The innovation pattern of China's biopharmaceuticals

Biomedicine is a strategic industry that is prioritized by countries all over the world in the 21st century.
The biomedicine industry with "innovation" as its core is developing more and more prosperous and continues to burst with fresh vitality
.
Today, we use big data to deeply analyze the R&D, approval and market structure of China's biopharmaceutical innovation

.

The review and approval of innovative biopharmaceuticals has greatly improved the R&D landscape of innovative biopharmaceuticals in China in terms of quantity and quality.

The review and approval of innovative biopharmaceuticals has greatly improved the R&D landscape of innovative biopharmaceuticals in China in terms of quantity and quality.

Figure 1 shows the changes in the number of innovative biological drugs declared from 2015 to the first half of 2021.
Innovative biological drugs are defined as products declared as category 1 biological products for therapeutic or preventive use
.
It can be clearly seen from the figure that whether it is to calculate the number of acceptance numbers or the number of common names, the number of applications in 2020 has a significant leap .

The number of common names has increased by 140%, and the number of accepted numbers has increased even more.

There is a big leap in the number of applications in 2020.

Figure 1 Changes in the number of innovative biopharmaceutical applications

Figure 2 shows the distribution of innovative biopharmaceutical treatment fields declared in 2016-2020
.
As most people expected, anti-tumor drugs accounted for the largest proportion, almost half of the number of generic names declared

.

Anti-tumor drugs accounted for the largest proportion, almost half of the total number of generic names declared

Figure 2 Distribution of innovative biological drug treatment fields declared in 2016-2020 (calculated by generic name)

Approval pattern of innovative biopharmaceuticals in China

Approval pattern of innovative biopharmaceuticals in China

Figure 3 shows the changes in the number of generic names of innovative biological drugs approved in China and the United States
.
FDA-approved innovative biological drugs are defined as BLA applications approved for the first time through the 351(a) route; NMPA is defined as imported original research approved for the first time by a generic name, and those declared as category 1 biological products for therapeutic or preventive use during review Merchandise

.

As can be seen from the figure, from 2016 to 2018, the number of approved innovative biologics in China has increased significantly, starting to approach the United States in 2018, and the number of approved biopharmaceuticals has surpassed that of the United States since 2019.
Both the number of approved biopharmaceuticals in 19 and 20 years A few more than in the United States .

Since 2019 , the number of approvals surpasses the U.
S.

Figure 3 Changes in the number of generic names of innovative biopharmaceuticals approved by China/U.
S.

Figure 4 shows the distribution of innovative biopharmaceuticals approved in China from 2016 to 2020
.
Similar to the declaration, the largest proportion of approved drugs is still anti-tumor drugs, reaching 30%

.

The largest proportion of approved drugs is still anti-tumor drugs, reaching 30%

Figure 4 The distribution of innovative biological drug treatment fields approved by China from 2016 to 2020 (calculated by generic name)

Next, we further analyze the technical classification of innovative biological drugs approved in the past five years
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Figure 5 shows the distribution of technology categories of innovative biological drugs approved in the past five years
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It can be found that antibody drugs are the approved mainstream technology category, accounting for 61% of the approved generic names

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Antibody drugs are the approved mainstream technology category, accounting for 61% of the approved generic names.

Figure 5 The distribution of innovative biopharmaceutical technologies approved by China in 2016-2020 (by generic name)

Figure 6 The distribution of innovative biological drug targets approved in China from 2016 to 2020 (calculated by generic name)

The research and development of domestic innovative biological drugs is gradually diversified

The research and development of domestic innovative biological drugs is gradually diversified

The analysis in the first part above includes all innovative biologics approved in China, some of which are imported products developed by MNC in China
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What about the performance of our local domestically-made innovative biologic drugs when R&D is approved?

Figure 7 shows the proportion of approved generic names for domestic innovative biologic drugs
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It can be seen that the proportion of domestic generic names approved in recent years has been relatively stable, at about 20% .

The proportion of domestic generic names approved in recent years has been relatively stable, at about 20%

Figure 7 Proportion of approved generic names of domestic/imported innovative biological drugs

Although the proportion of domestic products has not seen a significant increase, the richness has been greatly improved
.
Table 1 lists the domestic innovative biological drugs approved from 2016 to the present

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It can be seen that the products approved before 2021, except for vaccines, are basically PD1 monoclonal antibodies, and the treatment categories and application technologies are relatively monotonous
.
Starting from 2021, the approved products have become "various".
In addition to monoclonal antibodies, there are also antibody-conjugated drugs (ADC) and CAR-T drugs; the targeted targets are not only PD1, but also involve tumor necrosis factor, HER2, CD19 and the like
.
This shows that the technologies and targets involved in the approved domestic innovative biopharmaceuticals have gradually diversified , and the previously declared accumulations have begun to bear fruit
.

