The wave of innovative drugs is approaching, who can take the lead in the internationalization of the sea of ​​stars?

Domestic PD-1 is still in a relatively early stage.
In the future, domestic PD-1 sales are expected to exceed 30 billion yuan
.

With the support of many innovative drug research projects, it is expected to maintain the trend of 10 innovative drugs on the market every year in the future
.

Assuming that the proportion of domestic innovative drugs in the pharmaceutical industry will increase from about 8% to 30% by 2025, the market increment space for the entire innovative drug industry will exceed 600 billion yuan
.

01Four -fold driving force to promote the vigorous development of innovative drugs

01Four -fold driving force to promote the vigorous development of innovative drugs

In his sharing, Liu Zexu pointed out that the current situation has played an important role in promoting the vigorous development of innovative drugs in terms of demand, policies, human resources and capital
.

From the demand side, the domestic demand for innovative drugs is very strong
.

The overall 5-year survival rate of cancer patients in China is 40.

Liu Zexu said that the needs of patients have always been there, but the release of demand is inseparable from the development of the economy and the improvement of the ability of patients to pay
.

In the past two years, the state has introduced many policies to support the development of the innovative drug industry
.

Since 2015, the State Food and Drug Administration has issued many policies to optimize review and approval, such as the priority approval system for innovative drugs, and green channels such as breakthrough therapies that have been newly launched in the past two years

Previously, many innovative products were relatively slow in volume and expensive.
Especially before the introduction of the national medical insurance negotiation system, the annual cost of using innovative drugs may reach more than 100,000 to 200,000 yuan a year, and there is no reimbursement
.

Since 2016, the implementation of the national medical insurance negotiation and the normalization of the national centralized procurement have won more favorable prices for patients

According to the data analysis of NMPA and the National Medical Insurance Administration, the average time difference between the launch of new drugs and their inclusion in the National Medical Insurance Catalog from 2017 to 2020 was 8.
7, 5.
3, 4.
5, and 1.
8 years, respectively, and the time difference gradually shortened.
The time is up to August 17 of that year, giving a faster access time for newly approved new drugs
.

"I believe that in the future, new products will be launched in the same year and included in medical insurance in the same year, which will become the future development trend," said Liu Zexu

In addition, innovative drugs are a typical technology-driven industry, and we are delighted to see that there are more and more R&D talents for innovative drugs
.

With the popularization of higher education in China, these engineer dividends have spawned many of the world's top CRO companies, and these CRO companies have also fed back and empowered domestic innovative pharmaceutical companies

From the perspective of the capital market, among the financing in the primary market, the pharmaceutical industry has become one of the hottest investment sectors
.

The shareholder structure of many innovative drug companies is supported by top investment institutions

02The launch of innovative drugs is about to enter the blowout period

02The launch of innovative drugs is about to enter the blowout period

Driven by many favorable factors in China, the domestically approved innovative drugs have shown explosive growth
.

In terms of the number of innovative drugs on the market, the number of innovative drugs approved by China's Drug Evaluation Center has increased year by year in recent years.

From the perspective of the number of domestic innovative drug clinical trials, the number of domestic innovative drug clinical projects increased significantly from 2015 to 2019, from 198 in 2015 to 887 in 2019, of which 234 were increased in 2019 compared with 2018, a year-on-year increase of 35.
8% , still maintaining a rapid growth trend
.

The clinical development of innovative drugs takes about 4 to 5 years as a cycle.

Sales figures for innovative drugs are also encouraging
.
Taking PD-1 as an example, in just two years, the PD-1 market has achieved sales revenue of more than 10 billion yuan from zero
.
This also proves once again that if the product really meets the unmet clinical needs, its market prospects are still promising
.
Liu Zexu said that domestic PD-1 is still in a relatively early stage, and domestic PD-1 sales are expected to exceed 30 billion yuan in the future
.

In addition, there are also many cases that prove that after the product enters the medical insurance catalog, the effect of heavy volume is obvious
.
From 2016 to 2020, the decline in medical insurance negotiation was 58.
6%, 44%, 56.
7%, and 50.
6% respectively
.
Taking pyrotinib and thiopefilgrastim as examples, the sales of sample hospitals in 2019Q1-Q3 were 20 million and 17 million, respectively.
After the medical insurance negotiation entered the medical insurance in 2019, the sales of sample hospitals in 2020Q1-Q3 were 151 million and 17 million respectively.
266 million yuan
.

After nearly three years of rapid development, the current proportion of the innovative drug industry in China's pharmaceutical industry is only about 10%
.
In contrast, in the US market, its innovative drug industry accounts for about 70% to 80% of the sales of the pharmaceutical industry
.
From this perspective, the domestic innovative drug industry still has a lot of room for development
.

In addition, in terms of the development stage of the industry, Liu Zexu said that the domestic innovation in the past two years has undergone a deeper transformation, and the entire innovation level is transitioning from the low-level innovation in the past to the high-level innovation
.
At present, some innovative drug faucets have shown the potential of me better or even best-in-class
.
From the perspective of product efficacy, for example, Junshi's PD-1 monoclonal antibody has a very high ORR in urothelial carcinoma
.
This also proves from the other hand that domestic innovative pharmaceutical companies have developed to the stage where they can directly PK with import companies
.

In his sharing, Liu Zexu said that if the proportion of domestic innovative drugs in the pharmaceutical industry increases from 8% to 30% by 2025, the market increment space for the entire innovative drug industry will exceed 600 billion yuan in the future
.

03The first year of internationalization of innovative drugs is approaching

03The first year of internationalization of innovative drugs is approaching

To measure how strong a domestic enterprise is in terms of innovation, it also depends on whether the enterprise has global competitiveness
.

Objectively, the most developed regions in the world's innovative drug industry are still in Europe and the United States.
The entire drug market share in these regions is dominated by innovative drugs, and the competition for innovative drugs is very fierce
.

If an innovative drug is still competitive in the European and American markets, there is no doubt about the company's innovation capability
.
In the past few years, many domestic innovative drug companies have gradually entered the global market from the Chinese market, such as BeiGene, GenScript, and Hutchison
.
"We believe that by 2022, more and more innovative drugs will be launched overseas, and 2022 may be the first year of internationalization of domestic innovative drugs," shared Liu Zexu
.

In addition to the overseas listing of new products, the standard that can reflect the company's global competitiveness is that the company's innovative drug products can be certified by foreign regulatory authorities, such as breakthrough therapies, including orphan drugs, fast-track review channels,
etc.
Among them, the highest gold content certification is the FDA's breakthrough therapy certification
.
This means that the clinical design of the product itself is very standardized, the clinical effect is very good, or the quality of the early molecular design technology is very good
.

Liu Zexu pointed out that whether a company can successfully license its products to overseas big pharmaceutical companies through BD is also an important manifestation of the company's global competitiveness
.

At present, it is quite difficult for Chinese innovative pharmaceutical companies to carry out sales and commercialization overseas alone
.
However, if the product is authorized to overseas big pharmaceutical companies with mature channels, it can be regarded as a feasible path
.
Liu Zexu's analysis believes that under normal circumstances, international giants have very strict audits on their partners.
They will conduct comprehensive investigations on the company's compliance, internationalization capabilities, product efficacy, etc.
If the Chinese company passes the assessment, the two parties will achieve cooperation and The amount is huge, so it is enough to prove the competitiveness of this product and this company
.