Going overseas, the thorny and glory of Chinese innovative drugs

In the winter of two and a half years ago, in January 2019, the Rongchang biological team and the head of the American pharmaceutical company Seattle Genes met for the first time in San Francisco, the United States
.

Previously, Seattle Gene, the invisible overlord in the ADC (antibody-drug conjugate) drug field, showed great interest in the results of the Phase II clinical trial of the ADC drug Vidicitor independently developed by Rongchang Bio

At that time, RC48 (Rongchang's core product, and later approved vedicitumumab) had just completed phase II clinical trials
.

On the other hand, the domestic enthusiasm for innovative drugs has just been ignited by PD-1.
The entire industry has focused on biological innovative drugs.
Everyone is frantically looking at projects, buying pipelines, and pushing clinical trials
.

At that time, the voice of internationalization was not as high as it is today

Rongchang Biological also attached great importance to this meeting
.

For innovative pharmaceutical companies, the United States is simply a paradise for drug sales

Unexpectedly, just one year later, going overseas has become the most popular slogan of Chinese innovative pharmaceutical companies
.

After 2020, China’s targeted innovative drug sales market has encountered strong negotiations on medical insurance.

Rongchang Biotech's vedicitumumab (RC48) belongs to the latter.
This drug is the world's third ADC drug targeting HER2 after Genentech's Kadcyla and Daiichi Sankyo's Enhertu
.

After the two sides met for the first time, there were more than two years of negotiations
.

The other party's interest, as a result of Rongchang's ongoing clinical data, is always hot and cold

It set a new record for the highest amount of overseas authorized transactions of a single variety of Chinese innovative drugs , exceeding the US$1.
94 billion from Tianjing Bio-antitumor drug CD47 monoclonal antibody lemzoparlimab more than a year ago, and the small-molecule anti-tumor drug SHP2.
Approximately $1 billion for inhibitors
.

It has set a record for the highest number of overseas authorized transactions for a single variety of Chinese innovative drugs

This is undoubtedly good news to boost morale in this year's pessimistic atmosphere where IPOs of Chinese innovative pharmaceutical companies have been repeatedly suspended, and IPOs are worried about breaks
.

It may also mean that "relying on capital boosts, a bunch of similar innovative drugs are produced together, listed for financing, and capital makes a fortune" model of drumming and spreading flowers is gradually declining, and a "right way" for pharmaceutical companies that have the ability to go out

Behind the record high amount of authorized cooperation between the three companies is the blowout trend of cross-border license-out of domestic innovative pharmaceutical companies
.

The cross-border license-out trend of domestic innovative pharmaceutical companies
.

Since 2020 (as of August 31, 2021), the number of such transactions has reached 67, surpassing the sum of previous years and accounting for 67% of the 14 years
.

The first cross-border license-out case also occurred 14 years ago.

The cross-border license-out in 2021 is even more violent.
As of August 31, 2021, a total of 30 license-outs have occurred, which is close to the total number of last year
.

Data source: Meibo Medical and Insight database

Not only a leap in quantity, but also an inflection point where both volume and price fly together
.
For the top ten license-outs this year alone, their down payments all exceeded 100 million U.
S.
dollars.
Among them, BeiGene and Novartis reached a PD-1 overseas authorization cooperation, and the down payment set a record of 650 million U.
S.
dollars
.

The inflection point where volume and price fly together has also come

Biotech that does not tell the story of internationalization is not a good Biotech
.
It is undoubtedly the license-in/out that is closely related to internationalization.
In the past few years, the number of license-in has remained high.
Companies mainly use it to improve their R&D capabilities in the early stage, but then become some biotech "lazy" tools, license-in projects.
The price of the company is getting higher and higher, the quality is getting worse and worse, and the things bought by different companies are becoming more and more the same.
This year, companies that are purely license-in but have no self-research capabilities have become a problem on the science and technology innovation board
.
The license-out is "going out", allowing major international pharmaceutical companies to buy your project, which will test the gold content of innovative pharmaceutical companies
.

From relying on the input of foreign companies to now reversely importing them to foreign pharmaceutical companies, the blueprint for domestic innovative drugs to enter the international market gradually has a vague outline
.

So why can these "seamen" who seize the opportunity of the times get ahead? What useful experiences can be used for reference by latecomers?

- 01 - "the tide" approaches, pharmaceutical companies "back to the blood.
"

- 01 - "the tide" approaches, pharmaceutical companies "back to the blood.
"

Looking at the cross-border license-out of China's innovative drugs in the past two years, mature targets such as PD-1 and BTK, as well as popular areas such as ADC, CAR-T, and popular targets such as CD47 and SHP2, have been exported the most
.
The externally authorized pipelines are mainly late-stage clinical or listed products, which is the reason why the transaction amount has repeatedly reached new highs.
"Most of them are relatively close to the commercialization stage", OnCusp Therapeutics (OnCusp Therapeutics) co-founder, chairman and CEO Analysis by Dr.
Yuan Bin
.

Image source: Meibo Medical

Compared with license-in, license-out is the reverse output of Chinese innovative pharmaceutical companies
.

In the past few decades, the Chinese pharmaceutical industry has been chasing foreign companies, relying on the latter to "import" innovative drugs, and is in the pseudo-innovation stage of developing me-too drugs
.
Nowadays, China's new drug research and development strength has gradually been recognized by overseas markets.
Innovative products have entered the harvest period and have begun to move towards Best-in-class or even First-in-class hard-core "true innovation", as evidenced by the surge in the number of cross-border license-outs
.

