On July 5th, the 9th China Bio-Industry Conference and the first “China Optics Valley” International Bio-Health Industry Expo were held in Wuhan. A total of 14 professional segmentation forums were set up, and more than 100 biomedical industry veterans including Academician Chen Wei, Academician Gao Fu, Academician Cheng Jing, Academician Shen Buli, Academician Wei Yuquan and Academician Zhou Hongjun were invited. Explore the development strategy of biomedicine and medical device industry.
On the afternoon of the same day, the Forum 1 and the 5th China Innovation Biopharmaceutical Summit Forum (IBS 2016) were officially held. Chinese immunologist and academician of the Chinese Academy of Engineering Shen Beifen gave an opening speech for the forum. She said: "Biomedicine has become the world's newest round of innovation in science and technology, innovation and entrepreneurship, and the most active investment."
"In China, the bio-pharmaceutical industry has also received great attention from the state. The State Council has successively issued a number of policies and regulations to promote the accelerated development of the bio-industry, clearly listing bio-pharmaceutics as a strategic emerging industry. At the same time, the country's various science and technology plans are also added. Big investment in the biomedical industry;
Among them, the funds invested in the biomedical field during the 12th Five-Year Plan period more than doubled during the 11th Five-Year Plan period, reaching about 40 billion. ”
Antibody drugs are an important part of biomedicine
Academician Shen Beifen said that biomedical technology has ushered in a period of rapid development as a national strategic emerging industry. Antibody drugs are an important part of biomedicine, accounting for more than 1/3 of the total, and are the most active areas of biomedical research and development in recent years. As of 2015, more than 60 antibody drugs have been approved for marketing worldwide.
In 1997, global sales of antibody drugs were only $310 million; in 2015, the global antibody market has exceeded $70 billion.
4 major trends in antibody drug development
In recent years, the development of antibody drugs has presented the following trends:
First, as the first generation of heavy-weight antibody drug patents expired, the development of antibody-like drugs has received increasing attention. The United States and the European Union have successively issued a series of guiding principles for the development and evaluation of biosimilar drugs, encouraging the rapid development of biosimilar drugs. In March 2015, China also issued the “Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial)”.
The notification procedures, registration categories, and application materials for biosimilar drugs are regulated.
Second, breakthroughs in new technologies have led to the development of new antibody drugs. A series of novel structural antibodies such as ADC drugs and bispecific antibodies have developed rapidly.
Third, breakthroughs have been made in the clinical application of new targets and new mechanisms for antibody drugs. Among them, immunological checkpoint blocking antibodies have become a new field of tumor immunotherapy. PD-1/PD-L1 antibody has made a breakthrough in the clinical treatment of a series of malignant tumors such as melanoma and non-small cell lung cancer.
In addition, a series of immunological checkpoint inhibitor antibodies are in a state of focus. Cell-based therapeutic technologies such as CAR-T based on targeted antibodies have also made breakthroughs in clinical practice. A series of CAR-T and CAR-NK technologies that target hematological tumors and solid tumors are also in clinical research.
Fourth, the research field of antibody drugs is increasingly widespread. Antibody drugs were first used to combat immune rejection, but now, the use of these drugs has expanded to include tumors, autoimmune diseases, infectious diseases, eye diseases, cardiovascular and cerebrovascular diseases, and biosafety prevention and control.
In 2025, China's antibody market may exceed 30 billion
Although China's antibody drugs started late, they have developed rapidly. As of June 2015, China has approved the listing of 22 antibody drugs, including 10 domestically developed antibody drugs. According to statistics, at present, more than 400 antibodies have been applied for registration with CFDA.
During the “Eleventh Five-Year Plan” and “Twelfth Five-Year Plan” period, the state passed the scientific and technological plan of 863, science and technology support, and new drug creation, and invested more than 500 million yuan to support the humanization of antibodies and the preparation of human antibodies. /New structural antibody research and development, antibody drug quality control, large-scale production and a series of key technologies for antibody drug research and development and industrialization.
At present, more than 100 enterprises in China have developed monoclonal antibody drugs and initially formed an industrial scale. In 2014, China's antibody drug market reached more than 6 billion. It is estimated that by 2025, this market may exceed 30 billion.
The challenges facing China's antibody industry
Academician Shen Biao emphasized that China's antibody industry is also facing enormous challenges while it is booming: on the one hand, it is still in the stage of innovation and the transformation of cutting-edge scientific and technological achievements; on the other hand, it is studying biosimilar drugs. Mainly, lack of original innovation; in addition, antibody production, purification process, quality control level and industrial scale are still behind the international level; bioreactors, purification systems, scientific instruments and other key equipment, raw materials and reagents also depend on import.
