After local pharmaceutical companies laid off their U.S. R&D teams, he is considering returning to MNC or returning to China. The internationalization of innovative drugs is still "paying tuition"...

The difference in supervision is undoubtedly a major "roadblock"
for China's innovative drugs to go global.
Previously, when BeiGene and Legend Biologics' products were approved by the FDA and frequently successfully "went overseas", many people "smelled" the FDA's "tolerance" for Chinese innovative drugs
.

For a time, the relatively lucrative US market has become a hot land
for innovative drugs to "go to sea".
However, some analysts pointed out that since the end of last year, the FDA seems to have reversed the wind, causing many companies to withdraw their product applications
.

However, there are also different views that there is no such thing as a "change in the direction of the wind," and the failure to "break through" did not begin
last year.
"Chinese innovative drugs pay a lot of tuition fees on the way to sea, but I always feel that the lessons learned are still not enough
.
"

An industry insider who works in a U.
S.
pharmaceutical company and has been paying attention to the Chinese market for a long time pointed out, "In my opinion, there are two extremes
at present.
First, some people think that the FDA is too 'tolerant', such as taking a clinical study of a conditionally approved product to submit, which is easy to be rejected; second, some people think the FDA is too 'mysterious', worried about cultural differences, Sino-US games and a series of external factors, which play a great negative role in it, and are afraid
of it.
In fact, it is not so complicated at all, the FDA is to look at the data and products, as long as the data is good and true, and the product advantages are obvious, there must be opportunities
.
”

In terms of specific operations, how to knock on the FDA door? The first step, of course, is to fully understand the policy
.
In a previous interview, Liu Que, CMO of Yachuang, pointed out to E drug managers that the understanding of the FDA's regulatory philosophy and rules may be the first barrier
for local pharmaceutical companies to open up the US market.
In his opinion, the FDA's information disclosure is very transparent, in addition to information access, the heads of various FDA departments will have regular lectures, which is very valuable
for Chinese companies.
Other than that, the best way is to engage
with them.

FDA is a service-oriented department, and if a company wants to prepare for an IND, the company can make an appointment with the FDA for a pre-IND meeting
.
"In this link, the most important thing is to communicate early and listen to their opinions, especially in clinical design and implementation, to consider what kind of data to produce, what kind of patients to enroll, from which regions to call patients, etc.
, these issues need to communicate with regulatory agencies to start registration for clinical trials, so the success rate will be higher
.
" The head of BD of an innovative pharmaceutical company pointed out
.

Some Chinese in the pharmaceutical industry working in the United States suggest to domestic pharmaceutical companies that it is best to recruit some local experienced employees as "guides"
.
"The priorities of many things are not intuitively expressed on documents
.
" She believes that finding a good "guide" can save a lot of exploration
, trial and error, and paying tuition.
In terms of channels, you can contact through relatively large headhunting companies, through some local medical circles, etc.
, or simply through some personal relationships
.

But there is one thing to note, that is, the company's management philosophy, management model, and respect
for employees.
Only a good company can really attract excellent people to join
.
Pharmaceutical companies "go abroad" to build teams, which are generally divided into three categories, recruiting locals, recruiting local Chinese, and sending company executives to expand the market
.
Except for the third category, which does not have cultural identity, the remaining two types of retention under cultural identity after recruitment have always been a challenge
that Chinese pharmaceutical companies need to overcome when building overseas teams.

Ideally, "double-faced" talents who are familiar with the local market and have rich practical experience in overseas markets are important
.
These are more clear about clinical practice, domestic and foreign regulations, etc.
, which is more conducive to pharmaceutical companies to do better globalization, and teams can establish full "interaction"
.
"If Chinese pharmaceutical companies want to successfully go overseas to the United States, from the beginning, they must make clearer plans
in terms of strategic settings based on their own development strategies, investment stages and strength scale.
"

The above-mentioned Chinese in the pharmaceutical industry who started a business in the United States believe that "entering the local market requires extreme localization, and local managers with all-round careers and experience are also needed to operate, but it is difficult for companies to find and retain suitable long-term talents
.
" Chinese enterprises going abroad, after formulating a clear strategy, must match the corresponding funds and talents, complete the construction of the talent echelon, and finally focus on overcoming difficulties, but this is not an easy task
.
”

In the end, it is product competitiveness