Ni Jian: It is difficult for antibody drugs to have a golden period of development in the next 5 years

Among biotech drugs, antibody drugs are the fastest-growing class of drugs in recent years. Due to technical and financial reasons, Chinese antibody drugs are mainly based on biosimilar drugs, and there are fewer innovative drugs. What will happen to the development of Chinese antibody drugs in the future? Recently, "Bio-Exploration" conducted an exclusive interview with Ni Jian, Chairman of the Suzhou Industrial Park Chenjian Antibody Group Co., Ltd., on issues related to antibody drugs.

Reporter: Hello Dr. Ni Jian, thank you for accepting our interview. What do you think about the development of China's antibody drug industry in recent years?

Ni Jian: As an industry, antibody drugs have developed in China for more than a decade. The great development has been in the last five years. Currently, there are not many domestic antibody R&D products that have been approved, and only 8 of them have been researched and developed in the country from the beginning to the end, and only 3-4 of them are used in the country, and the more traditional technologies are the monoclonal antibody technologies. There are few innovative products that use relatively new chimeric humanization technologies to enter clinical trials. There are quite a few imitations abroad, and antibody drugs have been approved for clinical trials. There are two or three of them doing well, and several products are doing clinical trials. Most companies are doing generic drugs for antibodies, both at the clinical trial stage or at the declaration stage. The overall problem is that there is a limited number of antibody drugs that can be copied. There are dozens of companies that make antibody generic drugs, and there are about a dozen companies that are reporting at the stage.

The competition in antibody generics has become increasingly fierce. How to avoid the blind imitation of biopharmaceutical genetic engineering drugs, and then compete to lower the price, affecting the development of the industry, this is our concern for companies doing antibody drugs. Since there was no patent protection for bioengineering medicine, the first batch of interferon and erythropoietin were approved by more than a dozen companies, and more than a dozen manufacturers approved it. In the past few years, everyone has pressed the price very low. The current product may be lower than the average price of antibiotics, and the ex-factory price may only be a few, which is totally inconsistent with the development of biomedicine. Therefore, this also has a bad effect on many investors investing in biopharmaceuticals. They think that even if biopharmaceuticals are approved, the output value is not high, and it is difficult to make hundreds of millions of products. The main reason for this phenomenon is that drugs are generic and there are many manufacturers.

Reporter: What is the market share of cancer drugs developed by Chenjian in the future?

Ni Jian: Market share is hard to say. It can only be said how effective it is for patients. It is estimated to be 60-70%. Because the classification of different diseases is now more and more clear, there are many new classification methods, mainly to see the number of patients cured by drugs. Just now it was also mentioned that the cure rate of the chemical drugs approved by foreign countries for treatment of tumors is also in the range of 20-30%, so tumor drugs are difficult to do, even if the chemical drugs they make do not have a clear effect on tumors. The requirements of clinical laboratory guidelines for oncology drugs are such that anti-tumor drugs all have certain toxicity. Under normal circumstances, normal people will not be used for clinical experiments. When a phase of clinical trials is performed, it is necessary to have other treatments that have no effect. The patient will do a phase of clinical trials. This is the particularity of cancer drugs for a phase of clinical trials. This is not the case in the market later.

Reporter: Why is it difficult to make innovative drugs in China?

Ni Jian: It is very difficult to make innovative drugs in China, and there are not many companies that really insist on doing innovative drugs. One reason is technology, no talent, and there is not enough financial support. Therefore, it is necessary to solve the problems of talents and technologies. What is more important is the orientation of the government and the change of investment attitude of many investors. Despite the creation of a major national new drug, the proportion of truly innovative drugs supported is also very small.

Reporter: During the 11th and 12th Five-Year Plan period, the Ministry of Health and the Ministry of Science and Technology have invested many projects. What are the changes in project selection now?

