Stephanotis is very popular, but no clinical trials have been carried out yet
Stephanotis is very popular, and no clinical trials have been carried out yet. The concept of "Stephanotis" continues to be active, and subsequently it has become popular in the industry. There are constant voices raising many doubts about the statement that "Stephanotis is anti-coronavirus". Stephanatine is very popular, but no clinical trials have been carried out yet. Stephanotis is very popular, but no clinical trials have been carried out yet 1
A few days ago, it was reported that a new drug for the treatment of COVID-19 recently discovered by Chinese scientists has been authorized by the national invention patent. This drug is Stephanatine, which is claimed to inhibit the coronavirus. The multiple of replication is 15393 times.
The popularity of Stephanotis has also led to a surge in related traditional Chinese medicine companies in the domestic stock market, with many stocks even hitting daily limits. Among them, Biological Valley has soared 29.88%, rising by nearly 40% in the past five trading days. Buchang Pharmaceutical (603858), North China Pharmaceutical (600812), Dali Pharmaceutical (603963), and Qianjin Pharmaceutical (600479) reached their daily limit. Yunnan Baiyao (000538) and Aladdin both hit their daily limit during the session, closing up 8.66% and 7.71 respectively. %.
Qianjin Pharmaceutical and Dali Pharmaceutical seem to have "unexpectedly" reached their daily limit. Among them, Qianjin Pharmaceutical has been speculated by funds because its name contains "Qianjin". The company recently stated on the interactive platform that it does not have any products related to stepheniocin.
Dali Pharmaceutical has a name conflict with Dali Pharmaceutical Co., Ltd., a subsidiary of Yunnan Baiyao.
Regarding the popularity of Stephanotis, the inventor of the patent denies that it has anything to do with him. "This matter has nothing to do with us."
According to reports, regarding this secondary market carnival brought about by stephanotisin, the inventor of stephanotisin-related patents, School of Life Sciences and Technology, Beijing University of Chemical Technology Dean Tong Yigang emphasized in a live broadcast that the report of Stephania vines was published more than two years ago. At that time, there was no response. He did not expect that the report of the patent would attract so much attention, which may be related to the current epidemic situation. This is a coincidence, causing some stocks to rise even more unexpectedly.
Tong Yigang mentioned that the four companies that currently have production batch numbers only have batch numbers but do not produce them. This medicine is not available in China. After this report attracted attention, some companies became more interested in this matter, and some of the four companies with batch numbers also approached them.
Tong Yigang believes that there is no problem with the safety of Stephanotis Tablets. All we need to do is to prove its effectiveness. If we want to speed up clinical trials, it should be marketed relatively quickly with conditions. “I also hope that This day will come soon." Stephanotis is very popular, but no clinical trials have been carried out yet2
"Science and Technology Daily" recently reported that the new drug for the treatment of COVID-19 discovered by Chinese scientists has been authorized by the national invention patent. According to the above report, based on current research data, the drug’s ability to inhibit the new coronavirus ranks high among all new coronavirus inhibitors discovered by humans.
The inventors of this patent are the team of Professor Tong Yigang, Dean of the School of Life Sciences and Technology, Beijing University of Chemical Technology. The patent specification shows that 10uM (micromol/L) stephanatine inhibits coronavirus replication by 15,393 times.
After the release of the report, the concept of "Stephenia cerevisiae" continued to be active. Yunnan Bio Valley on the Beijing Stock Exchange has hit the daily limit for two consecutive trading days, North China Pharmaceutical, Buchang Pharmaceutical, and Fangsheng Pharmaceutical have hit the daily limit, and Yunnan Baiyao opened 9.83% higher. Rhine Biotechnology also stated on the Shenzhen Stock Exchange Yi Interactive Platform that the company’s products and processes currently do not cover the extraction of stephanatine, but the company has extraction technology reserves for similar products. If there is a large demand in the stephanotisin market in the future, the company is confident to quickly carry out new technology research and development and respond to market demand in a timely manner.
However, subsequently, voices in the industry continued to raise many doubts about the statement that "Stephanotis is anti-coronavirus".
Stephanotis is a binodyl isovalline alkaloid isolated from the stephanotis and Diosphorus of the Fanggenaceae plants. It has been previously approved for the treatment of leukopenia. The database of the State Food and Drug Administration shows that currently, four companies, Shenyang Guancheng Pharmaceutical, Yunnan Bio Valley Pharmaceutical, Yunnan Baiyao Group Wenshan Qihua Company, and Yunnan Baiyao Group Dali Pharmaceutical, have approval documents for Stephanotis tablets.
In fact, there is a lack of scientific basis for equating the above-mentioned patent authorization with stephanotis becoming a new drug for the treatment of COVID-19.
