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Although many people do not want to, the New Year's bell in 2023 is likely to ring in a search for medicine
.
In the past two days, all over the various WeChat groups and friend circles, all of them are seeking news about the new crown oral medicine channel
.
A prescription drug that has only been on the market for less than two years, and has not even undergone in-hospital academic education, has become a product that people across the country are chasing in a race to, on the one hand, it shows that the new crown epidemic is more serious than imagined - when the large base is infected, the real severe disease occurs around; On the other hand, the private circulation of this prescription drug during this period also shows that the construction of medical diagnosis and treatment system and drug channels has a long way to go - of course, the short-term large-scale outbreak of new crown infection has caused a violent impact
on the existing conditions.
Because of the "education" of the epidemic, this year's new crown oral medicine has been speculated from the beginning of the year to the end of
the year.
And perhaps too much to give way to the prevention and control of the new crown epidemic, the normal pharmaceutical industry has also suffered to a certain extent
.
According to the National Bureau of Statistics, from January to October this year, the national pharmaceutical manufacturing industry recorded revenue of 2,324.
7 billion yuan, down 2.
1% year-on-year, and the cumulative profit was 349.
63 billion yuan, down 29.
3%.
This is the worst data
after the nationwide shutdown in the first quarter of 2020.
In addition to the epidemic, the suppression of profit margins brought about by the two major price limit policies of volume procurement and medical insurance negotiation, and the influence of international macro environmental factors such as global decoupling and US dollar interest rate hikes this year, the prosperity of the pharmaceutical industry in the capital market has been declining all the way - the proportion of public funds in pharmaceutical stocks is close to a record low
in ten years.
in a decade.
The capital market is more of an emotional field and a vane
for the industry.
In the past year, in addition to the related sectors represented by new crown oral drugs, most of the pharmaceutical subdivisions are still in a year
of valuation digestion.
After the valuation bubble is digested, it will not immediately usher in a new round of growth
.
After a trough, people tend to take a long time to stop and reflect.
In the face of the past year, standing under a new threshold, whether it is from the strategic reports of securities companies or the views that occasionally emerge from the public opinion field, the entire pharmaceutical industry seems to have less expectations and more rational helplessness
than in previous years.
-01-
-01-Supply-side reform of innovative drugs
Supply-side reform of innovative drugsWhether it is Pfizer's P drug or a large number of domestic followers, the new crown oral drug belongs to the category
of "innovative drugs" that we have shouted for a long time in the past.
The so-called innovative drugs, high barriers to entry, long development cycles, high input costs, and of course rich returns - Pfizer's two new crown products, vaccines and oral drugs, recorded sales of $36.
7 billion (2021) and $22 billion (expected in 2022) in the past year, respectively, a figure that has surpassed the sales
of any so-called "blockbuster" in the past 100 years.
In the past, China relied on top-down administrative reform to solve the problem of "high barriers, large investment and long development" of innovative drugs, making China's new drug development level among the
world's top lines.
The "high return" has attracted a large number of players to follow, and the entire innovative drug industry has also formed a fierce competition situation because too many players squeezed in, so that the top-level design has also cooperated with relevant departments in the past two years to solve the problem of "high return", and the irrational heat of the industry has slowly subsided
.
As soon as the top layer shot, the heat rose quickly and fell quickly
.
This year has been called the winter year
of innovative drugs by all investors and practitioners.
But despite the cold winter of innovative drugs this year, the entire industry still handed over a good level of
answers.
answers.
In 2022, the NMPA approved a total of 41 new drugs (32 last year); In terms of commercialization, despite the price reduction of medical insurance, the commercialization of innovative drugs in the first half of this year exceeded 17 billion yuan (35.
2 billion yuan in the whole of last year), and the head biotech commercialization team has basically taken shape; BD deals reached a new high across the board in terms of volume and amount (38 VS
13), the process of internationalization has been further accelerated
.
The past year 2022 was actually a year
of comprehensive improvement of the quality of China's innovative drugs.
of comprehensive improvement of the quality of China's innovative drugs.
On the approval side, since the issuance of the "Guidelines for Clinical R&D of Antitumor Drugs Oriented by Clinical Value" in July 2021, CDE has improved the two quality improvement documents
on this basis: the "Technical Guidelines for Applicability of Single-arm Clinical Trials to Support the Marketing Application of Antitumor Drugs" and the "Technical Guidelines for Patient-Centered Clinical Trial Design (Draft for Comments)".
In addition, CDE is also issuing guidelines at a weekly frequency to accelerate the process of new drug approval, making the review more efficient and
methodical.
Under the improvement of rules, it plays more of a warning role
.
In the past, China's clinical success rate was "close to 100%", and under this circumstance, pharmaceutical companies have become unscrupulous in their clinical development, as if as long as money is thrown at resources, there will be positive data
.
