Press conference on the role of scientific and technological innovation in supporting epidemic prevention and control
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E-mail China.org.cn, February 22, 2020
Bloomberg:
I have two questions. Why was it decided that the clinical diagnosis category for new infections was no longer needed for Hubei province? Does that mean that all new cases of infection in Hubei were confirmed using nucleic acid tests? And, after removing the clinical diagnosis category, why did the number of new cases decrease so much from almost 1,700 on Feb. 18 to 349 on Feb. 19? Thank you. And my second question is what kind of progress are you having with trials of new treatment and drugs for the coronavirus? There was some initial success with Gilead's Remdesivir. Is there any progress with that drug? And if there is, what might the next step be? Thank you very much.
Zeng Yixin:
Thanks for your question. I can see that you have a strong concern about diagnosis of the epidemic. Regarding your question, Mr. Wang Guiqiang, director of Infectious Disease Department of Peking University's No. 1 Hospital, has made a thorough explanation at the joint prevention and control mechanism briefing yesterday. Let me ask you to refer to that answer. Thank you.
Xu Nanping:
Thanks for your question. Regarding the research and development of medicines, it is something that the public and the media are following very closely. I would like to cover this question from two aspects. First is the overall situation of medicine research and development. We all know that medicine R&D involves a lot of time, but the situation is pressing under the present circumstances. Still, we must insist on the principle of "safety, effectiveness and guaranteed supply." We are making selections from the existing drugs already circulating or undergoing clinical trials, while ensuring drug safety. The question actually has something to do with drug supply. A drug is not helpful if it cannot be put into full production, no matter how good is has been proven to be. So, our medicine R&D will strictly follow the principle that I've mentioned.
A new drug has to go through five stages before it can be used to treat the virus: Phase one is primary screening. Experts, based on their experience as well as relevant pharmaceutical theories and methods, will propose and screen some drugs that might be effective for tackling the virus. Phase two involves in-vitro experiments. We will conduct anti-viral experiments in vitro to confirm whether the medicine can be effective. If these experiments confirm effectiveness, we will carry out small-scale clinical research in phase three to further test safety and effectiveness. If phase three is successful, we will conduct large-scale clinical trials for further confirmation. For the medicine with positive trial results, through certain procedures, we will recommend it be included in treatment protocols.
What I am introducing to you today is the latest progress being made. At the previous press conference, the Ministry of Science and Technology introduced the "three medicines and three therapy plans". Three medicines have been included in the COVID-19 diagnosis and treatment scheme, indicating that doctors have an option to use these medicines. The first is the traditional Chinese medicine (TCM) which was included in the 3rd edition of the diagnosis and treatment scheme, then improved in the fourth, fifth, and sixth editions. Now, it looks to be having very good effect. TCM has been used in the treatment for more than 60,000 confirmed cases accounting for more than 85% of the national total. In general, the TCM treatment has certain effects, and the combination of traditional Chinese and Western medicine has proved to be very effective.
The second is chloroquine phosphate, which has already come to market. After five stages of research, it was tested in 135 cases in Beijing and Guangdong province. There is a phenomenon worthy of our attention: in the treatments of 130 patients with light and ordinary symptoms; so far, we found no case has changed from showing light or ordinary symptoms to developing severe ones. The other five patients with severe symptoms were treated, among whom four were discharged, and one was identified as ordinary status. Generally speaking, the effect is good. Now, chloroquine phosphate has been included in the 6th edition of the COVID-19 diagnosis and treatment scheme. We hope to further summarize the efficacy on the basis of larger-scale application.
The third is the therapy of convalescent plasma, which was included in the fifth edition of the COVID-19 diagnosis and treatment scheme, and in the sixth edition, it further clarifies that the therapy is suitable for patients with rapid disease progression, as well as severely and critically ill patients.
