【Big Data Perspective】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.

1.

Figure 1 shows the changes in the number of innovative biological drugs declared from 2015 to the first half of 2021.

Figure 1 Changes in the number of innovative biopharmaceutical applications

Figure 2 shows the distribution of innovative biopharmaceutical treatment fields declared in 2016-2020

Figure 2 Distribution of innovative biological drug treatment fields declared in 2016-2020 (according to generic names)

Approval pattern of innovative biopharmaceuticals in China

Figure 3 shows the changes in the number of generic names of innovative biopharmaceuticals approved by China and the United States

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.

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

Figure 4 shows the distribution of innovative biopharmaceuticals approved in China from 2016 to 2020

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

Next, we further analyze the technical classification of innovative biological drugs approved in the past five years

Figure 5 shows the distribution of technology categories of innovative biological drugs approved in the past five years

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)

2.

Figure 7 shows the proportion of approved generic names for domestic innovative biologic drugs

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 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"

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 Biology 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 CStone Pharmaceuticals to exclusively authorize EQRx to develop and commercialize suglizumab (PD-L1) and CS1003 outside of China.
(PD-1) These two drugs
.

Figure 8 Clinical progress of JAB-3068 and JS004

3.
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
.
As can be seen from the figure, the market size 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
.

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 that there are a total of 4 blockbuster products with sales of more than 1 billion
.
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
.

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
.