On February 1st, the authoritative medical journal “New England Medical Journal” (NEJM) published a number of papers on new coronavirus (2019-nCoV) cases online, one of which was about The case diagnosis and treatment process and the clinical manifestations of articles, after translation, quickly attracted domestic attention.
A 35-year-old man returned to Washington State after visiting his family from Wuhan, China, and was diagnosed with the new coronavirus. On the seventh day of diagnosis and admission to the isolation ward, after several considerations, the hospital doctor carefully decided to allow the patient to receive antiviral treatment on the seventh day of hospitalization-inject the patient with ridicvir.
On the eighth day, the patient’s clinical symptoms improved immediately. He no longer needed oxygen, and his oxygen saturation returned to 94% -96%.
At present, Radixivir is still a drug in the research and development stage, and it is not specially developed for the new coronavirus (2019-nCoV). It has not been approved for marketing in any country. Nor has it been confirmed.
But because of its better results, the drug development company Gilead is currently conducting a randomized, controlled trial with the Chinese health department to determine the use of Remdesivir to treat 2019-nCoV infection Is it safe and effective.
Affected by this, Gilead’s share price has reached a new high in 7 months.
It is not a potent medicine, but it is a well-founded “crooked”
In 2009, the U.S. FDA introduced a special policy, which mainly stipulates that if patients have a particularly urgent and life-threatening disease, doctors can make special applications to use those that have not yet been approved for marketing. Drugs in development. This policy is also known as the “sympathetic medicine” policy.
The constraints that can trigger this policy are quite harsh. It must be that the patient’s condition is particularly critical, there is no better way at hand, and it can only be used when there is no time for human clinical research. The US FDA can approve it every year More than 1,000 patients use this policy.
It is because of such a rule that Redecive was used in the first attempt to treat a new type of coronavirus infection in the United States.
In fact, Redecive is an American Gilead Pharmaceutical CompanyA drug developed for Ebola virus. After clinical research, this drug’s inhibitory effect on Ebola virus is not particularly good, and it is difficult to really bring it to market.
But the large R & D expenditure of pharmaceutical companies is not in vain. As an antiviral drug, Radixivir is similar to most antiviral drugs, most of which are targeted to the vital parts of the virus life cycle. The proteins were developed, and some viruses are actually similar in some proteins, so some crooked things may happen.
The premise of trying this is mainly because Redcive has already done a batch of human clinical tests against Ebola virus. The safety is still good, in short, it is to eat undead.
But one case of cure ca n’t be said that Radixivir is a potent drug against new coronaviruses. After all, doctors must have used a lot of treatments during the whole treatment process, not to mention the lethality rate of new coronavirus It is relatively low, and there are already some conventional means to cure it.
This is why the American Gilead Pharmaceuticals still needs to cooperate with Chinese medical institutions to conduct controlled trials. It is the same as the basic logic of the chemistry and physics class tests we learned in junior high and high school, mainly to control the variables. Determine if the drug Reddivevir is really effective against the new coronavirus. The design and final implementation of medical trials is actually more complicated than it sounds, but the purpose is indeed that.
Published progress is that the trial for Redecive will begin on February 3-27.
History of Gilead: A legendary gambler rejected by Buffett
Most people don’t know what Gilead did before the drug Ruedesvir cured American patients with new coronavirus. In fact, compared to many long-established pharmaceutical companies, this company does not have a long history, but it is indeed a very legendary company.
Gilead was founded in June 1987. The name of this company comes from an ancient Middle Eastern place name. The Gilead cream made here is regarded as the first real medicine in human history. The founder of Gilead was quite young when he founded the company, only 29 years old.
At that time, the company chose the direction of anti-virus. The pharmaceutical industry was a large investment in research and development and a slow profit, but the founder Michael L RiOrdan, as a person who received a Ph.D. in chemistry and medicine from the University of Washington and John Johns Hopkins University, later took an MBA from Harvard University and has done venture capital. Gilead has the first few venture capital investments in research and development.
In the first 10 years of the company’s establishment, the financial situation was quite bleak, when the founder wrote a letter to Buffy to ask for investment and was also rejected. Until October 1995, Gilead burned 8 years and $ 93.3 million in research and development funding (not too much for pharmaceutical research and development). The first new drug, Videide, was applied for marketing and later officially launched. . This company has gained the ability to win by itself and the trust of investors with its absolutely leading drug.
Later, the “gambler experience” gained by founder Michael L Riordan’s previous venture capital starts to show its power.
In 1997, Gilead had a revenue of only 40 million U.S. dollars and a loss of 28 million. However, with the total assets of its own company of 325 million, it announced the acquisition of NeXstar for 550 million. For the first time, the main source of investment has changed from cooperation funds to sales. The acquired products have contributed more than 200 million US dollars in revenue to the company.