In the past two years, companies represented by Bio-Thera have dared to stand up and declare their clinical failures, which in a sense can promote the efficiency of
clinical research resources.
Taking a step back, there is no failure, and the casual "success" of innovative drugs is meaningless
.
This year, Daiichi Sankyo 8201 changed Her2
In the competitive landscape of the field, Hengrui very knowingly stopped the overseas clinical trial of pyrrotinib, which is actually a small progress
in the field of innovative drugs in China.
Because the development of innovative drugs should be a process of rapid trial and error, rapid iteration, one direction is not good, immediately the next, dragging on clinical, management and scientific research resources is a waste
.
The policy on capital has not been tightened, and even liberalized: 18A and the fifth set of rules of the science and technology innovation board have not changed, and the Hong Kong Stock Exchange has also launched 18C on the basis of 18A, and the threshold
for listing unprofitable innovative device companies has also been lowered.
This year, the China Securities Regulatory Commission also issued a new rule for venture capital funds: it launched the pilot work of private equity venture capital funds to allocate shares to investors in kind to further release liquidity, which means that after the lock-up period has passed, primary funds do not need to overly consider the period problem, and play a more supportive role
in long-term projects such as innovative drugs.
To encourage innovative drugs, policy encouragement is not intermittent
.
The development of innovative drugs is a medium- and long-term grand strategy, but policies will not brainlessly push the whole society forward, and correcting deviations is also part of the
encouragement.
Supply-side reform is the only way
to long-term development.
The most pessimistic time for innovative drugs has passed, and paying attention to the products in their pipeline, as long as they have certain clinical value, will eventually have their own living space
.
.
-02-
-02-The era of big health care is slowly passing
The era of big health care is slowly passingAs of this year, the seven batches of national drug centralized procurement have covered 294 varieties, and more than half of the 500 varieties have passed since the procurement of 500 varieties, but the capital market has begun to choose forgiveness
for the centralized procurement.
In September, the special treatment notice for dental implant prices, which had been brewing for nearly a year, landed
.
After this policy, which was understood by the market as "centralized procurement of dental implants", came out, because the guidance price was higher than expected, it directly set off the tide of the dental sector in the two major markets of A+H
.
Centralized procurement is still the original centralized procurement, but this time, the market has chosen to actively support
.
Also in September, the national centralized procurement of orthopedic spine consumables opened bids, and the average price fell by 84%, but the A-share Wego shares, Dabo Medical, and Chunli Medical, the same interpretation of the price limit board after the limit board, as if the centralized procurement was specially set
up for domestic orthopedic enterprises.
The degree of price reduction of orthopedic collection this time is not inferior to the 4+7 of that year, but the market chose to understand
.
In October, the centralized procurement of liver function biochemical reagents, or only regional centralized procurement, or only a draft for comments, the market has also been unable to hold back, the entire in vitro diagnostic plate directly burst out, the market is no longer "forgive" for centralized procurement, but actively embraced
.
In November, the price of coronary stent collection and renewal did not fall but increased, which injected great confidence
into the entire mature drug market.
For a while, collective procurement seemed to be the savior of pharmaceutical stocks.
.
.
Since the establishment of the Medical Insurance Bureau in 2018, the focus of medical reform has shifted to leveraging reform for the payment side, and the macro policy of medicine has entered the era of large medical insurance, directly targeting the squeeze-out reform of intermediate costs, reshaping the circulation system of the entire pharmaceutical product, and pointing to the unreasonable pricing
of pharmaceutical products.
However, in recent years, medical insurance has also slowly found a balance
between complete cost control and hospital enthusiasm, as well as corporate retention profits.
The reduction rate of centralized procurement and the institutional design are becoming clearer and more rational.
between full cost control and hospital enthusiasm, as well as corporate retention.
The reduction rate of centralized procurement and the institutional design are becoming clearer and more rational.
Feedback to the capital market, the pressure on the payment side is becoming more and more acceptable
.
When the lower limit of a track valuation is established, the probability of a repair market will be presented later
.
Generic drugs & mature drugs are the basic plate of a country's medical resources, which determines the lower limit of the health level of a region, so generic drugs will never be swept into the trash can of history, but are one of the key factors in the improvement of
life expectancy.
Feedback to the pharmaceutical industry, due to high demand and stable profitability, generic drugs & mature drugs will continue to play a fundamental role
in the cash flow of the pharmaceutical industry.
In the future, it will enjoy higher valuations with changes in domestic drug penetration, the proportion of medical GDP, and the cost reduction brought about by large-scale manufacturing
.
Centralized procurement, medical insurance negotiation, is also to exchange price reduction for access in another sense, just another version of centralized procurement
.
