China's new drug development breakthroughs in a number of key technologies

Business Club April 20 News Drug design, new target discovery, preparation technology, modern Chinese medicine research, vaccine development, antibody drug preparation, microbial drug fermentation, peptide drug structure design, etc. -

Beijing News reporter Bai Yi reported that Ma Hongjian, deputy director of the China Biotechnology Development Center, revealed at the 3rd China International Conference on Key Technologies for Innovation Drug Creation that during the “11th Five-Year Plan” period, major science and technology major projects for “major new drug creation” were jointly supported and The project has achieved significant progress in 99 key technology projects.

In the field of computer-assisted drug design research, China has developed a number of new technologies and methods with its own characteristics, which has improved the accuracy and practicality of drug design. A group of innovative drugs such as "Cancer Tide" have been developed. (Cantide) has entered clinical studies.

In the field of new drug targets and new mechanisms, a number of functional proteins with drug target characteristics were discovered, proving the possibility of some biomacromolecules as drug targets. For example, EphrinA2 discovered by the Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences has the potential to become a drug target for liver cancer treatment. Lysyl oxidase is not only a molecular marker related to the prognosis of lung cancer, but also a potential target in the treatment of lung cancer metastasis.

Research on pharmaceutical preparation technology has progressed rapidly. The development of the absorption-promoting carriers for insoluble orally soluble pharmaceutical preparations has made some progress. The research on slow and controlled release technologies and materials as well as targeted preparations has progressed significantly. Percutaneous penetration technology, microsphere technology, nanotechnology, and osmotic pump controlled release technology have also been noticeable. Achievements. In addition, a systematic study has been conducted on the analysis methods, stability evaluation methods, biological evaluation methods, and quality control methods for crystalline drugs.

The modern Chinese medicine research leveraging life science technology has achieved a welcome breakthrough. China released the world's first medicinal plant genome framework, “Salvia Genomic Framework Map”, marking that Chinese medicine research has also entered the age of genomics. Researchers in China have established a drug network and biological network to predict drug targets at the entire genome level and use the clustering characteristics of target spectra to discover new uses or toxic side effects of drugs. On this basis, it provides a certain scientific basis for the mechanism of traditional Chinese medicine Liuwei Dihuang Pills to treat different diseases with one another. Scientists in China have also accelerated the pace of research on "DNA barcoding" technology and have done a lot of research on the screening of DNA barcodes for medicinal plants. It is recommended that ITS2 fragments be used as standard DNA barcodes for identifying medicinal plants.

In terms of vaccine development, China has initially formed a technical and regulatory system that meets international norms. For example, the first recombinant Helicobacter pylori vaccine successfully developed in the world has achieved significant results in preclinical key technologies such as the construction of a novel vaccine molecule model, establishment of a long-term stable animal model of Helicobacter pylori infection, low pH, and stability of trypsin environmental vaccines. breakthrough. Using the fingerprint identification system and vaccination management electronic information system, it has completed the phase III clinical study of the world's largest recombinant human hepatitis E vaccine and effectively organized more than 110,000 volunteers. Related results were published in the "The Lancet" and other international authorities. The journal was highly praised by international peers.

Pharmaceutical companies such as Shanghai CITIC Guojian Pharmaceutical Co., Ltd. and Beijing Baitai Pharmaceutical Co., Ltd. achieved breakthroughs in the large-scale preparation technology of antibody drugs, and the antibody preparation has been upgraded from one hundred to one thousand scale, and the scale of cell culture has been enlarged. The key technology processes such as pollution control, agitation, gas transmission and cell growth have solved the key technical difficulties in the scale-up of protein purification from hundred grams to kilograms. Established a new technology for functionalization of antibodies, identification of antigenic epitopes, humanized and fully human antibody construction and optimization technologies, improved the fully synthetic antibody library, and developed a series of new products, such as the Institute of Biophysics, Chinese Academy of Sciences, based on new targets. Development of anti-tumor vascular endothelial antibody drugs.

The pharmaceutical companies represented by Shijiazhuang Pharmaceutical and North China Pharmaceutical have also made breakthroughs in a series of key technologies such as the transformation of microbial fermentation engineering bacteria, fermentation tank design, and fermentation process control, which has enabled Chinese microbial drugs represented by antibiotics and vitamin drugs to be represented. The technical level has entered the international advanced ranks.

In addition, China has made remarkable progress in the structural design, scale synthesis, and drug delivery of peptide drugs. Through the study and modification of the structure-activity relationship, on the premise of maintaining biological activity, defects such as poor stability of peptide molecules are solved, and the diversity of molecular structure of the modified peptide is increased. The synthetic ability of peptide medicines such as the Academy of Military Medical Sciences and Sichuan University has reached the kilogram level and the purity has reached more than 98%. Successfully developed vesicle-type nacre calcitonin powder mist and leuprolide long-acting injection sustained-release microspheres and other polypeptide preparations with independent intellectual property rights, providing feasible non-injection and long-term administration of such drugs. Technical route.

Ma Hongjian stated that during the “Twelfth Five-Year Plan” period, the “Research on Key Technologies for Research and Development of New Drugs” in the “Creation of Major New Drugs” project will fully utilize and integrate the latest achievements in the fields of life sciences and high-tech research, aiming at the research and development of innovative drug restriction and The technical bottleneck of industrialization strives to achieve 20 to 30 major breakthroughs, providing support for improving the level of R&D and industrialization of new drugs in China and the sustainable development of the industry.