Why domestic innovative drugs are always difficult to produce？ R&D investment lacks a long-term mechanism.

　　Focus on domestic innovative drugs

　　"I am like sitting on a false boat, jumping into the sea will die, and I can only let it go. It’s all about confidence. " Professor Huang Wenlin, Chairman of Cancer Center of Sun Yat-sen University and Guangzhou Dabo Biological Products Co., Ltd. (hereinafter referred to as "Dabo Bio"), jokingly described the feeling of insisting on new drug research and development.

　　Fifteen years ago, Huang Wenlin began to develop a new anti-tumor gene therapy drug — — Recombinant human dermatan adenovirus injection. Although this "innovative new drug from the source" has won the gold medal of China invention patent, the phase III clinical trial is nearly completed. But over the years, he has often been troubled by the shortage of funds and made slow progress.

　　Due to the lack of long-term investment mechanism, especially the imperfection of the capital market, the research and development of new drugs in China is difficult, and the industrialization of new drugs is "difficult to produce".

　　I especially hope that the government can light a "fire"

　　"Now, it has invested nearly 80 million yuan. Except for the support of major new drugs and major national science and technology projects, most of them rely on their own ‘ Huayuan ’ 。” In order to support research and development, Huang Wenlin founded Dabo Bio.

　　At the same time, in December 2017, Luxturna, a "direct drug delivery" gene therapy of an American company, was approved for listing. The drug research and development started two years later than Huang Wenlin.

　　Why did the United States start late and go on the market earlier than China for the same type of new drugs?

　　"In the United States, there is a complete R&D investment mechanism to support the research and development of new drugs. In the basic research stage of the laboratory, some enterprises and research institutes provide various funds to support innovative research. Once a product is developed, investors keep coming in. After listing, it has the advantages of product patents and product protection period, and pharmaceutical giants take over. " Huang Wenlin sighed, "But in China, all this is still far away."

　　"I especially hope that in the last mile when new drugs are about to emerge, the government can order them ‘ Fire ’ Guide venture capital funds to enter, so as to burn. " Huang Wenlin sighed.

　　Self-financing can’t afford huge R&D expenses.

　　Long research and development cycle, high investment and high failure rate are the three major pain points of new drug research and development, especially clinical trials.

　　New drug research and development is a "comprehensive project", a class 1 new drug, which needs continuous capital investment from project establishment to listing. "Among all the links, clinical trials are the ones with the longest duration, the largest capital investment and the highest risk." An internal person in charge of a domestic enterprise engaged in new drug research and development said that with the increasingly complicated design of clinical trial projects, the cost of clinical research has also risen.

　　"For innovative drugs, especially Class 1 innovative drugs, to complete all development, only global pharmaceutical giants can do it at present. After completing the early research and development and reaching the stage node, the average company is subject to the huge financial pressure of later research and development, and most of them will wait for the price, transfer the project to a large pharmaceutical company, or cooperate with it for development. " The above-mentioned personnel said that most small and medium-sized pharmaceutical enterprises in China mainly rely on self-financing for R&D, and R&D investment accounts for 4% of total sales on average & mdash; 8%, the investment is more than 20%.

　　In December 2015, Zhongshan Kangfang Biomedical Co., Ltd. (hereinafter referred to as "Kangfang Bio") awarded the global exclusive right to develop and sell its monoclonal antibody drug AK-107 for tumor immunotherapy to global pharmaceutical giant Merck. The former will receive an upfront payment from Merck and a phased payment with a total price of 200 million US dollars, covering development and promotion. In 2017, Kangfang Bio announced the completion of 300 million yuan Series B financing.

　　However, most new drug research and development in China are not as lucky as Kangfang Bio. Talking about the reasons for the cooperation between Kangfang Bio and Merck, Xia Yu, chairman and CEO of Kangfang Bio, said frankly, "The huge investment in new drug research and development is on the one hand, and another important reason is that the field of tumor immunotherapy is a field where top international pharmaceutical giants compete fiercely, and the speed determines success or failure to a great extent." She revealed that at present, not only clinical trials are advancing rapidly, but also research and development is progressing smoothly.

　　"The cooperation model between Kangfang Bio and Merck is a common cooperation model among pharmaceutical companies in the world." She said that the fundamental solution to the difficulties in the research and development of new drugs in China requires the progress and maturity of the pharmaceutical industry in China at all levels, including the improvement of the R&D strength of enterprises, the improvement of the regulatory system, and the real understanding and long-term support of the capital market for the long-term and high-risk research and development of new drugs.

　　Investors are unprofessional and cannot wait for a long period.

　　Once some competitive drugs go to the market, they can easily achieve sales revenue of over 10 billion dollars. Aren’t the big domestic pharmaceutical companies and investors excited about it?

　　"Domestic intellectual property protection is not perfect, enterprises are reluctant to invest huge sums of money, and investors feel that the risk is too great." Huang Wenlin said, "There was once a large domestic pharmaceutical company with 8 billion yuan in its hands. He asked me how to use this money. It’s not that they don’t understand, but they don’t dare. "

　　"From an investment perspective, domestic investors are immature and rarely really focus on investing in new drug research and development." Wang Yuefei, the founding partner of Jianjin Capital, said that a qualified investor should be familiar with the whole chain of drug research and development. "The lack of understanding of the new drug research and development industry, especially the industrialization link, coupled with the lack of mature funds, has led domestic investors to tolerate long-term investment in new drugs."

　　The internal person in charge of the enterprise engaged in new drug research and development mentioned above also said that investment institutions should truly understand the characteristics of the pharmaceutical industry. "If we simply apply the thinking of investing in the Internet, it may be a lose-lose situation."

　　Wang Yuefei has come into contact with many entrepreneurs in the pharmaceutical industry, including scientists. "Most entrepreneurs in the pharmaceutical industry in China have a technical background. The biggest problem is that they are not open-minded enough to control everything." He emphasized that "the success of foreign new drug research and development is better than that of China, because everyone in the R&D chain knows their role and can achieve division of labor and cooperation."