Gilead then abandoned some of its long-established businesses and began to focus on the development of antiviral drugs. Since the 1980s, with the growing popularity of AIDS, Gilead has provided an excellent opportunity for rapid development. In 2001, Gilead’s first anti-AIDS drug, tenofovir disoproxil, was approved by the FDA. This product has become Gilead’s main source of wealth.
In 2003, Gilead acquired Triangle. The acquisition amount was the company’s total revenue for the previous three years. As a result, Michael L Riordan again “bet the win.” The drugs made by the acquired company became the company’s 10 years after. One of the main revenues.
Of course, the acquisition of capital alone is not enough. It depends on whether the drug developed is good or not. Gilead started out as a small company and can gradually stand out from other HIV drugs. The main thing is Because anti-HIV treatment requires long-term medication, and Gilead was the first company to focus on the simplicity of the dosing schedule, Gilead’s AIDS treatment drugs only need to be administered once a day to achieve viral suppression. Gradually captured most of the market.
With previous successful experiences, Michael L Riordan’s investment and acquisitions are even more bold, with 1.4 billion revenues in 2009The purchase of CV Therapeutics and the acquisition of angina pectoris Ranexa can only be regarded as a small piece of paper. The acquisition of Hepatitis C virus treatment drug manufacturer Pharmasset for $ 11 billion in 2011 was a crazy operation that made Gilead officially become a pharmaceutical giant.
At that time, Pharmasset reported a net loss of $ 91.2 million in the third quarter, and no products were launched. Oral hepatitis C virus treatments under development are not far from the market. In the end, Gilead acquired the company for $ 11 billion, and in 2014, when the hepatitis C miracle drug Sovaldi went public, its sales exceeded $ 10 billion, making Gilead the top 10 pharmaceutical company.
Like its own HIV inhibitors, Gilead’s hepatitis C drugs also focus on the simplicity of the administration plan, shifting the market for hepatitis C antiviral drugs from injections to oral administration, and the cure rate of hepatitis C has suddenly improved It’s 90%.
In 2009, CVTherapeutics was acquired by 1.4 billion U.S. dollars; CGI Pharmaceuticals was acquired by 120 million U.S. dollars in 2010; Arresto Biosciences was acquired by 225 million U.S. dollars; Calistoga Pharmaceuticals was acquired by 375 million U.S. dollars; in early 2012, Pharmasset was acquired by a huge amount of 11 billion U.S. dollars; 2013 In 2005, YMBiosciences was acquired for US $ 510 million, and Epiterapeutics was acquired for US $ 65 million in 2015.
Almost every year, Gilead takes out a small amount of money compared to its own company to acquire some leading-edge biotechnology pharmaceutical companies that are still in the early stage of the growth curve. For Gilead, the investment of several hundred million yuan is no longer a gamble, and a slightly marketed drug in its own product series can bring in a small revenue of one billion yuan each year.
The huge investment in research and development also means that Gilead’s drugs are quite expensive. Sovaldi, a hepatitis C elixir, sold for $ 1,000 a piece in the United States in the early days. The cost of a 12-week course was as high as $ 84,000, so in many markets, Gilead will also catch fire because the drug price is too high, and will be rejected when applying for patents in many countries. At that time, Sovaldi’s patent application was rejected in India and China. Due to pressure, he began to reduce prices in many developing countries, and later authorized Indian pharmaceutical companies to produce generic drugs.
But notIt means that Gilead’s R & D is not profitable because of its strong R & D capabilities and very fast product launch rhythm. Every year Gilead will have new drugs on the market. Many developed countries will use Gilead’s drugs more effectively. Putting the drug on the insurance list, reducing the price of several drugs or limiting the opening of generic licenses will not delay Gilead’s profit.
How much would China spend if Remdesivir is effective against the new crown virus
Because Gilead’s Remdesivir for the treatment of new coronavirus infections is still in the development cycle, on the one hand, it is not really guaranteed that this drug is effective, on the other hand, even if it is effective, China may spend on this drug A lot of money was introduced to purchase. According to the specific cooperation methods that Gilead has announced with China, Gilead officials only announced the signing of a cooperation agreement, and did not explain the patent authorization and cooperation methods.
The previous rumors that the United States Trump specifically approved a uniform exemption for drug patents and disclosed the molecular structure of drugs to China were also false. Because for Gilead, the research and development of this drug is also a huge investment, and it is impossible to authorize it for free simply because of the international rescue spirit.
But life is priceless. Whether it is Remdesivir or other drugs that will appear later, as long as it is effective against the new coronavirus, it will increase the hope for patients who have been diagnosed.