Monoclonal antibody drugs become the leader in the pharmaceutical industry, the domestic forces are rising

In recent years, with the continuous advancement of new medical treatment in China, “pharmaceutical innovation” has become the key word for sustainable development of the industry. Pharmaceutical innovation is gradually becoming a major trend, and the confidence and determination of the regulatory authorities, practitioners, and capital are becoming firmer. The author was informed that in the two years of investment, monoclonal antibody drugs are the absolute mainstream.

Some experts said that other drugs in the United States are now more difficult to finance, but antibody drugs are always a direction. China's current pharmaceutical innovation is still in a period of rapid development. Although it is unlikely that the United States will have the same situation, it is foreseeable that monoclonal antibody drugs are becoming leaders in the pharmaceutical industry, both in China and the United States.

Monoclonal drug therapy mainly uses its targeting to interfere with various pathways during disease development and development, or to activate host immune to disease. It plays an important role in biotechnology pharmaceuticals and has gradually become the main direction of biomedical development. From the perspective of the global market, antibody drugs have become the focus of the international pharmaceutical industry, and M&A has become a shortcut for the international pharmaceutical giant to quickly enter the antibody industry. It is understood that after more than 30 years of accumulation, monoclonal antibody drugs from target development to technical improvement, from clinical research to commercialization strategies, all aspects are maturing, has become a well-deserved mainstream branch of the pharmaceutical field.

According to industry analysis, with the continuous development of biomedicine, there will be a more targeted monoclonal antibody and a more powerful "warhead", which will bring greater hope to patients. It is reported that the development of monoclonal antibody drugs has now entered a large-scale research and development period from the early piecemeal stage. In 2017, the global mainstream market was approved for 10 new monoclonal antibody drugs, the highest in history. With the introduction of various favorable policies in China, monoclonal antibody drugs are also rapidly emerging, and research and development efforts are gradually at the forefront of the international market.

According to relevant statistics, in the year of 2017, a total of five monoclonal antibody drugs were reported to the US for clinical trials. So far, 9 domestic monoclonal antibody drugs have been successfully applied for clinical trials in the United States. The application prospect of monoclonal antibody drugs is further broad, and domestic monoclonal antibody drugs are also rapidly emerging. It is understood that in order to promote the development of the antibody industry, the Shanghai Biopharmaceutical Industry Association Monoclonal Antibody Drugs Committee was announced at the meeting, the special committee will gather all the strengths of antibody drug research and development, manufacturing and related fields to jointly promote Shanghai single Resist the industrialization process of the industry, promote the development of Shanghai antibody drugs and industrial development.

Nowadays, domestic monoclonal antibody drugs have not only achieved good results, but also have been internationally recognized in terms of research and development strength. For example, Baekje Shenzhou, Kelun Pharmaceutical, and Yuheng Pharmaceutical have successively set up their own immune checkpoint inhibitor projects. Authorized to foreign companies.

The innovative research and development of monoclonal antibody drugs in 2018 is still one of the key projects in the development of China's pharmaceutical industry. Some experts have analyzed that domestic monoclonal antibody drugs will continue to focus on “me-too” and “me-better” in the field of tumor immunity in 2018. Domestic new drug research and development will be “me-too” and “me”. -better" is the main goal, and some emerging pharmaceutical companies will try to compare large technological innovations. And after experiencing early development, more companies will begin to consciously seek differentiation.

For example, Watson Bio announced on the evening of January 25 that the monoclonal antibody GB223 injection developed by Jiahe Biotech Co., Ltd. obtained the second clinical trial approval. The approval conclusion is that the product meets the relevant requirements for drug registration, and the product is approved for treatment. Clinical trial of osteoporosis in postmenopausal women. The announcement shows that the monoclonal antibody GB223 injection is a new class of innovative therapeutic biologics for Jiahe Biotechnology in China. It is a self-innovated R&D and has a new sequence of anti-human RANKL monoclonal antibody. Jiahe Bio owns core autonomy. Intellectual property. Compared with traditional drugs, monoclonal antibodies are highly targeted, can be directly targeted to the lesions, and accurately treat the corresponding diseases, with more significant safety and effectiveness.

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