Biopharmaceutical - imitation success is also a high-tech NB industry!

What is the biological similar drug? First, introduce the difference between the original research drug (also called patent drug) and the generic drug Patent medicine is a kind of medicine produced by a company The R & D investment of patented drugs is very large Now, it is generally considered that the R & D cycle of a drug is 10-15 years, costing 1-16 billion US dollars (in fact, it is far more than that, because many calculation methods do not share the cost of failed drugs with that of successful drugs) Therefore, patent protection of the original research drug can stimulate the motivation of drug companies to develop new drugs After the patent protection of this drug is lost, that is to say, after the R & D pharmaceutical enterprises have made huge profits, all other companies can produce it - as long as you can prove to the pharmaceutical regulatory department that your drug is the same as the patent drug, and it will be finished with the approval of the pharmaceutical regulatory departments of various countries, so these drugs are called generic drugs Generics will cost a lot less because they don't need a lot of investment The design of this system takes care of the balance between inspiring companies to create new drugs and making drugs affordable for the common people, which is good in general Biological analogues as like as two peas of biological drugs, are given the name of a biological similar drug because generic drugs are required to be exactly the same as those of the original drug But because biological drugs are produced by cells, the molecules can not be exactly the same Even the companies that produced the original biological drugs, each batch can not be exactly the same So when the generic drugs of a biological drug reach a certain similarity, they are considered to be able to replace the original drugs, that is, biological similar drugs The rise of biopharmaceuticals Figure 1 shows the top ten drugs sold in the United States in 2004 (top) and 2013 (bottom) From the above figure, we can see: first, the market pattern has changed In 2004, the top ten drugs on sale were small molecule drugs (blue), but by 2013, only three of the ten drugs were small molecule drugs There is a non antibody protein drug (Lantus in the sixth row, purple), five antibodies (rows 1, 3, 6, 7 and 8) plus a protein drug with similar antibody structure (Enbrel in the second row), all expressed in jujube red This kind of change is similar to the mobile phone market - some mobile phone manufacturers were strong before, but they lost in the competition of smart phones, so the market position declined seriously However, due to the long cycle of the pharmaceutical industry, this change is slow Even so, Pfizer, which dominated by five top 10 drugs in 2004, could only share a second position with Amgen by 2013, while Roche acquired three top 10 drugs from Amgen for its acquisition of Genentech To avoid misunderstanding, I would like to emphasize that small molecule drugs will still be the first choice for many diseases in the foreseeable future, but the growth of antibody drugs is better in some areas Second, the annual sales of a drug can be very high Humira, developed by abbvie from Abbott, sells more than $10 billion a year Third, the overall drug cost has increased The total amount of drug sales in the top ten in 2004 was $28.2 billion, and by 2013 it had become $75.8 billion, nearly tripling Although the overall increase in prescription drug sales in the United States is not so large, it is also considerable This is a big problem of Western medicine mentioned by Jingda Even if these drugs are good, their high cost will also be a high social cost The characteristics of antibody drugs a very large share of biological drugs is antibody drugs We will analyze antibody drugs by "generalizing" Antibodies are part of the immune system, and healthy people have 12 grams of antibodies per liter of plasma Compared with small molecules, antibody has the following characteristics: 1 It can't be done completely by small molecules 2 Long half-life in vivo Because the half-life of antibody itself is usually in 10-20 days, it has a great advantage over the small molecules with a half-life of only a few minutes to a few hours Many small molecule drugs die during the development not because of insufficient activity, but because the half-life of the body is too short 3 Complex production Small molecules can be synthesized completely, while antibody drugs can only be produced by cells, and the cost is very high This sounds like a bad thing, but is it a good thing for the original drug development enterprises? Of course, because it raises the threshold of production, excludes other competitors, and costs too much If we don't change the profit margin, who cares? 4 The molecular weight of antibody is very large Generally, the molecular weight of IgG is about 150000 daltons, so the dosage of drug molecules with the same mole number is very high A single injection of Herceptin contains more than 400 milligrams of pure antibody molecules, which, in addition to the third point, is complex to make, rapidly pushing up the price of biological drugs Taking Herceptin as an example, a course of treatment in the United States plus other costs is 10 About ten thousand dollars This is not a good thing for patients and medical system, but is it a good thing for pharmaceutical companies? Have a guess! 