The technologies and targets involved in the approved domestic innovative biological drugs have gradually diversified

Table 1 List of domestic innovative biological drugs approved from 2016 to date

In addition to richer products, the research and development strategy of domestically-made bio-innovative drugs has also begun to change from "following" to "leading"
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Previously, most local biopharmaceutical R&D companies paid more attention to the development of biosimilars, but recently, more and more local companies have begun the development of pioneering drugs
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PharmaONE, a smart drug big data analysis platform, has monitored (see Figure 8) that JAB-3068, the world’s first SHP2 inhibitor developed by Jacos, has carried out Phase II clinical trials for a variety of solid tumors; another example is the global research and development of Junshi Biotech The first specific BTLA monoclonal antibody JS004 has been carried out for phase II clinical trials for lung cancer and phase I clinical trials for head and neck cancer
.
All this shows that the research and development of domestic biopharmaceuticals is gradually transforming from bio-similar to first-in-class, challenging the global initiative mechanism
.

The research and development strategy of domestically-made bio-innovative drugs has also begun to change from "following" to "leading"

In addition, the research and development results of domestically produced bio-innovative drugs are gradually going global , and many Chinese-developed products are licensed to MNC overseas
.
For example, Cinda granted Eli Lilly Sintilizumab an exclusive license outside of China, and is committed to promoting Sintilizumab to North America, Europe and other regions; such as the CD47 independently developed by Tianjing Biological and AbbVie.
The monoclonal antibody TJC4 cooperates in the global development and commercialization, and the rights and interests outside China are licensed to AbbVie; another example is the exclusive authorization of EQRx by CStone Pharmaceuticals to develop and commercialize suglizumab (PD-L1) and CS1003 outside of China.
(PD-1) These two drugs
.

The research and development results of domestic bio-innovative drugs are gradually going global

Figure 8 Clinical progress of JAB-3068 and JS004

The market potential of domestic innovative biological drugs is huge

The market potential of domestic innovative biological drugs is huge

The second part analyzes the R&D approval performance of domestic innovative biological drugs, and then we analyze their market performance to see if they sell well in the market
.

Figure 9 shows the changes in the overall market size and growth rate of domestic innovative biologics in China from 2016 to 2020
.
The so-called "domestic production" here is the removal of new drugs developed by MNC companies, as well as new drugs that have been approved for products with the same generic name before approval; the so-called "overall market" is an enlarged data of national sales
.
It can be seen from the figure that the market scale of domestically-made innovative biological drugs has grown rapidly in the past five years .
The growth rate in 2019 is close to 100% , and the growth rate in 2020 is more than 100% , with sales reaching 11.
79 billion
.

In the past five years, the market scale of domestically produced innovative biological drugs has grown rapidly.
The growth rate in 2019 is close to 100% , and the growth rate in 2020 is more than 100% , with sales reaching 11.
79 billion.

Figure 9 2016-2020 China's overall domestic innovative biopharmaceutical market size and growth rate changes

Figure 10 counts the sales of each innovative biological drug in 2020, and sorts them in order of sales
.
It can be found sales of more than 10 million blockbuster products, a total of 4 models
.
3 of these 4 products are PD1 monoclonal antibodies, including karelizumab, sintilizumab and tislelizumab.
The sales of karelizumab reach 5.
1 billion.
At the top of the sales of innovative drugs
.

Sales of more than 10 million blockbuster products, a total of 4 models

Figure 10 China's overall market for domestic innovative biological drugs in 2020 (100 million yuan)

Summarizing the analysis of the above three parts, we can see that in recent years, the number and quality of innovative biopharmaceuticals approved in China have greatly increased
.
Among them, the market potential of domestically-made innovative biological drugs is particularly huge.
The approved products include ADC, CAR-T and other technologically innovative products, and the targets involved are gradually diversifying
.
We can expect that in the future, there will be more and more first-of-its-kind domestically produced bio-innovative drugs that will not only benefit Chinese patients, but also help more global patients
.