Sang Guowei: there are many challenges in the R & D and production of biological analogues

Sang Guowei, academician of the Chinese Academy of engineering and chief engineer of the national science and technology major project "major new drug creation", pointed out at the 4th International Pharmaceutical Expo recently that in the future, biological analogues will play an important role in clinical treatment, but there are many challenges in the research and development and production of biological analogues Therefore, it is necessary to build the investment value chain of biomedical industry Biopharmaceutics refer to a kind of products for prevention, treatment and diagnosis, which are made by using the research results of biology, medicine and biochemistry, and the principles and methods of physics, chemistry, biochemistry, biotechnology and pharmacy, etc Its active ingredient is the product of biological substance They can be a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, sensitizing product, protein (except chemically synthesized polypeptide) Due to the complexity of biopharmaceuticals, including the complexity of structure and production process, only in the same structure, efficacy and safety of the original research biopharmaceuticals, there can be no identical biopharmaceuticals Therefore, for biological drugs, there is no concept of generic drugs, only the concept of biological analogues According to Sang Guowei, innovation in China's biomedical industry is particularly important to meet the needs of more patients Therefore, many people expect that biological analogues play an important role in the clinical treatment, to a certain extent, it solves the problem of the availability of high-tech drugs for the Chinese people, and greatly reduces the price of drugs, so that more low-income patients can get the treatment of high-tech drugs, and provides solid support for the medical security in China But he also pointed out that there are many challenges in the research, development and production of biological analogues First, due to the complexity of protein structure, any slight change of protein sequence, structure and post transcriptional modification may change its safety and effectiveness; Second, the stability of the protein product is greatly influenced by the preparation The stability of the protein in the preparation different from the original research plant may reduce the change of the purification method of the protein, which may result in the change of the purity characteristics of the final protein product; Third, any slight change of therapeutic protein itself or preparation may result in the change of immunogenicity of the product, thus affecting the safety of biological drugs "In fact, there is a huge risk of innovation in biopharmaceuticals around the world." Sangguowei pointed out that it is necessary to build a complete investment value chain of biomedical industry, commit to the phased embodiment of innovation value, realize the company's value-added and early investment exit in the early important links of drug development, create a successful business model, and create an investment atmosphere for early innovation projects It is reported that the investment value chain of biomedical industry includes contacting the upstream and downstream industry investment teams, establishing the investment chain supported by the angel or government's early rising investment, scientific research funding, innovative drug venture capital fund, late private fund and industrial giants, so as to achieve sustainable capital support and industrialization promotion He pointed out that at present, the focus of R & D of large multinational pharmaceutical enterprises began to be adjusted to gradually form the pattern of chemical pharmaceutical industry and biological medicine; the pattern of global driven strategy and biological medicine; the market of biomarkers and diagnostic technology promotes the R & D of drugs and diagnosis; and the new diagnostic technology that can predict the efficacy and adverse reactions "The human genome project has just begun to advance, and the discovery of new molecular entities to drug development pipelines is the best era for drug discovery and development science We must seize the opportunity " According to him, in 2014, the focus of national support for biological drugs included: new adjuvants and therapeutic vaccines for vaccines; antibody small molecule coupling drugs and bifunctional antibodies; stem cell therapy; synthetic biological technology and products; biopharmaceutical drug administration and release technology; recombinant coagulation factors; international cooperation platforms for quality standards such as antibodies and similar biological drugs.