Image source: Beijing University of Chemical Technology WeChat public account
The patent specification shows that the patent name of the invention is "Pangolin coronavirus xCoV and its applications and medicines" Applications against coronavirus infections”. Specifically, the inventor isolated and cultured a new strain of coronavirus xCoV (not the new coronavirus that has been circulating since 2020) from dead pangolins seized by customs, which is called pangolin coronavirus xCoV.
Its whole genome sequence analysis results show that it has 92.5% homology with the S protein of SARS62COV622 (new coronavirus), making it the virus with the highest homology to the latter that has been successfully isolated and cultured so far. The inventor used this pangolin coronavirus xCoV to construct a model to screen and evaluate active drugs and vaccines against the new coronavirus.
In other words, the so-called stephanatine can inhibit viruses in vitro. What it inhibits is not even the new coronavirus, but a pangolin coronavirus that is very similar to the new coronavirus in the expression of S protein. .
The above-mentioned patent specification shows that the inventor believes that stephanatine is a promising drug candidate for the treatment of new coronavirus infection. In a test of three selected effective anti-COVID-19 compounds, including stephania, selamectin, and mefloquine hydrochloride, 10uM of stephania, selamectin, and mefloquine hydrochloride were effective in cell infection for 72 hours. Finally, it can inhibit virus replication 15393 times, 5053 times and 31 times respectively, and the experimental results can be repeated.
Tong Yigang said in a previous interview with the media that in layman’s terms, the above data refers to the fact that if stephanatine is used, the number of viruses produced will be very small, which is only equivalent to that without using stephanatine. One 15,393 times the amount of the virus, that is, a small amount of stephanatine can prevent the amplification and spread of the new coronavirus, and can suppress the new coronavirus to an extremely low level.
However, similar to the old drugs such as Shuanghuanglian Oral Liquid and Arbidol + Darunavir combination that have attracted public attention before, Tong Yigang’s team is currently targeting Stephanotis Xin also only conducted in vitro experiments at the cellular level.
Zhang Hongtao, former research associate professor at the University of Pennsylvania School of Medicine, told Jiemian News that the data of "inhibiting virus replication 15,393 times" is not that important to a certain extent, because in vitro, for example, using alcohol can also inhibit the virus. Reduced by tens of thousands of times.
In addition, the above report also quoted an article published in "Science" magazine in July 2021. The article stated that American researchers conducted a comparative study on stephanatine and 25 other candidate compounds. The results show that the EC50 of stephanatine against the new coronavirus (the concentration that causes 50% of the maximum effect, the lower the better) is only 0.1uM, which is far lower than other drug candidates, including remdesivir, which has been approved for marketing.
In this regard, Zhang Hongtao told Jiemian News that 0.1uM is a very important data, and it looks very good. But the most important thing is to go back to human trials to see whether stephanatine can achieve such an inhibitory effect in human trials. "It's just like you can eliminate all viruses with 70% alcohol, but you can't have the alcohol concentration in your blood reach 70% after drinking. If you don't reach this level, there is no way to achieve the effect of this drug." Zhang Hongtao said .
This is what is commonly referred to as "blood drug concentration" in the development of new drugs. If the required blood drug concentration cannot be achieved while ensuring safety, it will not be effective.
In fact, as a "promising drug candidate", it is still far away that stephanatine can be used to treat COVID-19.
As we all know, new drug research and development needs to go through three stages: drug discovery, preclinical research and clinical research including multi-phase trials to confirm or discover the clinical efficacy of the experimental drug. , pharmacological and pharmacodynamic effects, adverse reactions, and absorption, distribution, metabolism and excretion characteristics to determine the safety and effectiveness of the test drug.
Data show that in the development of new drugs, the median length of clinical trials in the field of infection is 7.1 years, and the success rate of new drug development is only 19.10%. While preclinical in vitro results are excellent, human clinical trials There are countless failed drug candidates, but from this perspective, there’s nothing special about stephanatine.
Zhang Hongtao further stated that even with some preliminary data from animal experiments, it may be easier to judge the effect of stephanatine in the 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 a real patent medicine can be approved for marketing. In addition, he also pointed out that there may be current hype about stephanatine, such as directly buying plants containing stephanatine to eat to prevent the new crown, which is "jumping and unfeasible." Stephanatine is very popular, but no clinical trials have been carried out yet 3
In the current era of repeated COVID-19 epidemics, 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 new COVID-19 treatment drug discovered by the team of Professor Tong Yigang, Dean of the School of Life Sciences and Technology of Beijing University of Chemical Technology, has been authorized by the national invention patent. According to the patent specification, 10uM (micromol/L) Qianjin Tencin inhibits coronavirus replication by 15,393 times.
