Reduce prices and control fees throughout the policy-oriented drive innovation and development of enterprises

Looking back on the past year, we are still undergoing the test of the new crown pneumonia epidemic, but the pharmaceutical business has not stalled, and the overall development of China's pharmaceutical companies has maintained a rapid growth trend
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Statistics show that in the first three quarters of 2021, the operating income of pharmaceutical companies above designated size in China reached 2,219.
1 billion yuan, a year-on-year increase of 24.
4%; total profits reached 452.
53 billion yuan, a significant year-on-year increase of 80.
6%
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The rapid development of any industry is inseparable from policy support
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Since 2015, the Food and Drug Administration, the State Council, etc.
have continuously introduced new policies involving the research and development, review, registration, production, and post-market payment of innovative drugs
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By 2021, the first year of the Fourteenth Five-Year Plan, China's medical industry has undergone a series of policy adjustments, the framework has basically taken shape, and the overall policy for drug access, pricing, procurement, use, and payment has been determined
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Lowering prices and controlling fees and encouraging innovation have been the main keynotes of medical policies in recent years
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The policy trend this year is still the same.
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1.
The 14th Five-Year Plan: The path of medical reform is clearer.
2021 is the starting year of the 14th Five-Year Plan
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On March 13, the Central People's Government website announced the "Fourteenth Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Outline of Long-Term Goals for 2035" (hereinafter referred to as the "14th Five-Year Plan")
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As a programmatic document to guide China's national economic and social development in the next 5 and 15 years, it has embarked on a grand blueprint for China's new journey
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The 14th Five-Year Plan stated in the section on deepening the reform of the medical and health system to promote the reform of the centralized procurement and use of drugs and consumables organized by the state, and to develop high-end medical equipment
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This shows that the national level is determined to normalize volume procurement
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The plan also stated that it will improve the rapid review and approval mechanism for innovative drugs, vaccines, medical devices, etc.
, speed up the review and approval of urgently needed clinical drugs and rare disease treatment drugs and medical devices, and promote the urgent clinical need for new drugs and medical devices that have been marketed overseas to be listed in China as soon as possible
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This will not only accelerate the landing of foreign innovative drugs in China, but local innovative products will also develop rapidly
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In addition, the 14th Five-Year Plan also includes a series of medical insurance systems that benefit the people, which will effectively squeeze the water consumption of medicines, reduce the burden on the people, purify the ecology of the industry, and standardize medical behavior
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The development path of China's medical reform is gradually becoming clear
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2.
Volume procurement has expanded to various fields, and foreign investment has begun to embrace.
For a long time, China's pharmaceutical industry has had problems such as high prices and irregular circulation, which have increased the burden of patients on medication
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In November 2018, 11 cities including Beijing and Shanghai adopted the "quantity-for-price" trial to start centralized drug procurement ("4﹢7" volume procurement)
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Subsequently, this model rapidly expanded to the whole country, from the "4+7" centralized procurement to the expansion of centralized procurement, the second batch, the third batch.
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Now a total of six batches and seven rounds of centralized procurement have been carried out
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Recently, it was also reported that the seventh batch of eight rounds of national volume procurement special communication meetings had been organized in Shanghai on December 23
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[Related reading: Seven batches and eight rounds of national procurement communication meetings were held, and the forecasting rules were adjusted in three aspects] 1.
The first five batches of the first five batches of chemical drugs in the mass procurement that have been carried out for the first five batches of chemical drugs, a total of 218 The price of the selected products dropped by an average of 53%; the sixth batch is the special purchase of insulin, which is the first time that the “national team” of centralized drug procurement has expanded into the field of biological drugs.
"Boots landing" involved 234 varieties, of which 16 were selected
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In the two rounds of centralized procurement organized this year:-The fifth batch of national centralized procurement of 61 selected drugs, the highest drop was 98%, and the average price drop was 56%
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Among them, 240 products were selected by 138 domestic companies, and 11 products were selected by 10 foreign-funded companies.
Compared with the previous batches of centralized procurement, the number of selected Chinese and foreign-funded companies in the fifth batch of centralized procurement has increased significantly.
The highest concentration of national drug procurement
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In addition, compared with the previous centralized procurement of chemical drugs, this centralized procurement not only involved the largest number of varieties, but also the highest purchase amount, with the highest proportion of injections.

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——The sixth batch of national centralized procurement included a total of second- and third-generation insulins, and the annual purchase volume reached 210 million
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In the end, a total of 42 varieties of 11 companies were selected, with an average drop of 48.
