In 2020, with the gradual implementation of "4 + 7 procurement with volume" nationwide expansion, the medical reform will continue to tackle the difficulties, the route of deepening the reform of the medical and health system will be gradually clear, and China's biomedicine will enter the year of transformation. The era of high gross profit of generic drugs is over. In the future, innovative drugs will occupy more market space. China is gradually changing from "generic" to "innovative".
Moreover, covid-19 outbreak has also caused great impact on pharmaceutical companies, and accelerated the "big shuffle" of the pharmaceutical industry. Among them, ten key words will emerge in the pharmaceutical circle in 2020, which are the key factors affecting the development of pharmaceutical enterprises in the epidemic situation, the clarion call for the formal implementation of national policies, or the hot talk of the industry.
1. Epidemic situation
In 2020 China covid-19, no matter how strong the prophet, would not expect the new crown to drop from the clouds, and the great influence and the great influence on the international situation and China's economy.
The outbreak of the covid-19 outbreak also pushed the bio pharmaceutical industry to a public view. The whole society attaches more importance to the medical and pharmaceutical industry, the public medical resources are further expanded and enriched, and the medical system is gradually expanded and improved. Social resources have entered the medical and public health fields one after another. Diagnostic reagents and epidemic prevention materials enterprises show a blowout growth, especially in the field of diagnosis. The epidemic situation has greatly promoted the detection of nucleic acid antibodies and vaccines Most medical platforms have made phased progress in the process of R & D and other innovative R & D projects.
"A series of policies, such as accelerated approval, targeted financing support and tax incentives, have been urgently issued for enterprises in the fields of R & D of nucleic acid antibody detection, vaccine drug prevention and control, public health consumables, etc., providing a good industry development and financing environment for pharmaceutical enterprises. Enterprises with technical reserves in the early stage usher in the opportunities of the century." Professor Zhou Yong, chairman of Gaosheng biomedical, said so.
2. Traditional Chinese Medicine
With the arrival of the age of aging population and the general improvement of health awareness, the traditional Chinese medicine industry with the unique advantage of "preventive treatment of disease" has ushered in a huge development opportunity. Especially in the 2020 covid-19 outbreak, Chinese medicine played an important role, and provided a good opportunity for its industrialization development.
At present, under the great pressure from foreign "foreign traditional Chinese medicine", the export volume of Chinese patent medicine in the international market accounts for a very small proportion, most of which are occupied by Japan and South Korea. Therefore, while maintaining the traditional characteristics and advantages of traditional Chinese medicine, we should make full use of modern scientific and technological means and methods to develop a new generation of traditional Chinese medicine that meets the market demand and improve the quality of Chinese medicine The competitiveness of pharmaceutical products in the international market is one of the important research contents in the development of new drugs of traditional Chinese medicine.
With the implementation of the new drug registration management measures, the national drug regulatory department has issued a number of documents for the research and development of traditional Chinese medicine, which provide guidance and requirements for the research of medicinal materials, production technology and quality standards. The research and development of new traditional Chinese medicine is gradually moving towards the track of scientization, standardization, standardization and legalization.
3. Gene editing technology
Two foreign female scientists discovered CRISPR / cas9 gene scissors, a super tool in gene technology, and won the Nobel Prize in chemistry in 2020. Gene editing technology has once again come into people's sight and become one of the top ten hot words in 2020.
Gene editing technology is to accurately identify the target nucleotide sequence in the target cell DNA fragment, and use endonuclease protein to cut the DNA target sequence, so as to complete the accurate editing of the target cell DNA gene fragment.
At present, editas medicine, intellia therapeutics, egenesis and other companies are laying out R & D pipelines in leukemia, cancer and other fields to try to solve the mystery of gene editing and explore the mysteries of life science.
4. Centralized purchasing
In 2020, the state has carried out four rounds of centralized procurement and coronary stent centralized procurement, which has greatly reduced the cost of patients and made the people truly realize the benefits brought by the health care reform.
The scope of centralized purchasing has been constantly expanded and normalized, which has become the consensus of the industry. In the future, injection, equipment consumables, insulin and other fields are gradually included.
Industry insiders believe that the future direction of centralized purchasing may be gradually precise, or "personalized customized centralized purchasing". Considering the national medical insurance burden ratio, market size, drug classification and other aspects of a certain drug, we can subdivide different drug fields, take into account the upstream original and auxiliary packaging industry chain and downstream clinical application scope, and establish and improve the centralized purchasing policy of drugs.
5. Health care negotiations
Last December, the fifth round of health care negotiations officially ended. 162 drugs were involved in this negotiation, and 119 drugs were finally negotiated, with an average price reduction of 50.64%. Among them, 14 kinds of exclusive drugs in the catalog with annual sales of more than 1 billion yuan were successfully negotiated, with an average price reduction of more than 40%.
