Will Biotech be phased out on a large scale in 2022?

Will Biotech be phased out on a large scale in 2022? To what extent will internationalization be delayed? How many volumes will there be in the future innovative drugs? What are the new technologies in the era of innovative drugs 3.

On February 21, 2022, at the New Year's Outlook Conference of China's Pharmaceutical Industry hosted by E-pharmaceutical managers, Hu Qicong, Managing Director of Boston Consulting Group (BCG), and Liao Lei, founder of the medical media Archimedes Biotech, published the ecological evolution of innovative drugs and technical presentations

01

Will Biotech be phased out on a large scale in 2022?

A year ago, the industry would not have thought that a new CDE regulation on oncology would be "killed" halfway through

With a piece of New Deal, the "flooding" optimism turned into a surging "negative" sentiment.

"The market is indeed running out of liquidity

After the capital feast, it will be a mess

"A large number of Biotech factories in China have built more factories than their own needs, and they may be forced to sell factories

Despite this, Liao Lei believes that the process of de-foaming in the innovative drug industry is a long process

He explained that, first of all, from the perspective of cash reserves, the real climax of elimination may occur in two years.

Secondly, the reality of innovative drugs is not so unbearable

Hong Kong stock 18A looks relatively miserable innovative equipment companies also have no worries about survival for the time being

"Avoiding popular targets does not mean that Biotech will have nowhere to go.

02

To what extent will internationalization be delayed?

At the beginning of the new year, the FDA's review meeting on Innovent PD-1 has taught Chinese pharmaceutical companies a lesson

"Whether it is the CDE new policy or the FDA's statement on Innovent Bio, it means that head-to-head trials will become the general trend of innovative drug research and development to varying degrees

The shortcomings of the clinical trial program are actually only superficial phenomena.

In the end, it depends on the innovation and differentiation of the product

In addition, the first time domestic PD-1 broke into the FDA was frustrated, which will definitely bring some impact, and the internationalization process of innovative drugs will definitely be delayed
.
Liao Lei believes that the first shock is the substantial increase in the cost of going overseas.
The application for listing of a single data in the United States has been suspended.
The global multi-center clinical cost is huge, and only a few companies can afford it; the second shock is that the threshold for innovative drugs will be greatly increased.
, the fundamental of breaking the internationalization is to get out of Me-too/Me-better and do leading innovation; the third impact is that the road to the sea may become narrower and narrower.
Although there are many targets for innovative drugs, there is still a gap between Chinese companies.
The layout is actually pretty much the same
.

In Liao Lei's view, the fundamental reason behind the international multi-center clinical practice is actually the domestic payment and financing environment
.
"Most innovative pharmaceutical companies get financial support that is quite embarrassing
.
In order to save costs and live longer, we can only take some elimination methods, but don't be too discouraged
.
Innovative drugs are temporarily based on domestic demand, which is enough to support two or three development during the year
.
”

This year, many First-in-class or Best-in-class products of leading domestic innovative drug companies have entered a critical stage, and the probability of successful internationalization in the future will be higher, but it will take time to realize it
.

What can be seen in the future is that the internationalization pattern will change a lot
.
"Internationalization is costly, time-consuming, and has high barriers to entry.
Most small companies cannot afford it.
They have weak cash reserves and are unable to undertake the global three-phase multi-center clinical practice.
It is expected that overseas rights and interests will be transferred, which is certain
.
In addition, internationalization Hengrui Medicine, CSPC, Baiji, and Cinda in the leading camp have the ability to continue hematopoiesis, and they are more hopeful to persist to the finish line in the international long-distance running
.
”

03

How many volumes will there be in the future innovative drugs?

The term "involution" has taken the industry by storm over the past year
.
In 2022, or in the further future, will innovative drugs continue to roll out?

In Liao Lei's view, the moderate overcapacity of innovative drugs is not a problem at all, but a normal state in the future
.

There are three reasons: First, innovative drugs are the broadest track in the pharmaceutical industry, and the sales of a single product may be equivalent to the full scale of other tracks
.
Because the pool is large enough and capital floods in, duplication of pipelines and crowded tracks are inevitable, and this is also a sign of industry prosperity
.

Second, biomedicine is a decentralized innovation, without a center, and cannot be monopolized by large enterprises.
Most of the breakthrough innovations are initiated by unknown small enterprises
.
There is no surplus in production capacity planning, which will only limit the vitality of the industry.
Most Biotechs disappear before they reach the commercialization stage.
This is the normal ecology of metabolism
.

