The Initial Growth Of China'S Antibody Medicine Industry, Production Capacity, Technology, Talent Development Constraints

"Antibodies are of great strategic significance for the safety and security of China's biotechnology. For example, at present, China's disease burden is very heavy, and many antibody preparations are breakthrough therapies. The development of antibody medicine industry is of great significance for us to achieve some important health goals in healthy China 2030." Recently, shortly after the release of the report on the healthy development of China's antibody drug industry (hereinafter referred to as the report), Chai Yan, iqvia's Management Consulting Director, pointed out in an interview with the 21st century economic report.

However, Chai Yan also pointed out that at present, China's antibody medicine industry is still in the early stage of growth, with a small market size, only 1% of the total market in the United States and Europe, and the market share of local enterprises is very small. "This is because there are still many shortcomings in the core competence of China's antibody medicine industry, such as production capacity and key technologies."

In the opinion of the National Health Commission, the development of the national health care center is inseparable from the research team's ability to guide the development of the health industry. "The industry itself needs to strengthen the protection of talent funds, build R & D and innovation capabilities, quality assurance capabilities, cost optimization capabilities and product supply capabilities; government policies should focus on promoting industrial technology progress, ensuring clinical safety and maintaining good development expectations, and focus on promoting the improvement and optimization of innovation development policies, quality and safety policies and medical insurance procurement policies."

Jin Chunlin, an expert of the research group and director of Shanghai Health and health development research center, suggested further in-depth study and demonstration on the purchase policy of antibody drugs, fully considering the characteristics of antibody drugs products, industrial development stage, clinical needs and patient safety, and strengthening the coordination of procurement policies with drug supervision and clinical norms, so as to achieve drug use for patients through scientific procurement policies Three win situation of security, medical insurance fee control and industrial development.

Antibody medicine becomes a new favorite

Antibody drugs are special macromolecular biopharmaceuticals, which are widely recognized by patients and regulatory agencies.

Many cancer patients have benefited from the development of antibody drugs. For example, rituximab, launched in 1997, provides a better immunochemotherapy regimen for patients with non Hodgkin's lymphoma; trastuzumab significantly improves the survival rate and survival time of breast cancer patients. In recent years, antibody drug PD-1 has brought a new choice of immunotherapy for cancer patients, which makes cancer patients obtain higher survival rate and longer overall survival period.

To this end, regulatory agencies in various countries have also recognized the therapeutic effect of antibody drugs. Since 2012, FDA has implemented the "breakthrough therapy" policy to provide preferential treatment for drugs with significant curative effect. By the end of 2019, among 165 "breakthrough therapies" identified by FDA, antibody drug therapy accounted for 62. At present, China's drug administration has released a total of two batches of overseas new drugs in urgent need, including 78 drugs, of which 22 are antibody drugs.

However, the market share of local enterprises is very small. Up to now, only five domestic antibody analogues have been listed in China, and the first one was approved only last year.

In fact, antibody drugs have good efficacy and high specificity, but the birth of antibody drugs is challenging and not easy. Different from small molecule chemical drugs, antibody drugs are macromolecular biological drugs with complex structure, high difficulty in research and development and production. The research and development of an antibody drug takes more than ten years and costs several billion yuan. It is sensitive to thousands of different drug production processes and processes.

Jin Chunlin pointed out that the characteristics of antibody drugs are immunogenicity, the complexity of manufacturing, and the relatively short time to market, so we should pay close attention to the clinical efficacy risk and safety risk. The two risks are very important, and their side effects must be tracked for a long time to accumulate data. These two requirements are very high.

Coordinated development of policy and Industry

In Chai Yan's view, China's antibody medicine industry is still in the early stage of development, and its production capacity and core technology need to be improved. These stage problems still need long-term technology accumulation and innovation development to make up for the shortcomings.

First of all, the total production capacity of antibody drugs in China needs to be greatly increased. At present, the actual total production capacity of antibody drugs in China is less than 200000 liters, and the maximum production capacity of a single enterprise is 38000 liters. The total production capacity of neighboring South Korea is 760000 liters, and the production capacity of multinational enterprises is more than 200000 liters. As the production of antibody drugs is extremely complex, the expansion of its production capacity needs to go through a long process. Whether these fluctuations in patient capacity and market demand are worthy of attention.

Secondly, the key technology capability of the industry is insufficient. Due to its late start and weak foundation, the core competence of China's antibody drug industry is deficient. China's basic research on antibody medicine industry is still lagging behind the top level in Europe and the United States, and the research, production and transformation capacity needs to be improved. The construction of key technology platform has just started, and the key materials have not yet been made in China, mainly imported. The production cost of antibody drugs is high, and the cost control ability is still insufficient. The lack of these capabilities limits the technological innovation and competitiveness improvement of China's antibody drug industry. The development of the whole industry needs sufficient time to cultivate competitiveness.

"At present, the low production capacity in China is due to the weak ability of the whole cell culture and the relatively low stability of our cell culture. In addition, the whole production of antibody drugs related personnel is actually relatively scarce. If we want to speed up the development of this industry in China, talent is the first factor. There are two main sources of talent. One way is that enterprises and colleges constantly cultivate and strengthen themselves. On the other hand, it is introduced from the outside. " Chai Yan said.

Gu Xuefei believes that China's antibody medicine industry is still in the early stage of growth, which cannot be separated from the two wheel drive of industrial construction and policy optimization.

"At this stage, policies need to play a core role in three aspects: first, shaping good expectations of the industry and promoting multi-channel capital investment in the industry. The second is to guide the industry to develop in a standardized and high-quality way. Third, strengthen industrial R & D capability. These three core tasks correspond to innovation and development policy, quality and safety supervision policy and medical insurance procurement policy respectively Chai Yan pointed out.

Jin Chunlin stressed that in order to ensure the safety of patients' medication, it is necessary to promote the standardized use of antibody drugs in the clinical process, especially for patients who have used antibody drugs, and should try to avoid the risk caused by changing the medicine midway. In addition to talent and other R & D support, tax support and education support, it is particularly important to include medical insurance reimbursement at the consumer end.

"How to get reimbursement? From the perspective of medical insurance, there are several ways to support industrial development, such as whether it can be included in the scope of medical insurance reimbursement; what is the reimbursement proportion or payment method. In recent years, we can share the risk according to the international prevalence. For example, the efficacy of this antibody drug in some tumors is better than that of other methods, and it is more effective and cost-effective, so it can be included in the scope of reimbursement. There are many ways and methods. There is a view that it is not necessarily appropriate to directly include this antibody drug into the purchase with quantity at present. " Jin Chunlin said.

?