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2021 is the first year of the country's "14th Five-Year Plan" and a new starting point for a century-long journey
.
This year, the global anti-epidemic became normalized, and China’s various new crown vaccines won the world’s reputation; this year, the pharmaceutical industry chain has moved towards the high end, and innovation and transformation have been comprehensively advanced; this year, new policies such as basic drugs, centralized procurement, and national talks have The structure of production and sales pattern, risks and opportunities coexist; this year, China's new drug research and development pattern from "new in China" to "new in the world" gradually formed, and a large number of innovative products continued to emerge
At the end of the year and the beginning of the year, take stock of the hot topics in the innovative pharmaceutical industry in 2021
.
01.
The number of drug approvals hit a new high , and a variety of domestic new drugs delivered satisfactory answers
Since 2021, domestic innovative drugs have been in full bloom, bearing fruit and attracting much attention! With the continuous acceleration of the review and approval of new drugs, the support of the major scientific and technological projects of "Major New Drug Creation", and the national key R&D plan, a batch of new drugs with obvious clinical value and meeting urgent clinical needs have been successfully launched to meet the clinical needs of the public.
.
According to statistics, there are 63 new drugs approved by the State Food and Drug Administration in 2021.
There are many domestic new drugs such as orabatinib, tetacept for injection, and akirenza injection
.
Among all new drugs, in addition to anti-tumor drugs accounting for the majority, there are also some new drugs for the treatment of type 2 diabetes, systemic lupus erythematosus, rare diseases and other diseases
With the continuous strengthening of independent research and development capabilities of local pharmaceutical companies, the coverage of indications is expanding, and the speed at which innovative drugs are approved for marketing has increased significantly
.
02.
The new version of the "Patent Law of the People's Republic of China" was officially implemented
The new version of the "Patent Law of the People's Republic of China" ushered in the fourth amendment after 2008, and will come into force on June 1, 2021
.
For a special product with huge investment in research and development, this revision of the Patent Law provides stronger protection of property rights
Other new additions include improving the patent authorization system, further improving the relevant systems for design protection, and extending the term of design patent protection to 15 years
.
At the same time, the compensation for patent infringement has been increased, and a punitive compensation system has been added.
03.
The "magic" document that the stone from other mountains can attack the jade vibration industry is implemented
In 2021, CDE will issue and implement a total of 87 related technical guidelines.
These guidelines not only further improve the domestic technical guidelines system, but also facilitate the scientific and rational research of developers and improve the efficiency of research and development
.
On July 2, 2021, CDE issued a notice on the public solicitation of opinions on the "Guidelines for Clinical Research and Development of Antitumor Drugs Oriented to Clinical Value" ("Draft for Comment")
.
The "Draft for Comments" emphasizes that the concept of patient-centered anti-tumor drug research and development is not only reflected in the needs of patients, feedback, information collection, analysis and methodological improvement, but also from determining the direction of research and development to conducting clinical trials.
In November, the "Guiding Principles for Clinical Research and Development of Antitumor Drugs Oriented to Clinical Value" was officially released.
The introduction of the guiding principles will have a long-term impact on the future development of the entire innovative drug and CXO industry.
Value-oriented, the core value concept of solving unmet clinical needs has been affirmed by all parties
.
The guiding principles clearly mention that when conducting controlled clinical trials of drugs, firstly, the best treatment methods/drugs in clinical practice should be provided to the subjects; secondly, the highest goal of new drug development should be to provide patients with better treatment options.
04.
The research and development of the new crown vaccine allows the world to witness the speed of China!
In early 2021, a variety of new crown vaccines developed by China have been launched one after another, providing a powerful weapon for fighting the epidemic
.
On February 5, Kexing Zhongwei's new coronavirus inactivated vaccine (Vero cells) was approved for marketing with conditions, and it took only 3 days from the submission of the marketing application to the approval
On February 25, the State Food and Drug Administration approved the registration application of the new coronavirus inactivated vaccine (Vero cells) of Sinopharm China Bio-Wuhan Biological Products Research Institute Co.
, Ltd.
with conditions
.
The approved indication is for the prevention of disease caused by novel coronavirus infection (COVID-19)
On February 25, CanSino Bio's recombinant novel coronavirus vaccine (type 5 adenovirus vector) was approved for marketing with conditions
.
The vaccine is the first domestically produced adenovirus-vectored new coronavirus vaccine and is suitable for the prevention of disease (COVID-19) caused by new coronavirus infection
.
The protection rate after 28 days of single injection was 65.
28%, marking a breakthrough in another technical route other than inactivated vaccines
.
In addition, in order to meet the needs of various countries in the world, especially developing countries, for the new crown vaccine, China has actively carried out international cooperation on vaccines and officially joined the "New Coronary Pneumonia Vaccine Implementation Plan".
and affordability
.
China's vaccine has become a "lifeline for developing countries"
05.