Third, I think moderate involution is something that payers are happy to see
.
The pipeline of repeated construction is abundant in supply, which reduces the price in the competition and improves the availability of innovative drugs and treatments
.

But the thing to avoid is excessive involution, say 100 PD-1s
.

How exactly do you get rid of the involution? Liao Lei believes that we can start from two directions.
One is to avoid crowding and go to the blue ocean field.
The widespread unmet clinical needs in China provide pharmaceutical companies with a sufficiently diverse living space.
There is no need to crowd out tumors, rare diseases and The field of neuroscience is also a good choice
.

Another way is to go to the forefront, such as the emergence of protein degradation therapy and molecular glue, in these fields, there is no immune target-related drug marketed globally
.

04

New technologies in the 3.
0 era

China has gradually transitioned from 1.
0 to 3.
0, and a number of pharmaceutical innovation 3.
0 products and companies have emerged
.

Hu Qicong said that in the era of 3.
0, what we see is that pharmaceutical companies have established more First-in-class in the direction of sustainable development and internationalization, and strived for innovation, and there is also a trend of launching products abroad
.
If the time axis goes back a few years, we will see the birth of more new technology platform products, and at the same time there will be more sales of new products, and the structure of the entire pharmaceutical market will undergo essential changes
.

So what are the new technologies in the 3.
0 era? How to better integrate with therapeutic areas?

In the field of rare diseases, gene therapy plays a very important role
.
In China, the start of gene therapy is not particularly early, but it is very fast in terms of speed.
A large number of research institutes have emerged, and some clinical-stage products have been established
.
At the company level, as Chinese companies go overseas, a series of gene companies, including Newfox and Faith, have emerged
.
Another feature is that there are a lot of cooperation between scientific research institutes and enterprises, such as Newfoss and Huazhong University of Science and Technology, Faith and East China University of Science and Technology and so on
.

The second block is RNA therapy, which is divided into three categories, RNAi, mRNA, and RNAa
.
Before the COVID-19 pandemic, siRNA was still very popular, and companies like Ribo and Sernaro were relatively leading companies, and their application fields focused on tumors and metabolic diseases, such as liver disease and hyperlipidemia
.
From the perspective of the mRNA field, there were not many layouts before the pandemic.
Now many companies use this technology in the development of vaccines, and some companies use it in anti-tumor and anti-infection.
There are currently no domestic products in this field
.

The third block is protein degradation technology, and a number of companies have already advanced their products to the clinical stage, such as BeiGene, Haisco, Asieris,
etc.
One feature of protein degradation technology is that it has a wide range of targets, whether it is a macromolecule or a small molecule, the prospect is very broad, so it can also be seen that many large domestic enterprises are making arrangements
.

The fourth block is PDC (polypeptide conjugate).
Now this field is not so hot, but there are also companies doing it.
Compared with ADC, PDC can solve the problem of immunogenicity and penetration caused by large molecular weight
.
Globally, there are already two products, but there are not many clinical pipelines, and many companies are considering combination therapy
.

The fifth block is the next generation of oncolytic viruses
.
In this segment, China already has a lot of research, second only to the United States in the world
.
From the product point of view, there are already 15 new candidate products in the clinical stage, almost all of which focus on the field of oncology, and the participants are mainly Biotech companies
.

The sixth block is the next generation of cell therapy, which has many branches.
The more mature ones are CAR-T products for the treatment of hematological tumors, as well as general-purpose CAR-T, CAR-NK, TCR-T, TIL, etc.
tumor transition to solid tumors, and stem cell therapy
.

The seventh is the drug delivery system, including Mirconeedle (MN, microneedle)/LNP, etc.
In the direction of MN, more than 10 Biotechs have been working in this field since 2007, but most of them are used in the field of cosmetics
.
More than 20 companies have participated in Virus&Virus-like particles (VLPs), which are mainly used in cell gene therapy and vaccines based on AAV
.

The last one is AI pharmaceuticals.
There are many references from target discovery to preclinical stage to clinical stage.
Now there are extensive layouts in the market, some focus on the front end, some focus on the back end, and some focus on the clinical stage, all of which are related to drugs.
Discovery and research have played an important role
.