From license out to mutual shareholding, this pharmaceutical company quickly established an overseas presence!

On June 30, Ailis Pharmaceuticals announced that it has authorized its third-generation EGFR-TKI overseas market development and commercialization rights to ArriVent, the United States.

This transaction has made Allis Pharmaceuticals, accustomed to low-key, “a blockbuster”.

"Going out and bringing in requires a basis and a team to help us do it", Du Jinhao, the founder of Iris Pharmaceuticals, explained the real reasons behind the transaction to the "Pharmaceutical Industry"·E Pharmaceutical Manager.

This is a microcosm of Chinese innovative drugs going overseas

On the one hand, this is due to the policy environment

Taking PD-1 as an example, the PD-1 products of four local pharmaceutical companies have entered medical insurance through price reductions.

On the other hand, going overseas to sell Chinese medicines to the international market is a historical mission that China's pharmaceutical industry has been looking forward to accomplishing since the beginning of the trading of raw materials

As for how to achieve the goal of going overseas, companies with different resource endowments adopt different methods, but whether it is license-out or independent international multi-center clinical application and listing, the core of this is the differentiated competitiveness of products

01 License-out in Evolution

Tang Yanmin, an investment partner of Qiming Venture Capital, recalled that the company she was first exposed to looking for innovative drugs in China and hoped to introduce them to overseas markets was Huya

Microchip Biologics can be regarded as a pioneer in license-out.

After 2015, China joined the ICH, and the regulatory system and standards are gradually in line with international standards.

Leveraging is the main appeal of the License-out project

In 2021, the cooperation between Iris and ArriVent has explored new possibilities for innovative drugs to go overseas

Before signing the cooperation, we have received multiple letters of intent, many of which are multinational pharmaceutical companies

However, while the external authorization of local innovative drugs continues to set new records, it must also be admitted that there is still a considerable gap in China's pharmaceutical innovation compared with the global one

02 Internationalization requires real innovation

Innovation is the foundation and internationalization is the result.

Homogenization is a word often mentioned in the industry to describe the current state of pharmaceutical innovation
.
To go abroad to gain recognition, the "window paper" of homogenization must be punctured
.

In recent years, more and more local pharmaceutical companies have participated in the American Society of Clinical Oncology (ASCO), trying to show the innovation of their products, but the reality is always "pouring cold water
.
" At the ASCO meeting in 2021, the varieties presented by domestic pharmaceutical companies basically cover the TOP10 mainstream tumor types, whether it is ORR (Objective Response Rate) or PFS/OS (Median/Overall Survival).
Place
.
But some market observers bluntly said: These ASCO's local Chinese anti-tumor drugs, there is not a differentiated one
.

In addition to homogenization, what is more serious is the impetuous mentality of the entire industry
.
As we all know, the gold standard for measuring whether a drug is best-in-class is a head-to-head test
.
For head-to-head trials, most people’s first reaction is high risk and high investment.
The subtext behind it is that the drugs themselves are not good enough.
Those who take the initiative to do head-to-head trials are praised as "braves
.
"

Another embarrassing phenomenon is that pharmaceutical companies can clearly see serious "involution" but cannot stop
.
A PD-1 pharmaceutical company once confessed to the "Pharmaceutical Industry"·E drug manager, "It has invested too much and can't stop it
.
"

Homogenization is the restriction factor of the medicine itself, and the unfamiliarity of the overseas market rules by Chinese pharmaceutical companies further deepens the influence of the restriction factor
.

Some pharmaceutical companies have carried out clinical trials overseas.
After more than a decade, the results are still pending
.
Over time, this has presented a kind of "false appearance" to the industry: the U.
S.
Drug Administration (FDA) treats China's clinical data differently
.

This is not the case
.
He Ruyi told the "Pharmaceutical Industry·E Drug Manager" that in the FDA, there is actually no strict sense of whether the data comes from the United States or outside the United States, because most of the clinical trial data accepted by the FDA comes from outside the United States, so the FDA standards As long as the clinical trial data submitted by the company meets the requirements, it can support the application no matter where the clinical trial is completed
.