74%
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This centralized procurement was the first time that biosimilars participated in the national centralized procurement.
The decline was relatively mild, and it was the smallest decline in the past
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Among the foreign “giants” of insulin, Novo Nordisk, Eli Lilly, Baitong, and Sanofi have won the bids for 7, 5, 3, and 2 products respectively
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[Related reading: Official announcement of the results of insulin national procurement! The highest drop was over 70%.
Ganli Pharmaceutical and Yifan Pharmaceutical rose sharply] 2.
Local alliances have targeted Chinese patent medicines for centralized procurement.
In addition to centralized procurement of Chinese patent medicines this year, there are two large inter-provincial alliances targeting Chinese patent medicines.
Launched centralized procurement-Hubei 19 Provincial Union and Guangdong 6 Provincial Union
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Previously, due to the large number of exclusive products, the high degree of concentration, the inability to use consistency evaluation as a quality evaluation system, and the difficulty in defining the cost of Chinese medicinal materials of different quality, proprietary Chinese medicines have always been a difficulty in centralized procurement
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At the beginning of this year, the General Office of the State Council issued the "Opinions on Promoting the Normalized and Institutionalized Development of Centralized and Volumetric Procurement of Drugs", which clearly "explored the merger of different generic drugs with similar indications or functions and indications to carry out centralized and volumetric procurement.
" With policy support, two inter-provincial alliances for centralized procurement of Chinese patent medicines came into being
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This month, the results of the centralized procurement of proprietary Chinese medicines in Hubei showed that 182 products from 157 companies participated in the quotation, with a procurement scale of nearly 10 billion yuan
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97 companies and 111 products were selected, the selection rate reached 62%, the average price of the selection fell by 42.
27%, and the largest drop was 82.
63%
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The selected products have complete dosage forms and specifications, and most of the mainstream products currently in clinical use are selected, which can effectively meet the needs of clinical and normalized epidemic prevention and control drugs
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According to the calculation of the annual demand of the 19 provincial alliances, it is estimated that more than 2.
6 billion yuan of drug costs can be saved each year
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In addition, the collective procurement work of the Guangdong 6-province alliance has also come to an end, and is about to enter the final bidding stage.

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However, at present, several provinces overlap between the two alliances, and some centralized procurement products also overlap.
The solution has yet to be announced
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3.
Centralized procurement of high-value medical consumables continues to "strengthen" As in the medical field, the problem of inflated prices in the field of medical consumables cannot be ignored
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Last year, the heart stent fired the first shot in the centralized procurement of consumables, and 10 products from 8 companies were selected
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The average price of coronary stents dropped from about 13,000 yuan to about 700 yuan, an average drop of 93% compared to 2019
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In this year's orthopedics takeover, the second batch of national high-value consumables (bone joints) collection ended
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The average price of the artificial hip joints to be selected dropped from 35,000 yuan to about 7,000 yuan, and the average price of artificial knee joints dropped from 32,000 yuan to about 5,000 yuan
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The procurement of high-value consumables with volume is expanding in an orderly manner, and the price of medical consumables will be further squeezed
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Summary: Now that centralized procurement has passed its 3rd anniversary, the scope of implementation has been expanded from 11 cities to the whole country, and the procurement content has expanded from oral dosage forms to injection dosage forms, from chemical medicines to biological medicines, and may expand to Chinese patent medicines and original research medicines in the future.
The number of selected selections has gradually increased from the initial single digit to the double digits of the two batches of centralized procurement this year, and foreign companies have begun to embrace centralized procurement
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The collection of consumables has also expanded from the heart stent to the orthopedics field
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This means that in the future, various types of drugs and high-value consumables will enter the centralized procurement as long as they meet the conditions
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3.
Medical insurance catalogue: the high-priced rare disease drugs achieved a breakthrough.
On December 3, the 2021 version of the National Medical Insurance Catalogue was released.
The total number of drugs in the adjusted national medical insurance drug catalogue was 2,860, and a total of 74 drugs were added to the catalogue, which were included in the list after negotiation 67 kinds, with an average drop of over 61.
7%, 7 kinds of drugs were directly transferred; 11 kinds of drugs were transferred out of the catalog and will be implemented on January 1, 2022
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[Related reading: 2021 National Medical Insurance Catalogue announced! Hengrui's PD-1 new indications have not been introduced, the imported PD-(L)1 is completely wiped out, and the negotiations for the price reduction of Bojian's high-priced drugs are successful! (Full list attached)] Anti-cancer drugs have always been a hot topic in medical insurance negotiations, but this year, "not giving up every small group" has become a new bright spot, and it continues to be on the hot search: once 700,000 injections The sky-high price of the drug-Bojian SMA (spinal muscular atrophy) treatment drug Noxinasheng Sodium Injection was finally reduced to about 33,000 yuan
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Since its establishment in 2018, the National Medical Insurance Bureau has carried out the adjustment of the national medical insurance drug catalog for the fourth consecutive year.