Another three medicines are undergoing clinical trials. The first is favipiravir. Eighty controlled trials have been conducted in Shenzhen. According to current observations, the effects are good. Experts suggest that the trials be further expanded to examine the treatment effect on patients. The second is stem cell therapy. Four patients with severe symptoms have been discharged after receiving such treatment, and clinical trials will be expanded. The third is remdesivir, as just mentioned by the reporter. In-vitro tests performed by scientists have shown good inhibitory effect on the virus. We contacted Gilead through relevant institutions, and now there are 10 hospitals in Wuhan participating in clinical trials. More than 200 severely and critically ill patients are now enrolled in the trials, and more than 30 patients with mild symptoms and ordinary patients as well. So, if you want to ask the result, I am, just like everyone, looking forward to it very much. Since it is a double-blind clinical trial, I know just as much as everyone else. Just now, the reporter also asked, if the effect is good, what will we do? We have always maintained good communication with Gilead. If the effect is good, we will work with Gilead to find out an appropriate method of medicine supply with top priority given to the people's interests. Thank you.
Chen Shifei:
Thanks for the questions from the foreign reporter. I will answer the question about the progress of emergency drug approval of the National Medical Products Administration (NMPA). Since the outbreak, the NMPA has resolutely implemented the decisions and arrangements of the CPC Central Committee and the State Council, and carried out scientific, orderly and precise emergency approval work of drugs for prevention and control of the novel coronavirus pneumonia. First, the emergency review and approval mechanism was initiated in accordance with the law, and an expert team with academicians as its core was established. The expert team includes well-known domestic experts from various aspects of pharmacy, pharmacology, toxicology, and clinical practice. We have decided the working principles of unified command, early intervention, review upon arrival, and scientific approval. Second, we quickly convened forces of review experts to formulate technical guidelines for the development of anti-COVID-19 drugs and requirements for safe and effective drug development. We actively connect with and serve the medicine research and development entities to help accelerate and improve the drug research and development.
Third, we firmly take the safety and effectiveness of drugs as the fundamental. And we must respect science. At the same time, we must create innovative methods of review and approval. For drugs of high maturity and drugs with a solid foundation of previous development works, we have conducted parallel review and examination, inspection and test, and fast-track approval, providing drug guarantee for the prevention, control and treatment of COVID-19.
The data from clinical treatment has revealed that many safe and effective chemical medicines and traditional Chinese medicines have been listed in the frontline medical treatment plan against the epidemic. These include both widely prescribed pharmaceuticals prepared and used by medical organizations and several anti-viral chemical medicines and Chinese patent medicines that have been approved by the National Medical Products Administration to hit the market. It is known that over 80 traditional Chinese medicines have been prescribed in the epidemic treatment so far. These have been proved effective in the medical practice.
Besides, we gave clinical trial permissions to five new medicines to treat COVID-19. All of them were approved in accordance with safety requirements and proved effective in dealing with various cases, and they were all quality guaranteed and were provided with accelerated approval procedures. These trials have been well processed now. There are also medicines that were used in non-COVID-19 indications applied to the program of achieving a breakthrough in our research. Some of them have completed the research phase, so we put them into a prioritized group for examination and approval procedures. We have speeded up the permission work to ensure their safe availability for frontline clinical treatment solutions.
The National Medical Products Administration attaches great importance to research and development of vaccines. We set up a group with specialists and assigned them with different scientific research groups to carry forward the key vaccine projects. During this special period, the evaluation team is providing direct instructions to help with and follow up the research and development progress. For medicines and vaccines that are safe and quality controllable, the National Medical Products Administration will work against time to complete the evaluation and authorize them immediately for fighting COVID-19. I want to emphasize that we pay great attention to quality management of the clinical trials and we make any efforts to protect those patients' rights. We want to guarantee that results of the trials are accurate and reliable. We also reinforce supervision on the medicines and medical devices for epidemic prevention and control, crackdown on illegal activities of selling fake products and ensure the medical products' safety and quality.
For the next step, the National Medical Products Administration will continue to closely trace the development of the epidemic and follow the requirements of its prevention and control. We will also conduct a follow-up of developments in new scientific researches and get prepared for examination and approval procedures of the prioritized programs. And we will try our best to win this battle against the epidemic. Thank you.
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