Medical Network October 16th "The target is like a specific stone that forms a pyramid. It is there, but it is not an easy task to find it accurately." October 14, Nanjing Legend Biotech Dr. Fan Xiaohu, Chief Scientific Officer, said in an interview with the Science and Technology Daily.
From the discovery of the PD-1 molecule to the discovery of related drugs and the award of the Nobel Prize, the Japanese immunologist Benedict spent 26 years. It is difficult to find a target. This is the consensus of the global new drug research and development industry, especially in China.
"In 2008, since the implementation of the new drug creation system, China has approved 35 Class 1 new drugs, but none of the targets were first discovered by themselves." Major new drugs created the national science and technology major project (referred to as the new drug creation special project) technology deputy chief, China Chen Kaixian, an academician of the Academy of Sciences, said that since the beginning of this year, almost every one or two months, a new drug independently researched and developed by China has been approved for listing, showing an unprecedented concentration of outbreaks.
However, compared with the advanced level of developed countries, there is still a big gap in the research and development of new drugs in China. Chen Kaixian said that most of the innovative drugs in China are still developed on the basis of the mechanism of action and targets found abroad. The basic research is weak, and there is no new mechanism, new target and core technology pioneered by China. As a result, our new drug research and development is still along the path of others.
Bit hard to find domestic drug innovation bottleneck highlights
The target is the basis for the development of new drugs, and a target can make an industry. "China's innovative drugs really have to break through, we must start from the discovery of the target." Wei Yuquan, a member of the Chinese Academy of Sciences and a professor at Sichuan University.
Where is the difficulty in finding new targets? Fan Xiaohu told reporters that the binding site between drugs and biological macromolecules is the drug target. The target of drug action can be receptors, enzymes, ion channels, transporters, immune systems, genes, etc., and its discovery and verification is a very complicated process. “Firstly, we need to find a regulatory pathway related to the development of the disease, discover its core protein through the pathway, and see the structure of the protein, especially the center of the structure, that is, the core part that controls its operation. Just like a lock, to find and The matching key, the key is only inserted into the door, but also can be rotated, on the basis of the synthesis of small molecular compounds can be effective for the disease." Fan Xiaohu said.
Fan Xiaohu said that even with a theoretical (potential) good target, it is not always possible to develop a good drug, because artificial design and natural drug screening have many limitations, and the safety of the drug candidate obtained remains to be determined. Investigate, drug metabolism, toxic side effects can affect the drug properties. "The discovery and confirmation of domestic drug targets still lack effective methods and techniques, so that the discovery of new targets is rare," said Du Guanhua, vice chairman of the Chinese Pharmacological Society.
Chen Kaixian believes that the new drug research is a complete technology chain, including the discovery and confirmation of targets, the discovery and optimization of new drug lead compounds and the determination of candidate new drugs, involving many links. But original innovation is especially important. Taking anti-tumor drug research and development as an example, for decades, there have been many research hotspots such as cytotoxic drugs-tumor angiogenesis inhibitors, but none of them were pioneered in China.
“The original innovation and breakthrough of the underlying commonality and core technology are also extremely important.†Chen Kaixian said that if antibody-conjugated drugs (so-called ADC drugs), antibodies are like a missile, and the drug is accurately transported to the tumor site to play a role, how to put The combination of antibodies and anti-tumor drugs with chemical bonds is a key core technology. Without mastering these technologies, the development of ADC drugs will encounter the bottleneck of "card neck".
Let the big pharmaceutical companies prohibitive risk
As we all know, the research and development of new drugs has the saying of “two highs and one longâ€: high investment, high risk and long cycle. Dr. Li Ying, Senior Director of Strategic Cooperation of Beida Pharmaceuticals, said that a new drug must undergo a series of studies, such as in vitro, preclinical animals, clinical I, II, and III, from the beginning of development to the approval of the market. There are no shortcuts. 10 to 15 years is a normal time and costs at least $1 billion.
"From tens of thousands of drug candidates to new drugs with drug-based, three-phase clinical trials, this process is really a life of nine deaths, and the development costs are huge. Chinese companies are willing to invest large sums of money for research and development." Fan Xiaohu said. Indeed, a person who is engaged in research and development of new drugs in the United States also said that domestic intellectual property protection is still not perfect, and almost no enterprises are willing to invest huge sums of money.
Therefore, Li Ying said that the domestic targeted drug research and development is based on me-too, me-better (I also follow, but do better), whether it is a large molecule or a small molecule, are in the established target The drugs found on the new target are basically blank. It is understood that the total number of therapeutic drug targets discovered so far is more than 500, and there are about 20 domestic drug developments, such as EGFR, VEGFR2, HER2, and PD-1. "This kind of enthusiasm is quite serious. In order to avoid risks, companies often redesign their chemical structures based on existing targets abroad, and develop new drugs, resulting in dozens of similar drugs in their research. Qualitative competition also causes waste of research and development resources and funds." Chen Kaixian said.
"Really, the first drug of the new target has a very large risk, and of course there will be a huge return." Li Ying said, taking the CDK4/6 target as an example, the first drug was developed by Pfizer and sold. 3 billion US dollars, the second is Novartis, sold 200 million US dollars, the third only sold 70 million US dollars. If there is no first-mover advantage, the gap between market sales and the first mover is huge. Therefore, it is still necessary to make more new targets. In contrast, the creation of new drugs in China has only begun for more than a decade, and it cannot be done overnight. It needs to accumulate in the long run.
Heart difficult static baton is critical
“The discovery of new targets is generally from high-level papers.†Fan Xiaohu said that the current domestic scientific and technological evaluation orientation and the number of papers and the evaluation mechanism of impact factors make it difficult for scholars to calm down and explore. The research direction runs, which makes it easy to produce data and publish papers. This kind of follow-up research is easy to make and difficult to innovate.
Li Ying said that the target and mechanism of targeted drugs are generally first discovered in research institutes and universities in developed countries. It is not the large pharmaceutical companies and industries that really find new targets. Universities and academic institutions are national priorities and fund inputs. The entire basic research in the United States is very strong. Researchers publish the results of basic research breakthroughs in top magazines, and companies follow suit to find drug candidates. From this law, the key to the discovery of new targets in China is that the basic research on the original innovation of our universities and research institutes is weak, and there is still a considerable gap compared with developed countries, especially in biopharmaceuticals. .
In the above-mentioned research and development personnel in the United States, the masters of martial arts are all people with deep internal strength, and basic research is like internal strength. Take PD-1 as an example. When it was first discovered, it did not know what it could do. The discoverer thought that it was a protein related to apoptosis. Experiments showed that the knockout mice showed that it is related to immune diseases , and then further The study found that it has the role of a negative regulatory factor.
"If there is no deep basic research and curiosity, it can't be combined with other aspects, and it can be linked with tumor control to form an innovative way to prevent immune response by blocking PD-1. Said the above person.
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Located in Chengdu, founded at 2004, Chengdu JRT Meter Technology Co., Ltd is a manufacturer and trading company,which is specialized in R&D, processing and selling laser distance meter and modules for 15 years. JRT is one of the leading companies focused on manufacturing laser distance modules in China. We can do OEM designs and make functions as customer required base on our excellent R&D team. JRT is the only factory can make laser distmeters and modules with schemes of single transmit and single receive in china, which greatly reduced our production cost. JRT always make efforts keeping manufacturing laser distance modules cheaper, smaller but with higher quality. Customers` needs are always being the most important things to our company. JRT do its best to make all customer satisfied. To do that, we are keeping improving our quality, service and technology. Making every measurement simple in life is our goal.
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