious diseases.
There are also 5 drugs for the indication of psoriatic arthritis, namely brolimumab from Concord Kirin, secukinumab from Novartis, ixekizumab from Eli Lilly, and Celgene Pharma. Apremilast and Janssen Biotech's guselkumab.
Hepatitis C is also a common indication for the drugs on the list. Among the 5 drugs involved in infectious diseases, 3 indications are hepatitis C, of which 2 are from Gilead and 1 is AbbVie's drug.
In addition to the classification of disease treatment areas, rare diseases have become the highest proportion of drugs.
Among the 73 drugs listed in the three batches, 37 are rare disease drugs, accounting for 50.68%.
Among the 46 approved drugs, 21 are rare disease drugs, accounting for 45.65%.
One of the 73 drugs is a vaccine product, the recombinant shingles vaccine under GlaxoSmithKline, which was approved in China in June 2020 and is suitable for adults aged 50 and over to prevent shingles.
According to public information, there are about 1.56 million new cases of herpes zoster every year among people aged 50 and over in my country.
More than 99 percent of people age 50 and older have been infected with the varicella-zoster virus, and about one-third will develop shingles in their lifetime.
Chang Xiao, director of the Department of Dermatology of Xuanwu Hospital of Capital Medical University, said in an interview with the Beijing News that in terms of clinical costs, herpes zoster is a relatively expensive disease in dermatology, although medical insurance can cover the current treatment drugs for the disease, but The patient's own cost is also relatively high, and it will consume a certain amount of medical insurance resources. Not only that, but these patients still "occupy" medical resources. "A mild herpes zoster patient, in addition to the current medical treatment, also needs to Two follow-up visits. If the patient has postherpetic neuralgia, the number of follow-up visits will actually be more. If the patient has postherpetic neuralgia, he has to take analgesic drugs for a long time.”
Clobazam plans to temporarily import the drug shortage dilemma is expected to ease
In addition to the list of three batches of overseas new drugs urgently needed for clinical use, clobazam has also attracted widespread attention.
In fact, as early as May 2017, clobazam was included in the "Second Batch of Recommended List of Children's Drugs Encouraged for R&D and Application" as "an unregistered and urgently needed clinical drug for children in mainland China".
Clobazam is a very effective broad-spectrum anti-seizure drug for the treatment of rare epileptic encephalopathy, which can effectively control seizures.
The drug was first listed in the Philippines in 1967, and was subsequently launched in the United States, Britain, France, Germany and other countries.
However, the drug belongs to the second category of psychotropic drugs in my country and has not been approved.
Earlier, clobazam has been discussed many times on the Chinese Internet.
The focus is that the "100 Narcotic Drugs and Psychotropic Substances Dependence Conversion Table" issued by the National Narcotics Control Commission states that "1 gram of clobazam is equivalent to 0.1 mg of heroin", and many voices believe that clobazam is heroin. alternatives.
Wang Xuefeng, executive director of the China Anti-epilepsy Association and chairman of the Drug Treatment Committee, once said that clobazam and heroin are far different in composition, "Heroin excites people, and clobazam can inhibit abnormal mental activities. The person's mental state is already normal, so taking clobazam will have little effect."
Although doctors will write clobazam in the prescription, there is no formal way for parents of children in China to buy it, and some parents have to seek "life-saving medicine" for their children through overseas shopping or purchasing.
On March 29, the official website of the National Health and Medical Commission issued an announcement to solicit public comments on the "Work Plan for Temporary Import of Drugs Urgently Needed in Clinical" and "Work Plan for Temporary Import of Clobazam" to meet the urgent need for clinical medication.
The draft for comments shows that the National Health and Health Commission will organize to propose the clinical demand for clobazam, determine the list of medical institutions that use it, select the medical institutions that will lead the import, organize the formulation of drug use specifications and prescription qualification requirements, and clarify the informed consent of patients and the exemption of doctors. Require.
The medical institution leading the import shall file a temporary import application with the State Food and Drug Administration and submit relevant materials.
At the same time, the medical institution leading the import may entrust the import unit to apply for the import permit.
The importing unit shall submit an application for an import license in accordance with the guidelines for the approval of the import of narcotic drugs and psychotropic drugs for clinical use published by the online office of the State Food and Drug Administration.
The importing unit shall go through the customs clearance formalities directly with the customs with the import permit.
Such imported drugs do not need to undergo port inspection.
Beijing News reporter Zhang Xiulan Wang Kara