Public information shows that CEP is a natural alkaloid extracted from plants. Among them, patent medicines are currently on the market in my country and abroad, and have been in clinical practice for more than 40 years. Information queried on the website of the State Food and Drug Administration shows that four companies including Yunnan Bio Valley Pharmaceutical and Yunnan Baiyao have approval numbers for Stephanotis tablets.
"Spiritosporine" with its anti-coronavirus concept has set off the stock prices of many listed companies. On May 16, stocks such as Biovalley, Youningwei, Dali Pharmaceutical, Buchang Pharmaceutical, North China Pharmaceutical, and Qianjin Pharmaceutical reached their daily limit, while Yunnan Baiyao, Rheinland Biotechnology, etc. once rose sharply and then fell back.
Multiple companies responded
The official website of the State Food and Drug Administration shows that Dali Pharmaceutical Co., Ltd. and Wenshan Qihua Co., Ltd., both affiliated to Yunnan Baiyao Group, have obtained The approval number of Stephanotis tablets was obtained. In response to the research and development progress of stephanatine against COVID-19, a person from the Yunnan Baiyao Board Secretary's Office told reporters that the company has paid attention to the matter and will respond as soon as possible through the investor interaction platform.
In addition, many listed companies have sent positive messages about the production of stephanatine. On May 16, in response to investors' questions, Uniview stated that stephanatine, as a biochemical reagent, is used in the research stage. Currently, the sales volume of this product makes little contribution to the company.
On the same day, Rhine Biotechnology stated on the interactive platform that stephanatine belongs to the alkaloids and the company has extraction technology reserves for similar products. If there is a large demand in the stephanotisin market in the future, the company will have the confidence to quickly carry out new technology research and development and respond to market demand in a timely manner, relying on many years of plant extraction experience and technology accumulation of similar products.
In addition, some investors also asked listed companies about the stocking status of stepheniacetin. Luyan Pharmaceuticals told investors that the company will prepare stocks based on actual business needs.
Affected by this news, the stock prices of many listed companies rose sharply. On May 16, Biological Valley and Youningwei reached their daily limit. Among them, Biological Valley rose by 30% for two consecutive trading days, which attracted attention.
However, according to reporters, among the above-mentioned listed companies with daily limit, Dali Pharmaceutical and Qianjin Pharmaceutical do not have business related to stephanatine.
Qianjin Pharmaceutical stated in response to investors’ questions that the main ingredient of the company’s product, Phytophyte Qianjin Tablets, is an alkaloid extracted from the dried cane of Fibraurearecisa Pierre. A binodyl isovalline alkaloid isolated from the plants Stephanotis capitata and Diospinia of the Fanggenaceae family. The two are not the same substance and have great differences in chemical structure and pharmacological effects.
Buchang Pharmaceutical announced on the evening of May 16 that the company’s wholly-owned subsidiary Shandong Danhong Pharmaceutical Co., Ltd. (formerly Heze Buchang Pharmaceutical Co., Ltd.) has “a preparation method for stephanatine hydrochloride. [Patent No.: ZL201010556531.0]" invention patent, the company currently has no R&D, production and sales of stephanatine-related products.
On the evening of May 16, North China Pharmaceuticals issued an announcement stating that at present, the company has not carried out technical cooperation with the relevant expert team on stephanotisin, and the company does not have stephanatine-related products.
Investors should "invest with caution"
According to media reports, a Canadian pharmaceutical company has already contacted the US FDA to conduct research on stephanatine. Clinical trial research on the treatment of new coronavirus pneumonia, which is expected to be officially launched in the second half of this year. In addition, Professor Tong Yigang also recently posted on social platforms that it will take some time for new drugs to reach clinical trials and be launched on the market.
A person from the secretary-general office of a listed pharmaceutical company told a reporter from Securities Daily, "Judging from the patent acquisition status, the above information has a certain degree of authority." However, it should be pointed out that the above-mentioned research has not yet entered clinical practice, which also means that it will take some time for stephanatine to be used to inhibit the new coronavirus.
In addition, Yin Baoqing, deputy general manager of Senrui Fund, said in an interview with a reporter from Securities Daily that stephania has just gone through the drug discovery stage, and will continue to go through pharmacology, pharmacology, toxicology, CMC and other steps can be used to apply for clinical trials. After approval, it can go through pre- and late-stage clinical trials before applying for marketing. Each of the above steps may fail. If the research and development is ultimately successful, we must also pay attention to the status of the new coronavirus epidemic and demand after listing, which are currently unknown.
“Listed companies with the new coronavirus concept are a hot topic in the capital market, but we must also pay attention to the risks of following the trend.” An investor told this reporter.