03 Commercialization problems

It is the ultimate goal of internationalization to sell drugs developed and produced by Chinese pharmaceutical companies in foreign markets
.

At present, the international multi-center clinics carried out by Chinese pharmaceutical companies have achieved tremendous progress in numbers
.
According to the latest data from CDE, as of July 19, the number of international multi-center trials registered in China has reached 1,126, accounting for approximately 8.
31% of all clinical trials
.
Among them, the Chinese pharmaceutical company that has carried out the most clinical trials overseas and has the most extensive layout is BeiGene, with clinical projects all over the world
.
Take Zebutinib as an example.
The product has been approved in the United States, China, Canada, UAE, Israel and other countries or regions, and many more are in the approval process
.

Thanks to its early overseas clinical deployment, BeiGene is facing the commercialization process earlier than other innovative pharmaceutical companies
.
Unlike other products that "borrow a ship to go to sea", Zebutinib's overseas development and commercialization rights are all completed by itself
.
At present, Zebutinib has submitted more than 20 related listing applications worldwide, and its footprint has covered more than 40 countries and regions in Asia, North America, South America, Europe and Oceania, including many "Belt and Road" countries
.
In terms of overseas commercialization, Wu Xiaobin also revealed that BeiGene already has a hematological tumor layout in the United States, and a commercialization team is operating
.
According to the latest prospectus, Baekje's global commercialization team has more than 1,800 people
.

Different from the domestic market, in the international market, first-mover advantage has a huge impact on the market structure of innovative drugs after the launch
.
Zebutinib is the third BTK inhibitor in the world.
In 2020, the global sales of Zebutinib will reach 41.
7 million US dollars, or about 269 million yuan
.
The world's first BTK inhibitor ibrutinib has global sales of 9.
442 billion U.
S.
dollars in 2020, accounting for almost 95% of the total share of the BTK market
.
This result is in line with the laws of the international market: the world's first listed drug has a market share of 64%, the world's second listed drug has a market share of 25%, the third is close to 10%, and the fourth and fifth place.
Products outside the world account for a very small proportion of the global market
.

This is related to the product itself, and of course it is also related to the rules of commercialization of products in the international market
.
Take the United States as an example.
The sales of innovative drugs mainly rely on the commercial insurance system.
“The number of commercial insurance companies in the United States may reach thousands, and the competition among them is extremely fierce, and it is not possible to take an absolute advantage when entering insurance
.
A drug has entered 100 commercial insurance companies, but one is not covered by commercial insurance, so consumers will not buy insurance from this company
.
So how to understand and integrate into the US commercial insurance system, and enter into commercial insurance through price negotiation The list is very important
.
" Wang Yinxiang said
.

In fact, the connotation of internationalization not only includes the spillover of China's pharmaceutical innovation, but also includes the absorption, digestion and integration of overseas influential innovations into its own system
.
Take Qilu as an example.
This large traditional Chinese pharmaceutical company is absorbing more overseas innovative projects in three ways
.
Qilu Pharmaceutical CBO and CIO Ni Binhui summarized them into two chains: the first chain keyword is cooperation.
R&D centers are established in Boston, Seattle, San Francisco, and Shanghai, BD teams are set up, and all global innovations are integrated through product cooperation and authorization.
Directly converge to the group; the key word of the second chain is investment.
Through the close integration of investment layout and BD, innovation is widely integrated into the group.
Currently, Qilu Pharmaceutical has contacted several funds, and the number will increase by the end of this year.
"Use their resources It further opened up the communication channel between global innovation and Qilu Pharmaceutical
.
"

The way is to serve the goal.
The overseas strategy of each pharmaceutical company will be different according to the comprehensive factors such as the stage of the company and the stage of the product.
How to achieve a relative balance between input and output, innovation and success, and the early clinical stage Product development rights or technology platform License-out is also a good choice for the development of innovative drug companies and the industry
.
At present, most Chinese innovative pharmaceutical companies have not yet begun to make profits, but with the increasing number of innovative drugs in China, the overflow of innovative value is an inevitable trend
.
China's innovative drugs start from licensing and multi-center clinical development, and will gradually expand to production and commercialization
.