A total of 507 drugs have been added to the scope of national medical insurance payment, and a batch of "magic drugs" and "zombie drugs" have been transferred out Directory
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"Soul bargaining" one after another has brought hope of rebirth to more and more families of patients
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However, medical insurance negotiations are different from centralized procurement, which has a positive effect on the sales of innovative drugs.
The rapid increase in volume while reducing prices is also conducive to leading innovative drug companies and Biotech companies that lack commercialization capabilities to quickly recover R&D costs and accelerate the development of new pipelines
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Looking back at previous medical insurance negotiations-in 2020, 119 new drugs will be added, with an average price drop of 50.
6%; in 2019, 70 new drugs will be added, with an average price drop of 60.
7%; in 2018, medical insurance negotiations will include 17 anti-cancer drugs, with an average drop 56.
7%; In 2017, 44 varieties were in talks, and finally 36 varieties were successfully negotiated to be included in medical insurance, with an average decrease of 44%
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(Led by the Ministry of Human Resources and Social Security) .
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It is worth mentioning that in 2017, it usually takes 4 to 9 years for a new domestic drug to enter the medical insurance from the launch of the new drug.
By 2020, the time from the launch of the new drug to the medical insurance will be shortened to 0.
5 Years to 5 years
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As the product terminal volume is significantly faster after entering the medical insurance, and the time to enter the medical insurance is greatly shortened, some innovative drugs directly enter the medical insurance after the market, which also further encourages pharmaceutical companies to develop new drugs
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The rapid increase of new drugs after entering the medical insurance also allows pharmaceutical companies to focus more on drug research and development rather than on the sales side
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4.
The reform of medical insurance payment is carried out from a pilot program to the whole country.
Similarly, the payment method of medical insurance has ushered in important changes this year
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On November 26, the National Medical Insurance Administration issued the "Notice on Printing and Distributing the Three-Year Action Plan for DRG/DIP Payment Method Reform
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" The document emphasizes that by the end of 2024, all coordinated areas across the country will carry out the DRG/DIP payment method reform.
By the end of 2025, the DRG/DIP payment method will cover all eligible medical institutions that carry out inpatient services, and basically achieve full disease and medical insurance funds.
Covered
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On December 17, the official WeChat account of the National Medical Insurance Administration issued a notice on the list of DRG/DIP payment demonstration sites, including 18 DRG demonstration sites, 12 DIP demonstration sites, and 2 integrated (DRG/DIP) demonstration sites, covering a total of 32 Three cities (including the three municipalities directly under the Central Government of Beijing, Tianjin and Shanghai, six sub-provincial cities including Shenyang, Harbin, Qingdao, Wuhan, Xiamen, and Guangzhou, and the rest are prefecture-level cities)
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The DRG/DIP payment model has changed from pilot cities to demonstration cities this year, and the next step is to replicate and promote the DRG/DIP reform across the country
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Nowadays, medical insurance payment is the main source of income for hospitals, that is, the payment method of medical insurance funds directly determines the hospital’s attitude towards diagnosis and treatment items, and affects the nerves of hospital administrators
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The reform of the DRG/DIP payment method from the pilot to the whole country means that the logic behind the entire medical market from access to clinical use to medical insurance reimbursement will be redefined
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The development route of aggressive expansion in the past suddenly became "not popular", and "refined management", "disease cost control", "improving the quality of medical records", and "optimizing disease structure" have become hot topics among hospital managers
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For pharmaceutical companies, their marketing thinking needs to be changed
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This has put forward new requirements for medical representatives.
It is not enough to understand their own products.
They have to make up lessons on the overall market situation and the calculation of medical insurance costs
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After the failure of "promotion lubricant", medical representatives will further return to the foundation of their profession, and the professionalism of medical promotion will be further improved.

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In addition, under the control of DRG/DIP fees, products that are expensive and easily replaced in the future will be gradually screened out and eliminated
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And irreplaceable innovative products, products with mature technology and reasonable prices, their dominant position will also be more prominent
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5.
Children's medicines are added to the list of essential medicines.
The innovation and standardization of pediatric medicines are on the line.