The dynamic adjustment of the medical insurance catalogue is gradually normalized with the approval and discussion
In 2021, the national basic medical insurance drug list will be adjusted again, a total of 74 drugs will be added to the list, and 11 drugs will be removed from the list
.
The newly included drugs accurately fill the needs of drugs for tumors, chronic diseases, anti-infections, rare diseases, women and children, involving a total of 21 clinical groups
.
In 2021, the total number of drugs in the National Medical Insurance Drug List is 2,860, which will be implemented on January 1, 2022
.
The first challenge for new drugs to enter the NRDL is price reduction
.
Whether the market value and investment of innovative drugs can be satisfied has also become the focus of the market
.
It is worth mentioning that there are 23 major national innovative drugs that have entered into negotiations this year, of which 22 have successfully entered the National Medical Insurance List, and the average period from approval for listing to inclusion in the Medical Insurance List is one year and two months
.
According to the statistics of China Pharmaceutical Innovation Promotion Association, a total of 21 drugs were included in this negotiation from its 16 member units, of which 11 will be listed in 2021, accounting for 52.
4%.
In progress
.
06.
The centralized and volume-based procurement of medicines is moving towards normalization
On February 3, 2021, the National Medical Insurance Bureau organized the fourth batch of national centralized drug procurement work
.
All 45 drugs to be purchased were successfully purchased, and the average price of the selected drugs was reduced by 52%
.
The state's organization of centralized drug procurement is a major reform of the previous centralized drug procurement system
.
This centralized procurement work is a successful practice under the guidance of the "Opinions on Promoting the Normalization and Institutionalization of Centralized Drug Procurement with Volume" (hereinafter referred to as the "Opinions") promulgated by the General Office of the State Council, marking China's centralized drug procurement system.
It has basically taken shape and achieved phased results, the orderly market competition mechanism has been fully brought into play, the institutional system is exerting synergy, and a new step in the normalization and institutionalization of the drug procurement system has been taken
.
With the deepening and development of the reform of the centralized drug procurement system with volume, centralized procurement with volume will become the dominant mode of pharmaceutical procurement in public medical institutions
.
In the future, we will continue to explore innovative centralized procurement methods, and focus on centralized procurement of varieties with strong universality according to unified rules; continue to promote high-value medical consumables according to "one product, one policy"; explore special centralized and volume-based procurement for highly characteristic varieties ; Exploring combined purchases for varieties with similar indications and functions; Exploring purchases through staged bargaining for large changes in the supply and demand relationship
.
At the same time, the categories of centralized procurement have also expanded from chemical drugs to biological drugs, high-value medical consumables,
etc.
Procurement with volume has become the baton of corporate actions.
Under centralized procurement, generic drugs have entered the era of meager profits.
How to break through and transform has become a life-and-death problem in front of them
.
07.
The State Talks dual-channel landing to open up the "last mile" of accessibility
The "Guiding Opinions on Establishing and Improving the "Dual Channel" Management Mechanism for National Medical Insurance Negotiated Drugs" jointly issued by the National Medical Insurance Administration and the National Health and Health Commission proposes that retail pharmacies will be included in the scope of negotiated drug supply guarantees and designated medical institutions to form a "dual channel" for negotiating drug reimbursement.
channel"
.
As of the end of the year, Zhejiang, Shanghai, Hebei, Guangdong, Anhui, Hunan, Jiangxi, Guangxi and many other places have completed the "dual-channel" management of drugs in China
.
08.
High-value drugs for rare diseases entered medical insurance for the first time to achieve zero breakthrough
In December 2021, the National Medical Insurance Bureau officially released the "Notice on the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2021)", two heavy rare disease drugs: Nosinagen Sodium Injection, Fampridine Releasing tablets (Fubineng) all appear in the adjusted list of medical insurance drugs
.
The adjusted medical insurance drug reimbursement catalog has been implemented since January 1, 2022.
This move will greatly improve the predicament of tens of thousands of SMA and MS patients in China who suffer from heavy treatment burdens and severely impaired quality of life, and will also bring more patients with rare diseases.
come to hope
.
The road of innovation will always be bumpy.
After various baptisms in 2021, the biopharmaceutical industry is reborn
.
On the train to 2022, the pain of transformation and the embrace of innovation will be the necessary stages for China's pharmaceutical industry to go into the future and go international
.
It's time for medical innovation, and we should be more focused than ever
.
References:
References:Yaodu database
Yaodu databaseAn article to understand the new crown vaccines approved in China and around the world (Drug Times)
An article to understand the new crown vaccines approved in China and around the world (Drug Times)just! The results of the fourth batch of drug centralized procurement are announced! An average price reduction of 52%! (China Pharmaceutical News)
just! The results of the fourth batch of drug centralized procurement are announced! An average price reduction of 52%! (China Pharmaceutical News)Announcement of the adjustment results of the National Medical Insurance Drug List in 2021: 74 new drugs are added (The Paper)
Announcement of the adjustment results of the National Medical Insurance Drug List in 2021: 74 new drugs are added (The Paper)