In fact, this year has also begun to move
in a moderate direction.
Although the medical insurance negotiations have been postponed this year, from the perspective of the renewal rules and the focus of the negotiations that have been reported earlier, this year's medical insurance has abandoned the goal of bargaining, and the focus is on accessibility and wide coverage
.
.
In fact, this year has also begun to move
in a moderate direction.
Whether it is centralized procurement or medical insurance, it is to leverage the reform of drug costs from the pricing side - directly removing the cost space outside the clinical value, so as to reduce the unreasonable use
in the hospital.
However, both policies this year show that the medical insurance bureau's exploration in this direction has basically reached the extreme
.
The highlight of the "14th Five-Year Plan" on medical reform lies in the price reform of medical services represented by DRG/DIP, and the centralized procurement of this method of directly removing the premium space, and the standardization of medical service prices is linked to clinical value, and at least gives drugs and services a certain premium space
.
Policy formulation requires greater
efforts to solve the most serious problems.
Once the situation eases, it will be more refined and gradual
.
In the past, the medical insurance fund took balance and retention as KPIs, and continuously deepened the profit suppression of innovative drugs and mature drugs, but now, the balance rate of the national basic medical insurance fund is constantly rising, which also puts forward new requirements
for the efficient use of medical insurance funds.
for the efficient use of medical insurance funds.
Therefore, in the next two to three years, the price suppression without a bottom line is likely to be put into the trash can
of history in the short term.
-03-
-03-New faces, new opportunities
New faces, new opportunitiesAlthough the pharmaceutical industry has repeatedly emphasized "internationalization", one concept that cannot be avoided in the 14th Five-Year Plan is domestic demand
.
No matter how fragrant the flowers are outside the wall, the pharmaceutical industry is always a highly rigid domestic demand-oriented industry
.
Even if the pharmaceutical industry is strong in the United States, the core is because the United States itself has the highest demand for drugs in the world, and the spillover of the American pharmaceutical industry is only an adjunct
to the huge domestic demand.
India is also, India's generic drug industry is the world's first is not its export, but more core is India's domestic demand
for generic drugs.
Similarly, although the current domestic pricing factors determine the ceiling of the pharmaceutical industry, it needs to obtain a payment environment that matches the original innovative drugs of the United States, so it has to extend its registration and commercialization tentacles overseas
.
But China itself obviously has this huge unmet
medical and health need.
medical and health need.
On the one hand, the rising rate of aging population, on the other hand, the increasing life expectancy, under the superposition of two factors, a large number of clinical needs need to be met
urgently.
A clear example is that the penetration rate of a large number of diseases in China and the five-year survival rate of cancer are at a low level, and the treatment rates of diabetes and hypertension in China are 33.
4% and 41.
1%
respectively.
This means that more than half of people with chronic diseases either fall ill without knowing it or still do not have access to effective treatment
.
Either way, developing severe disease is a big blow
for individuals and families.
Not long ago, the Central Committee of the Communist Party of China and the State Council issued the Outline of the Strategic Plan for Expanding Domestic Demand (2022-2035), and health demand is the most basic need, and it is naturally an important link
in this planning outline.
This means that even if there is no blessing of "going to sea", the entire domestic medical market still has a lot of room for expansion, and the suppression brought about by the previous price reduction policy is only temporary after all
.
Demand and supply complement each other, and without a large amount of supply, demand is only rice cooking
.
This also reflects a proposition that has been being raised in the past two years, that is, supply chain autonomy
.
.
The rise of pharmaceutical upstream manufacturing is a necessary way
for the domestic pharmaceutical industry.
Because the benign development of an industry relies on close cooperation and synchronous progress from top to bottom, China cannot compete with the increasingly mature pharmaceutical industry in Europe and the United States only by relying on a large number of patients and cheap bio/medical labor
.
The development of domestic supply chain, high-end and autonomy have also been written into the "14th Five-Year Plan" pharmaceutical plan
.
In the past two years, when the price of drugs was greatly bargained, many people in the industry felt that pharmaceutical products seemed to be about to return to the attributes of public goods: as if this kind of product linked to people's livelihood, profit is a natural original sin
.
But health is both a right and a responsibility
in any people.
Some people are squandering their health, while others have dedicated their entire lives to the industry
.
Life is priceless, but clinical value can be quantified, and in the terminal stage of tumors, "living" and "living with dignity and quality" are completely different things
.
Moreover, the biomedical industry is a highly scientific, rigorous and long-term industry
.
In China, the automotive industry has given birth to trillion-dollar companies, the mobile phone industry has given birth to trillion-dollar companies, and even there are "monsters" like Moutai in the liquor field
.
The field of biomedicine, which is committed to a better way of human survival, will eventually usher in its own king
.