On November 15, the National Health Commission issued an announcement on the public consultation on the "National Essential Medicines List Management Measures (Revised Draft)"
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Compared with the 2015 edition of the Essential Medicines List, the revised "National Essential Medicines List Management Measures" emphasizes that the management of the list of medicines should first be based on the needs of clinical practice; and the children's medicines are listed separately, clarifying that children's medicines are mainly classified according to children's specific applicable medicines
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In addition, in principle, the revision of the management measures will change the adjustment cycle from "adjusted once every three years" in principle to "no more than 3 years"
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Children's medicines in our country have been facing problems such as fewer special varieties, fewer suitable dosage forms, and irregular use of drugs
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In 2011, 15 large-scale children's medical institutions nationwide surveyed the use of children's drugs.
Among the 1,098 drugs in the pediatric drug common catalogue of 15 hospitals, only 45 (4.
10%) of children's drugs were used, which was less than half of the usage and dosage for children
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Ten years later, the development of children's medicine is still not ideal
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In recent years, China has paid more and more attention to the problem of children's medication.
The national government departments have successively issued a series of relevant policies and regulations to encourage the research and development of children's medications, and select and review relevant policies and regulations-September, in order to solve the shortage of clinical children's medications, encourage drug developers To develop dosage forms and specifications suitable for children, the Center for Drug Evaluation has organized and formulated the "Guiding Principles for Clinical Trials of Modified New Drugs for Children's Chemicals (Trial)"
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In July, in order to encourage the innovative research and development of children's medications, optimize the efficiency of children's medication communication and acceptance review, and improve the records and statistics of children's medication information, CDE issued the "Notice on Regulating Applicants' Children's Medication Application Information Remarks.
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On Children’s Day (June 1), the Drug Evaluation Center of the State Medical Products Administration opened a "Children’s Medication Column" to centrally disclose policies, regulations, guidelines, and training materials related to children’s medication
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In May, the Drug Evaluation Center of the State Food and Drug Administration issued a notice to solicit opinions on the "Technical Guidelines for the Writing of Children's Drug-Related Information in the Instructions for Chemical Drugs and Therapeutic Biological Products (Draft for Solicitation of Comments)" to promote the orderly development of enterprises Drafting and perfecting the work related to children's medication information in the drug insert
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……Not only in the use of drugs, but also in children's testing is gradually establishing standards
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With the "Reference Intervals for Children's Blood Cell Analysis" and "Reference Intervals for Commonly Used Children's Clinical Biochemical Test Items", the two health industry standards have been formally implemented nationwide since October 1 this year, and China's children's blood test finally has an exclusive reference interval
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6.
The New Deal attacked "me worse" innovative pharmaceutical companies and CXO went down.
On November 19, CDE issued six important documents in a row
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Among them, the most concerned by the industry is the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines", which establishes the clinical value-oriented drug development-oriented technical principle in the field of anti-tumor drugs, and establishes a patient-centric approach.
The concept of research and development
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As soon as the draft for comments in July this year was released, it set off a huge wave in the secondary pharmaceutical market, to a certain extent, "squeezing out" the valuation bubble of innovative drugs
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Take the A-share market as an example.
At that time, as many as 12 stocks fell by more than 10%, and 59 stocks fell by more than 5%.
Many CRO/CMO/CDMO stocks fell sharply
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Innovation has always been the biggest pain point and difficulty in the domestic pharmaceutical industry
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Since 2015, the number of clinical trials registered in China has increased exponentially.
In 2018, the number of domestic clinical trials even exceeded that of the United States and Europe
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However, the quantity cannot determine the quality
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The current domestic clinical trials of innovative drugs have the problem of repeated research and development of a large number of popular targets, which has aggravated the situation of domestic clinical trial resources being tight
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The clustering of domestic innovative drug targets, the proliferation of "me-too", low-level duplication, etc.
are not innovations advocated by policies, and CDE's New Deal is aimed at these problems
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In the future, some scattered, inefficient, and repetitive low-level innovations will gradually withdraw from the stage of history
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At the end of 2021, Sina Pharmaceuticals will have a special dialogue with practitioners in the affected fields to interpret the ecological changes in the industry brought about by this policy.
To read more, please click: "Special Dialogue at the End of 2021｜Biotech, MNC, CRO.
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from multiple perspectives The "CDE Anti-tumor Drug New Deal" changes
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" The pharmaceutical policy has led the industry to undergo several changes, running through the entire history of pharmaceutical development
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Driven by policies, only "changes" can pharmaceutical companies adapt to the new normal
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Innovation is the eternal melody
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