It was revealed that the biggest winner in the domestic Class 1 new drug market was actually it!

Since the NMPA released a new version of the chemical drug registration classification scheme in 2016, which defines "new drugs" as "global new", the number of domestically produced Class 1 new drugs has increased by leaps and bounds

Is there really a large enough market for these local Class 1 new drugs approved after 2016? Are there any "blockbuster" best-selling products? Will medical insurance negotiations help the growth of the local innovative drug market? With these questions, answer them one by one based on the unique Chinese pharmaceutical sales (magnified) of the China Pharmaceutical Industry Information Center

What is the overall market for the domestic Class 1 new drugs approved after 2016?

Before giving the answer, let us clarify the statistical rules

The first domestic category 1 new drug approved in 2016-2020, and the category 1 new drug developed by MNC companies has been removed from the research and development of local companies (such as Pfizer’s dacomitinib, Novartis’ sinimod, and Fabojin’s rosax He) removed Class 1 new drugs that had been approved for products with the same generic name before approval (such as the enterovirus 71 inactivated vaccine of Wuhan Institute of Biological Products, Xiamen Tebao's peginterferon α-2b injection liquid)

Table 1.

Figure 1 shows the changes in the overall market size of the 25 products participating in the statistics in China

Figure 1.

This growth is not only due to the increase in the number of local innovative products, but also to the excellent quality and efficacy of these innovative products

What are the "blockbuster" of the local Class 1 new drugs approved after 2016?

Figure 2 shows the overall market sales of 25 local Class 1 new drugs approved for the first time in 2016-2020 in China in 2020

The 4 products framed in the red box are "blockbusters" with sales exceeding 1 billion, including Hengrui's Carrelizumab, Chia Tai Tianqing's Anlotinib, and Cinda's Sintilizumab.

Among these 8 products with sales of more than 100 million, carrelizumab targeting PD-1 is undoubtedly the biggest winner, with sales of up to 5 billion! The other 3 approved PD-1 monoclonal antibodies are also among them, so #PD-1 What is the future? You can see at a glance

There are also three products with sales of more than 50 million, including Hausen’s flumatinib and ametinib, and Green Valley’s Ganlutner, which may be among the best-selling products with sales of more than 100 million in 2021

Figure 2.

After the domestic Class 1 new drugs are included in the medical insurance negotiations, can they "trade price for quantity"?

Figure 3 shows the changes in sales and sales volume of Anlotinib in China's overall market included in the medical insurance negotiations in 2018

Figure 3.

Figures 4-8 respectively show the changes in the overall sales and sales of the five products included in the medical insurance negotiations in 2019.

Through the above analysis, it can be found that the inclusion of domestic Class 1 new drugs in the medical insurance negotiations can indeed "replace price for volume", and the sales volume has risen significantly, and the effect of "high volume pulling" is also significant.

Table 2.
Sales volume and sales growth rate of products included in medical insurance negotiations in 2019

Figure 4.
Sales and sales changes of nanofloxacin in China's overall market

Figure 5.
China's overall market sales and changes in sales of recombinant cytokine gene-derived proteins

Figure 6.
The overall sales and sales volume changes of pyrrotinib in China

Figure 7.
Sales and sales volume changes of furquintinib in China's overall market

Figure 8.
The overall sales and sales volume changes of Sindili Mab in China