cepharanthine is hot, and no clinical trial has been carried out at present
cepharanthine is hot, and no clinical trial has been carried out at present, and the concept of cepharanthine continues to be active, and then there are voices in the industry constantly questioning the statement that cepharanthine resists COVID-19. Stemonatin is hot, and clinical trials have not yet been carried out. Stemonatin is very popular, and clinical trials have not been carried out at present. 1
A few days ago, it was reported that a new drug for treating COVID-19 recently discovered by Chinese scientists was authorized by the national invention patent. This drug is Stemonatin, which claims to inhibit coronavirus replication by 15,393 times.
the popularity of cepharanthine has also led to the skyrocketing of Chinese medicine enterprises related to the domestic stock market, with multiple shares or even continuous daily limit, among which Bio-Valley has soared by 29.88% and nearly 4% in the past five trading days. Buchang Pharmaceutical (63858), Huabei Pharmaceutical (6812), Dali Pharmaceutical (63963) and Qianjin Pharmaceutical (6479) had daily limit, while Yunnan Baiyao (538) and Aladdin both hit daily limit, closing up 8.66% and 7.71% respectively.
Qianjin Pharmaceutical and Dali Pharmaceutical seem to be "unexpected" daily limit. Among them, Qianjin Pharmaceutical Co., Ltd. was hyped by funds because its name contained "Qianjin". The company recently said on the interactive platform that there were no related products of cepharanthine.
Dali Pharmaceutical Co., Ltd., a subsidiary of Yunnan Baiyao, collided with its name.
As for the popularity of cepharanthine, the patent inventor denied that it had anything to do with himself. "This matter has nothing to do with us."
It is reported that Tong Yigang, the inventor of cepharanthine-related patents and the president of beijing university of chemical technology College of Life Science and Technology, stressed in a live broadcast that cepharanthine was reported more than two years ago, but there was no response at that time. I didn't expect that this patent report caused such great concern, which may be related to the current epidemic situation. This is a coincidence, which led to the rise of some stocks.
Tong Yigang mentioned that at present, four enterprises with production batch numbers only have batch numbers, but they have not produced them, so it is impossible to buy this medicine in China. After this report attracted attention, some companies were interested in this, and some of the four companies with batch numbers found it.
Tong Yigang believes that there is no problem with the safety of Stephania Stephania Tablets. It is only necessary to make it effective. If we want to speed up the clinical trial, we should be able to go on the market with conditions soon. "I also hope that this day will come soon." Stemonatin is a hot topic, and clinical trials have not yet been carried out. 2
Recently, Science and Technology Daily reported that a new drug for treating COVID-19 discovered by scientists in China was granted a national invention patent. According to the above-mentioned report, from the current research data, the drug's ability to inhibit Covid-19 ranks among all Covid-19 inhibitors found in human beings.
The inventor of this patent is Professor Tong Yigang, Dean of beijing university of chemical technology College of Life Science and Technology. The patent specification shows that 1 μ m (micromole/L) of cepharanthine inhibits coronavirus replication by 15,393 times.
After the report was published, the concept of "cepharanthine" continued to be active. The daily limit of Yunnan Bio-Valley of Beijing Stock Exchange was up for two consecutive trading days, while Huabei Pharmaceutical, Buchang Pharmaceutical and Fangsheng Pharmaceutical were up, and Yunnan Baiyao opened 9.83% higher. Rheinland Bio also said on the interactive platform of Shenzhen Stock Exchange that at present, the company's products and processes do not cover the extraction of cepharanthine, but the company has technical reserves for the extraction of similar products. If there is a large demand for cepharanthine in the future, the company is confident to develop new technologies quickly and respond to market demand in time.
However, there have been many voices in the industry questioning the statement that "Stephania resisted COVID-19".
cepharanthine is a two-segment isovaline alkaloid isolated and extracted from Stephania cepharantha and Stephania japonica, which was previously approved for leukopenia. According to the National Medical Products Administration database, at present, four companies, namely, Shenyang Guancheng Pharmaceutical, Yunnan Bio-Valley Pharmaceutical, Wenshan Qihua Company of Yunnan Baiyao Group and Dali Pharmaceutical of Yunnan Baiyao Group, have the approval documents for Stephania.
In fact, there is no scientific basis for equating the above-mentioned patent authorization with cepharanthine as a new therapeutic drug in COVID-19.