Ni Jian: The Ministry of Health and the Ministry of Science and Technology, including the creation of major new drugs, have some changes in the selection of projects, but the changes will not be too great. This involves the management system and the choice of experts, as well as the evaluation system. I participated in several major project reviews of the “Eleventh Five-Year Plan” and “Twelfth Five-Year Plan”, including conclusions. Recently, the Ministry of Health and the Ministry of Science and Technology jointly held two options and reviews for biosimilar drugs and antibody drugs. Leaders and experts are aware that although many projects have been invested during the “Eleventh Five-Year” and “Twelfth Five-Year Plan” period, it is difficult for China to have the ability to make blockbusters and to enter the international market from the perspective of biosimilar drugs and antibody drugs. The market for antibody drugs, because most of them are doing generic drugs.

The country is now also a support method for projects that hope to change. It is hoped that through top-level design, leaders and experts will recommend good projects to see whether these projects can make heavy drugs. Our company's project has also been reported as one of more than a dozen companies for hot elections. However, whether or not it can be selected in the end depends on the evaluation mechanism. Because some experts emphasize the maturity of the project, when they enter the clinical stage, they can become products for several years. Some experts may emphasize innovation, and different experts still have different opinions on how to do antibody drugs in China.

Reporter: According to your prediction, what is the development trend of the antibody industry in the next 5-10 years?

Ni Jian: It is difficult for the antibody drug industry to have a golden period within five years. The number of antibody drugs that can be predicted and approved within five years is small, there may be several within 10 years, and generic drugs may also exist, but the effect can be similar to foreign drugs, and the cost is also Almost the product is still more difficult. Because of the difficulty in making antibody generics, there are many drugs that are difficult to know at a glance how foreign antibody generics are made and how antibody structures are.

Now many domestic companies that do antibody copying drugs need to buy foreign antibody drugs. Through repeated amino acid and protein sequencing, the antibodies are determined. When foreign companies do drug research and development, they apply for patents, apply for projects, and publish articles. To protect patents, they do not clearly tell how the structure of the final product is. This requires the antibody generic company to figure it out. However, some antibodies, from the perspective of amino acid sequencing, are difficult to measure on both sides, and amino acid sequencing also takes a lot of time and effort.

Reporter: Due to the peculiarities of the biopharmaceutical industry, when drugs are researched and developed, how can the fastest industrialization be considered by companies? How do you see this?

Ni Jian: The industrialization of pharmaceuticals is not only the input of talents, technology, and funds, but there is one more important policy of the government. Because the entire drug project's declaration, approval process, and review criteria are difficult to adapt to the development of drugs, it is on the one hand to encourage innovation, on the other hand new things experts are difficult to pass, SFDA will not be approved soon. It is now more than a year to wait for approval. In 2011, antibody drugs, including antibody generics, were not approved, and most of the approved documents were returned more than one year ago. Even if new antibody drugs get clinical approvals, there are many resistances to entering clinical hospitals for clinical trials. Many doctors are unwilling to use these drugs.

Reporter: Comparison of gene therapy and antibody drug industries?

Ni Jian: The gene therapy drugs have developed several years later than the antibody drug industry. The degree of maturity of the entire industry There is no maturation of antibody drugs in gene therapy drugs. At least, antibody drugs have formed an industry. There are dozens of products, and the market share is several hundred billion, which is already a big industry.

Reporter: The competition in the antibody industry has become increasingly fierce. How can Chenjian maintain its long-term development capability?

Ni Jian: At present, the difficulties faced by new drug R&D companies are more than those of other companies, because many investors do not dare to invest, including local governments and investment institutions will also have some short-term benefits, if there is no large product sales revenue in two or three years. There will be less support. Our morning health is rather special. There are 4 state-level financial support. There are altogether more than 20 major new drug creation projects in the entire BNB, and we account for 4 of them. The 863 project also has support. In addition, we are really interested in biomedicine and interested in antibody drugs. We understand the industry, and companies and partners that dare to invest in this industry will cooperate with us to be able to move forward. Of course, there are some choices now. We are considering which method can make antibody drugs faster and reflect the value of the company.