5 Low toxicity Antibody is a part of our body's immune system, and our body has a good tolerance for it Seeing these, you should not wonder why biological drugs, especially antibody drugs, have become the target of all large, medium-sized and small pharmaceutical enterprises! The difficulties of biopharmaceuticals and the opportunities for Chinese pharmaceutical enterprises I was impressed by a post I read on the Internet a long time ago The title seems to be "high technology transformed into low technology by China", which covers many fields from program-controlled switch to shipbuilding, high-speed rail to satellite These technologies were once unrivalled, but when Chinese got involved, their price became cabbage price It is also mentioned that there are several high technologies that are still relatively weak in China, such as chips and biopharmaceuticals So why is biopharmaceutical so difficult? Just 15 years ago, it may be too much to say that there is no real drug research and development in China, but it is not far from the truth The phenomenon caused by various historical reasons and economic strength is that we really do not have drug research and development But these years, with money slowly growing, pharmaceutical companies are also motivated to make drugs better What's the best goal? Biological analogues For Chinese pharmaceutical companies, the research and development of bio similar drugs also provides a platform to catch up with foreign pharmaceutical companies in technology As I said just now, the R & D cost of a new drug is usually more than one billion dollars For a larger pharmaceutical enterprise, there are ten products under research, right? In this way, the average annual R & D cost will be 67 billion yuan, so let's see how many domestic pharmaceutical enterprises can achieve 67 billion yuan of annual turnover? Not to mention the development of several billion yuan, making biological imitations can improve the technology and technology rapidly With this, we have the entry license to enter modern medicine This can explain the prosperity of the development of bio similar drugs in China How grand is it? See the picture below China has become the largest country in the research and development of bio similar drugs Although there is still a lot of room for improvement in quality and technology, it is believed that the bio pharmaceutical manufacturing platform will be very mature in China Although imitation is often regarded as a symbol of backwardness, the imitation of biopharmaceutical is absolutely high-tech, because it is very difficult to produce a protein drug with cells, and to achieve the structure and activity indexes very similar to the original research drug The details are not discussed here Biopharmaceutical investment into the industry of Biopharmaceutics, I personally understand that it has not been very significant Because its technology has been very mature, so you can't rely on technology to capture cities and land, you can only rely on investment and management In addition, the final product is drugs Even if your technology is very good, you need a good drug sales team The capital cost and time cost are not what most people or institutions can or are willing to bear But focusing on biologicals may give you a good return on investment If a company has a very high sales growth in a few years, then its stock price should have a reaction? The U.S Biopharmaceutics has occupied the territory of small molecule drugs (see Figure 1) This is just beginning to happen in China, so I think there are better investment opportunities in it The figure below clearly shows the number of research and development of bio similar drugs in each pharmaceutical factory Although there are many projects, but because the R & D cycle of a drug is very long, from the perspective of investment, it will take too long for a drug to enter the phase I and phase II clinical, and the drug that has entered the phase III clinical seems to be more worthy of attention So I will summarize the situation of pharmaceutical companies that have entered phase III clinical practice, as shown in the table below: Unfortunately, several of the most important antibody drugs / bio pharmaceutical companies are not listed companies, and only two listed companies of Hualan bio and Haizheng pharmaceutical have antibody drugs that have been listed Huahai pharmaceutical has a product waiting for approval to go on the market Tonghua Dongbao and Zhijiang biology of the new third board each have a product that has entered the third phase of clinical practice I don't know about the investment, especially the domestic investment market I just hope to point out from a professional point of view that the domestic bio pharmaceutical industry is changing rapidly (because of the characteristics of the industry, the transformation will be slow), and early companies involved in bio similar drugs may be good investment targets Specifically, please give us more operational guidance from the investment experts.