Prospects for antibody drugs, international cooperation, and endogenous development of local enterprises
Some relevant people pointed out that the development of China's biomedical industry faces two realities that cannot be ignored. First, there is no “biotech drug†made in China sold in developed countries; second, no Chinese “biotech pharmaceutical company†is recognized by the international pharmaceutical industry. However, the good news is that the development of innovative biopharmaceuticals in China has also achieved some exciting results in recent years.
Since the advent of biotechnology, the development of global antibody drugs has gradually entered a mature stage, and the market competition for antibody drugs has become increasingly fierce. According to the PMR report, global biotechnology products will maintain an average annual compound growth rate of 10.1% by 2020, and the global antibody drug market is expected to exceed US$140 billion.
Recently, at the Summit Forum on the Development of China's Antibody Pharmaceutical Industry under the Global Perspective of 2017 in Suzhou, the relevant person in charge of the Biological Products Division of the Drug and Cosmetics Registration Management Department of the State Food and Drug Administration said that the current international antibody drug industry is concentrated. 90% of the products are developed and marketed by European and American pharmaceutical companies. It is worth noting that in recent years, the research and development of antibody drugs in Chinese enterprises has been enthusiastic and is favored by the capital market. Although international giants monopolize the market for antibody drugs, they have also spawned many new opportunities. With the advent of new targets and new mechanisms of action, China's R&D companies have made great achievements in the field of antibody drugs.
Antibody drugs have a bright future in China
At present, antibody drugs are the sub-industries with the largest proportion and the fastest growth rate among biological products. As of the end of July this year, a total of 79 antibody drugs have been approved worldwide. Since 2014, the proportion of newly approved drugs approved by the US FDA has been increasing, and it is expected to approach 30% this year. In 2016, the global antibody drug market will be large. It has reached US$96 billion, accounting for about 12% of the entire pharmaceutical market; among the “Big Bomb†drugs with global sales exceeding US$1 billion, there are 22 monoclonal antibodies.
In addition, there are currently 575 antibody drugs under research worldwide, and more than 110 newly approved antibody drugs are expected to be marketed in 2025. By then, the antibody drug market will account for more than 17% of the entire pharmaceutical market.
Compared with the global antibody drug market, the Chinese antibody drug market is still in its infancy.
A set of data provided by experts attending the conference showed that there are currently 23 antibody drugs listed in China. Among them, 13 are imported drugs, and only 10 antibody drugs are developed and produced by local companies, and 4 mouse antibody drugs have not been sold. In 2016, China's antibody drug market was 1.38 billion US dollars, of which 83% of the market share was monopolized by imported antibody drugs. “Among the 10 best-selling drugs in the world, 8 are bio-pharmaceuticals. But none of the 20 best-selling drugs in China are bio-pharmaceuticals.†Dr. Yu Dechao, Chairman of Cinda Biopharma, said, “In Regarding biopharmaceuticals, especially monoclonal antibodies, China’s status in terms of marketed products, research products, and market size is not in line with its status as the world’s second largest economy.â€
Some relevant people pointed out that the development of China's biomedical industry faces two realities that cannot be ignored. First, there is no “biotech drug†made in China sold in developed countries; second, no Chinese “biotech pharmaceutical company†is recognized by the international pharmaceutical industry.
Fortunately, the development of innovative biopharmaceuticals in China has also achieved some exciting results in recent years.
There are nearly 300 domestic companies involved in the field of antibody drugs. In the past five years, antibody drug companies have disclosed 47 financings, involving a financing amount of 13 billion yuan, and large amounts of financing have appeared frequently.
Many domestic companies' self-developed antibody drugs have been "selected" by international giants. For example, China's first monoclonal antibody drug with global intellectual property rights, Compaqip, has been directly linked to the US FDA's clinical phase III.
Li Jincai, vice president of Yaoming Biotechnology Co., Ltd. believes that in just a few years, China's biopharmaceutical research and development has been weak from the foundation to the present, and various projects have emerged everywhere, and a large number of professionals have emerged. People are happy.
International cooperation drives the endogenous development of local enterprises
In October 2016, Cinda Bio and Lilly reached a cooperation agreement to jointly develop and commercialize three PD-1 bispecific tumor therapeutic antibodies in China and the world. The two sides reached two comprehensive strategic cooperation with a total amount of US$3.3 billion, which became the largest amount involved in the China New Drug International Cooperation Project at that time.
In recent years, strategies similar to Cinda and Lilly's “bringing in and going out†have been fully applied in the field of antibody drugs. A total of 4 transactions have occurred, totaling 2.3 billion US dollars, demonstrating the “China†of the international market for antibody drugs. power".
So why are more and more companies willing to choose the form of international cooperation? This has also become a topic of concern to the industry.
“In the past, Chinese pharmaceutical companies may need to invest for more than ten years, until the new drugs are listed, and they will have a return. With independent intellectual property rights, they can continue to provide funding for enterprise development through overseas authorization, thus driving the company's endogenous development. Said Yu Dechao. In his view, the main reason for Chinese companies to choose more international cooperation models is the lack of funds. The development of antibody drugs has the characteristics of high input, high risk and long period. These factors bring great pressure on the research and development of antibody drugs. Since some of the basic materials required for the development of antibody drugs do not have the production capacity in China, Chinese antibody manufacturers must import materials, reagents, cells and other important materials from abroad. After doing the same research and development projects, plus taxes and fees, the direct cost of research and development of Chinese pharmaceutical companies is 23% to 25% higher than that of the United States.
As we all know, in addition to the large amount of capital investment required for the development of new drugs, there is a long clinical trial and approval process. Li Jincai said: "Unlike the oral administration of small molecule drugs, macromolecular drugs are directly injected into the blood of patients. The mature European and American markets are very strict with their product safety, quality monitoring and management." In China, developed in the past few years. Most of the products have not yet been listed, and the challenges that may be faced are not fully realized. It is not known whether the products can be stably supplied with high quality and safety in clinical or commercial production.
Pan Guangliang, vice president of Bios Biomedical, believes that the main gap between domestic companies and multinational pharmaceutical companies in antibody drugs is not in hardware, but in software, including quality control systems and human resources, and these are commercialization of products. is very important. In fact, in the United States, biological agents (including antibody drugs), while ensuring basic safety, although the process of development is simplified, but in the process of commercialization of later products, enterprises need to face more challenges.
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