How will innovative drugs go in 2022?

In 2021, the pharmaceutical industry will be affected to a certain extent due to the promotion of policies such as centralized procurement, consistency evaluation, and a new round of medical insurance negotiations, and internal differentiation will further intensify
.
But the pharmaceutical industry is an industry with long-term steady growth
.
Looking forward to 2022, the industry believes that with the increasing domestic aging, increased investment in medicine and health, continued improvement in health consumption, and the development of emerging industries such as Internet healthcare, the development prospects of the pharmaceutical industry in 2022 are still worth looking forward to
.
How will innovative drugs go in 2022? (Image source: Pharmaceutical Network) Among them, the field of innovative drugs has attracted much attention from the industry.
At present, China's innovative drugs are already in a period of vigorous growth
.
Data predict that by 2025, China's innovative drug market will reach 760 billion yuan, and the compound growth rate from 2019 to 2025 will be as high as 32.
12%
.
From the perspective of industrial development trends, with the introduction of centralized procurement policies and intensified market competition, the industry generally believes that marketization and internationalization are the general direction of the development of the innovative drug industry
.
Since the beginning of this year, the relevant policies of the pharmaceutical industry have been promulgated continuously, and the main direction is to encourage innovation and upgrading, especially in July this year, CDE issued the "Clinical Value-Oriented Clinical Research and Development Guidelines for Antitumor Drugs" to further encourage differentiated innovation
.
Under this policy, the market expects that ME-too R&D with "pseudo-innovation" as the mainstay will accelerate out of the market, and the market share of capable pharmaceutical companies is expected to further increase
.
The industry pointed out that with the rise of local innovation forces, the wave of domestic substitution and internationalization is coming
.
At present, more and more local pharmaceutical companies are no longer confined to the domestic market, but are actively participating in global market competition in accordance with international standards by increasing R&D investment, and stepping out of the road to internationalization
.
For example, BeiGene has already sounded the clarion call to set sail.
In November 2019, BeiGene's self-developed BTK inhibitor Zebutinib opened the territory of overseas approval for listing, and has now achieved its presence in 40 countries around the world.
Approved for listing, and submitted more than 20 listing applications in other countries and regions around the world
.
The financial report for the third quarter of this year showed that the global sales of Zebutinib had reached 65.
8 million U.
S.
dollars, an increase of 320% compared with the same period last year.
Domestic sales also performed well, achieving an increase of 223% compared with the same period last year
.
Since BeiGene’s Zebutinib went overseas, more and more local pharmaceutical companies, including Hengrui Pharmaceuticals, Sino Biopharmaceuticals, Biotech, Henlius, Cinda Biotech, etc.
, have increased their R&D investment, allowing Products are gradually becoming international, and more and more pharmaceutical companies are recognized by international pharmaceutical giants
.
Among them, overseas licensing (license out) is a common method.
In this way, local pharmaceutical companies can obtain a certain amount of cash flow and quickly realize the commercialization of their own products
.
Statistics show that since 2021, there have been over 13 overseas authorized projects
.
At present, the development of domestic innovative drug projects is gradually changing from being introduced (license in) to going out (license out)
.
Under the new model, on the one hand, it demonstrates the strength of local innovative drug companies, and on the other hand, it is also conducive to accelerating domestic innovative drugs to the international stage.
Welcome, it is expected that more domestically-made innovative drugs will enter the overseas market in 2022.

” For some fiercely competitive tracks, the international layout is also a new channel for companies to ease the pressure of competition and seek new growth points
.
Take PD-1 products as an example.
At present, the four major domestic PD-1 products have been included in medical insurance, and two new products have been launched this year, and there are still a bunch of products waiting to be listed
.
With the promotion of centralized procurement and medical insurance negotiations, the price reduction of PD-1 products is a trend, and the pressure on related companies will double
.
In order to seek new growth points and enhance competitiveness, domestic PD-1 companies are also accelerating their pace of internationalization in addition to deploying new indications
.
For example, in February 2021, Junshi Biotech and Coherus reached a cooperation on the development and commercialization of Tereprizumab in the United States and Canada, and Coherus was responsible for all commercial activities in the United States and Canada.

.
In March 2021, Junshi Biologics announced that it had submitted a rolling submission to the FDA for a biological product license application for teriprizumab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)
.
On September 1, the company stated that it had completed a rolling submission to the US FDA regarding teriprizumab combined with gemcitabine/cisplatin as the first-line treatment and single agent for recurrent or metastatic nasopharyngeal cancer patients.
BLA for second-line and above treatment after platinum-containing chemotherapy
.
According to the company's plan, it will actively promote the commercialization of tereprizumab in China, the United States and other countries to benefit more patients with nasopharyngeal cancer
.
Some analysts said that the innovative drug companies that can break through the siege in the future are companies that independently take the road of difficult differentiation, and the other is the path of integrated pharmaceutical companies that place equal emphasis on domestic and overseas, and balance technology and business
.
Regardless of which path is taken, the test will be the research and development capabilities of pharmaceutical companies
.