Image source: beijing university of chemical technology WeChat WeChat official account
According to the patent specification, the patent name of the invention is "Chuanshanjia coronavirus xCoV and its application and application of drugs against coronavirus infection". Specifically, the inventor isolated and cultured a new coronavirus xCoV (not popular in Covid-19 since 22) from the dead onychomycosis which was seized by the customs, and called it xCoV.
the whole genome sequence analysis showed that the homology of S protein with SARS62COV622 (novel coronavirus) reached 92.5%, and it was the virus with the highest homology with the latter successfully isolated and cultured so far. The inventor used this xCoV to construct a model to screen and evaluate the active drugs and vaccines against Covid-19.
that is to say, the so-called cepharanthine can inhibit the virus in vitro, and it does not even inhibit Covid-19, but a kind of coronavirus with S protein expression similar to that of Covid-19.
The above patent specification shows that the inventors believe that cepharanthine is a promising candidate drug for treating Covid-19 infection. In the experiment of three screened effective compounds against Covid-19, cepharanthine, cilastatin and mefloquine hydrochloride, 1uM cepharanthine, cilastatin and mefloquine hydrochloride can inhibit virus replication by 15393 times, 553 times and 31 times respectively after 72 hours of cell infection, and the experimental results can be repeated.
Tong Yigang said in an interview with the media before that, generally speaking, the above data means that if cepharanthine is used, the number of viruses produced will be very small, which is only 15,393 times of the number of viruses without cepharanthine, that is, a small amount of cepharanthine can prevent Covid-19 from expanding and spreading, and can inhibit the new crown virus to a very low content.
However, similar to the old drugs such as Shuanghuanglian Oral Liquid and Abidor+Dalunavir, Tong Yigang's team has only done' in vitro experiments' on cepharanthine at the cell level.
Zhang Hongtao, a former associate professor of research at the University of Pennsylvania School of Medicine, told Interface News that the data of "inhibiting virus replication by 15,393 times" is not so important to some extent, because in vitro, for example, using alcohol can also reduce the virus by tens of thousands of times.
In addition, the above report also cited an article published in Science magazine in July 221. According to the article, American researchers put cepharanthine and 25 other candidate compounds together for comparative study. The results showed that the EC5 (concentration causing 5% maximum effect, the lower the number, the better) of cepharanthine against Covid-19 was only .1uM, which was far lower than other candidate drugs, including Remdesivir, which had been approved for marketing.
In this regard, Zhang Hongtao told Interface News that .1uM is a very important data, and it looks very good. But the most important thing is to go back to human trials to see if cepharanthine can achieve such an inhibitory effect in human trials. "It's like you can wipe out the virus with 7% alcohol, but you can't make the alcohol concentration in the blood reach 7% after drinking. Without this level, there is no way to achieve the effect of this drug. " Zhang Hongtao said.
This is commonly referred to as "blood drug concentration" in the research and development of new drugs. If the required blood drug concentration cannot be achieved under the premise of ensuring safety, it will not take effect.
In fact, as a "promising candidate drug", it is still a long way to go to say that cepharanthine is expected to be used to treat COVID-19.
As we all know, the research and development of new drugs need to go through three stages: drug discovery, preclinical research and clinical research including multi-phase trials, in order to confirm or discover the clinical, pharmacological and pharmacodynamic effects, adverse reactions, absorption, distribution, metabolism and excretion characteristics of experimental drugs, and to determine the safety and effectiveness of experimental drugs.
According to the data, in the research and development of new drugs, the median duration of clinical trials in the field of infection is 7.1 years, the success rate of new drug research and development is only 19.1%, and the pre-clinical in vitro implementation effect is excellent, but there are countless candidate drugs that failed in human clinical trials. From this perspective, there is nothing special about cepharanthine.
Zhang Hongtao further indicated that even with some preliminary data of animal experiments, it may be easier to judge the effect of cepharanthine in human body. As far as the current research progress is concerned, there are still many unknown factors, and there is still a long way to go before the real patent medicine is approved and listed. In addition, he also pointed out that there may be speculation about cepharanthine at present, such as directly buying plants containing cepharanthine to eat, so as to prevent COVID-19, which is "jumping and unfeasible". Stemonatin is hot, and clinical trials have not yet been carried out. 3
At the moment when the epidemic situation in COVID-19 is repeated, the research and development progress of related drugs has always been a hot spot pursued by the capital market.
According to media reports, recently, the team of Professor Tong Yigang, Dean of beijing university of chemical technology College of Life Science and Technology, discovered a new drug for treating COVID-19, which was authorized by the national invention patent. According to the patent specification, 1μ m (micromole/L) of cepharanthine inhibited the replication of coronavirus by 15,393 times.