This time, the medical insurance catalog was adjusted to the largest scale in history, and the number of drug negotiations was also the largest, making "medical insurance negotiation" one of the top ten hot words in the medical circle in 2020.
Among them, the crown treatment drugs were all included in the medical insurance, the four domestic "Star" anticancer drugs PD-1 were all won the bid, and the four multinational pharmaceutical companies, MSD, BMS, AZ and Roche, were all defeated. Through the negotiation of price reduction and medical insurance reimbursement, it is estimated that the cumulative burden of patients will be reduced by about 28 billion yuan in 2021.
6. Evaluation of injection consistency
In May 2020, the State Drug Administration (SDA) issued an announcement to carry out the quality and efficacy consistency evaluation of generic chemical injection.
On the same day, CDE issued the technical requirements for quality and efficacy consistency evaluation of generic drugs for chemical injection, technical requirements for quality and efficacy consistency evaluation of generic drugs for chemical injection (special injection), and application data requirements for quality and efficacy consistency evaluation of generic drugs for chemical injection, which marked the official launch of injection consistency evaluation.
Industry insiders said that the consistency evaluation will reconstruct the competition pattern of generic drugs, forcing more domestic generic drug companies to transform from low-end to high-end and innovative.
7. New patent law
In October 2020, the Standing Committee of the National People's Congress voted on the decision to amend the patent law. The new "patent law" adds an early settlement mechanism for drug patent disputes, and puts forward the compensation system for the term of new drug patent right at the legislative level for the first time.
The purpose of patent linking system is to encourage the balanced development of innovative drugs and generic drugs. First, after the implementation of patent linking, generic drugs that successfully challenge patents will have the incentive of exclusive period, which in turn requires higher quality of original research drug patents and promotes patent protection of innovative drugs; second, with the patent linking system, original research drugs can contain generic drugs with patent infringement at the stage of market approval and reduce the cost of patent dispute resolution. " Said Dr Tang Huadong, partner of Beijing Zhide law firm.
The compensation system of new drug patent term is to improve the attraction of China as the first place for new drug listing, and promote the global new drugs to enter the Chinese market as soon as possible.
8、PD-1
PD-1 is an important immunosuppressive molecule, which can be used in all solid tumors by activating the body's own immune system to attack cancer. In 2018, after the first PD1 McAb o drug was listed in China, major pharmaceutical companies and national review agencies have made efforts one after another. So far, eight PD1 McAbs have been listed in China in just two years.
Among them, 2020 is the "blowout period" of PD-1 R & D, with the largest number of applications. So far, there are 364 acceptance numbers and 266 clinical applications in China, of which 46 are for production. In 2020, there are 169 acceptance numbers for registration (listing + clinical), 45 enterprises for registration, and 74 for MSD.
9. Merger and acquisition
2020 is a year of continuous M & A activities of pharmaceutical enterprises, with a total amount of 136.7 billion US dollars in the top ten M & A events in the world. Among them, AstraZeneca, the global pharmaceutical giant, acquired alexion pharmaceutical, a US biotech company, with a price of US $39 billion, becoming the largest transaction in the field of biomedicine.
In the future, with the in-depth consistency evaluation of generic drugs and the normalized development of procurement with volume, the pharmaceutical industry will usher in a new round of reshuffle, and small and medium-sized enterprises will face greater challenges. Merger and reorganization may be the best arrangement.
10. Record system of pharmaceutical representative
In June 2020, the comprehensive Department of the State Food and Drug Administration issued the measures for the administration of the filing of pharmaceutical representatives (for Trial Implementation) (Draft for comments) and solicited public opinions; in September, the State Food and Drug Administration organized the formulation and issuance of the measures for the administration of the filing of pharmaceutical representatives (for Trial Implementation) to regulate the promotion of pharmaceutical representatives; from December 1, one of the measures has been formally implemented.
In the future, the development opportunity of pharmaceutical representatives is to find new sales channels and reach the target population. Under the promotion of 2030 health planning, hierarchical diagnosis and treatment, volume procurement and other policies, the broad grassroots market will become an important position for pharmaceutical enterprises to sink in the future.
Conclusion:
Novel coronavirus pneumonia and vaccine become the hot topic of the whole year in 2020. This year, with the launch of Xinguan vaccine, the epidemic situation has been gradually controlled, the domestic economic development has returned to the right track, and the pharmaceutical industry will fully recover.
In the future, the combination of national health care reform policies such as consistency evaluation and centralized purchasing policy will also force pharmaceutical enterprises to go out of the comfort zone, further improve their product R & D capabilities, make their products distinctive and enhance their competitiveness.