According to public information, cepharanthine (CEP) is a natural alkaloid extracted from plants. At present, its Chinese patent medicine has been listed in China and abroad, and it has been clinically used for more than 4 years. According to the information inquired on the website of National Medical Products Administration, four listed companies, including Yunnan Bio-Valley Pharmaceutical Co., Ltd. and Yunnan Baiyao Co., Ltd., have the approval number of Stephania.
Putting on the anti-COVID-19 concept of "cepharanthine" has ignited the share prices of many listed companies. On May 16th, Bio-Valley, Unionway, Dali Pharmaceutical, Buchang Pharmaceutical, Huabei Pharmaceutical, Qianjin Pharmaceutical and other stocks staged daily limit, while Yunnan Baiyao and Rheinland Bio once rose and then fell back.
A number of companies responded
National Medical Products Administration official website showed that Dali Pharmaceutical Co., Ltd. and Wenshan Qihua Co., Ltd., subsidiaries of Yunnan Baiyao Group, obtained the approval number of cepharanthine tablets. In response to the research and development progress of Stephania against COVID-19, a person from Yunnan Baiyao's Secretary-General's Office told reporters that the company has paid attention to this matter and will reply as soon as possible through the investor interaction platform.
In addition, many listed companies sent positive messages about the production of cepharanthine. On May 16th, in response to an investor's question, You Ningwei said that cepharanthine, as a biochemical reagent, was used in the research stage, and at present, the sales volume of this product contributed little to the company.
On the same day, Rheinland Bio said on the interactive platform that cepharanthine belongs to alkaloids, and the company has technical reserves for extracting similar products. If there is a large demand for cepharanthine in the future, the company is confident to quickly develop new technology and respond to market demand in a timely manner with years of experience in plant extraction and technical accumulation of similar products.
In addition, some investors have asked the listed companies about the stock situation of cepharanthine. Luyan Medicine told investors that the company will stock up according to the actual needs of the business.
Affected by this news, the share prices of many listed companies rose sharply. On May 16th, the daily limit of Bio-Valley and Unionway increased, among which Bio-Valley rose by 3% for two consecutive trading days, which attracted attention.
However, according to the reporter, among the listed companies with the above daily limit, Dali Pharmaceutical and Qianjin Pharmaceutical have no cepharanthine-related business.
in response to investors' questions, Qianjin Pharmaceutical said that the main component of Fuke Qianjin Tablet is FibraurearecisaPierre, an alkaloid extracted from the dried rattan of Stephania tetrandra. Stephanin is a two-segment isovaline alkaloid isolated and extracted from Stephania cepharantha and Stephania scoparia of Menispermaceae. They are not the same substance, and there are great differences in chemical structure and pharmacological action.
Buchang Pharmaceutical announced on the evening of May 16th that Shandong Danhong Pharmaceutical Co., Ltd. (formerly Heze Buchang Pharmaceutical Co., Ltd.), a wholly-owned subsidiary of the company, has an invention patent for "a preparation method of cepharanthine hydrochloride [patent number: ZL211556531.]", and the company has no R&D, production and sales of cepharanthine related products at present.
On the evening of May 16th, Huabei Pharmaceutical announced that at present, the company has not carried out technical cooperation with related expert teams and has no related products of cepharanthine.
Investors should "invest cautiously"
According to media reports, a Canadian pharmaceutical company has contacted the US FDA to conduct a clinical trial study on the treatment of cepharanthine in COVID-19, which is expected to be officially launched in the second half of this year. In addition, Professor Tong Yigang recently posted on social platforms that it will take some time for new drugs to reach the clinic and go on the market.
A person from the Secretary-General's Office of a pharmaceutical listed company told the Securities Daily reporter that "from the patent acquisition situation, the above information has certain authority". However, it should be pointed out that the above research has not yet entered the clinic, which also means that it will take some time for cepharanthine to be used to inhibit Covid-19.
In addition, Yin Baoqing, deputy general manager of Senrui Fund, said in an interview with Securities Daily that Stephania has just gone through the stage of drug discovery in essence, and then it has to go through the steps of pharmacokinetics, pharmacology, toxicology, cmc, etc. before it can be declared for clinical use, and it can only be declared for listing after it has been approved, and all the above steps may fail. If the final research and development is successful, we should also pay attention to the epidemic situation and demand of COVID-19 after listing, which are unknown at present.
"COVID-19's concept of listed companies is a hot spot in the capital market, but we should also pay attention to the risk of following suit." An investor told this reporter.