This reversal took place in five years, and the joint catalysis of policies, capital and talents has changed the domestic pharmaceutical industry
.
If you carefully observe the cross-border license-out in the past 14 years, it is not difficult to find that since 2017, although the increase is small, the overall number is slowly climbing
.
In fact, this is related to factors such as China's official accession to ICH in June 2017 and related policy encouragement
.

ICH is an international meeting for the coordination of human drug registration technical requirements.
Its main purpose is to coordinate the standardization of the global drug regulatory system-similar to the WTO's role in national trade
.
WHO is considered the lowest standard in the world, while ICH is the lowest standard in developed countries
.

With China's accession to ICH, the reform of the drug review and approval system has gradually become in line with international standards, and China's drug regulatory system has begun to truly integrate into the regulatory system recognized by the international community
.

The capital market has stepped up its efforts to "open the gate", and the Hong Kong Stock Exchange's 18A and the fifth set of standards on the Science and Technology Innovation Board have opened up a more convenient channel for pharmaceutical and biological companies to IPO
.
It is understood that 42 new pharmaceutical companies went public last year, raising a total of approximately 56.
1 billion yuan
.
At the same time, the primary market's enthusiasm for investment in the pharmaceutical industry is increasing day by day
.
In 2020, a total of 947 financings occurred in the biomedical field, with a disclosed amount of approximately 208.
7 billion yuan
.

The influx of real money and silver just happened to hit the wave of overseas students returning to China for entrepreneurship
.
Most of them are the group of people with the best scores in the college entrance examination that year.
After studying abroad, they have almost worked in major foreign pharmaceutical factories for more than ten or twenty years, engaged in the research and development of innovative drugs
.
Because of this, "the companies they founded or joined are not much different from foreign countries in terms of innovative ideas and technology
.
"

Because of this, "the companies they founded or joined are not much different from foreign countries in terms of innovative ideas and technology
.
"

In addition to policies, capital and talents, the more mature domestic CRO industry has also pressed the accelerator key for the development of innovative drugs
.
CRO services can reduce drug R&D costs, shorten drug R&D cycles, and achieve rapid drug launches in a relatively short period of time
.
The development of this field benefited from the MAH policy (pharmaceutical marketing authorization holder system), which is also a relatively common international drug marketing and approval system
.

Prosperity also has two sides.
In the group of innovative pharmaceutical companies, there are many companies that have been matured by capital but whose strength is in question
.
Since the beginning of this year, the Science and Technology Innovation Board has vetoed the IPOs of many pharmaceutical companies and put more emphasis on hard technology attributes
.

It cannot be denied that policies are now squeezing the water of innovative drugs
.
In July of this year, CDE issued the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines" (draft for comments), which is about to tighten the traditional me worse and even me too
.
The background of this policy is that it is an indisputable fact that competition with target drugs has become fierce
.

In addition, with the substantial price cuts in medical insurance negotiations and the low-cost delivery effect of volume purchases, innovative drugs after the market are also facing the dilemma of squeezing the return space
.
The most representative one is PD-1, which is known as the cornerstone of immunotherapy.
Before medical insurance, the annual treatment cost of domestically produced PD-1 was about 200,000 yuan/year, which dropped to about 40,000 yuan/year, which was a big drop.
Someone once jokingly claimed that the price of cabbage was lowered
.
Compared to the cost of research and development of one billion US dollars of innovative drugs at every turn, it is not an exaggeration to say that it is the "cabbage price"
.

Judging from the semi-annual reports of the four major domestic PD-1 pharmaceutical companies, Hengrui Pharmaceuticals, BeiGene, Junshi Biological, and Xinda Biological are not as dazzling as expected in terms of heavy volume
.
Hengrui explained in its financial report with the worst performance in its history.
One of the important reasons for the negative revenue growth is that after the PD-1 implementation of the medical insurance negotiation price, it has dropped by 85%.
In addition, there are difficulties in entering the hospital and the implementation of medical insurance in various regions.
Time is different
.

"Medicine negotiations are thrilling.
The hospital controls the total amount of drugs entering the hospital, and your new drug comes in and squeezes out other drugs
.
A few years ago, some target markets felt large, but now they find that the market is small due to price cuts.
Severe price suppression is also detrimental to innovative drugs
.
" The CEO of an innovative pharmaceutical company told Deep Blue View
.

After nine deaths in the research and development of new drugs, innovative pharmaceutical companies discovered that entering medical insurance after listing is not an "iron rice bowl" that can bundle sales
.
Survival, to be precise, how to recover the cost and even have a good return, has become the next mountain they want to climb
.

Entering medical insurance after listing is not an "iron rice bowl" that can bundle sales
.
Survival, to be precise, how to recover the cost and even have a good return, has become the next mountain they want to climb
.

They have set their sights on overseas markets.
In fact, China’s current market share of innovative drugs only accounts for about 10% of the global market, and the remaining 90% of the international market has yet to be developed.
It can be said to have huge potential, of which only the sales amount in the US pharmaceutical market It accounts for 40%
.

"Innovative drugs can be profitable in the United States, and the price of the drugs is relatively high
.
Generally, innovative drugs can directly enter the commercial insurance after FDA approval (marketing)
.
" Yuan Bin told Deep Blue View
.

Innovative drugs can obtain huge returns in the US market, mainly due to a set of "patent protection + independent pricing + medical insurance" system
.
Among them, the medical insurance system has become a bottom-line existence.
Taking the structure of cancer medical expenses in the United States in 2014 as an example, cancer-related medical expenses in the United States were US$88.
7 billion, and patients paid nearly US$4 billion (approximately 4%)
.
Other expenses are jointly borne by commercial insurance, government medical insurance programs, and employers
.

In the above-mentioned cross-border license-out transactions in the past two years, a down payment of hundreds of millions of dollars and a milestone payment of more than one billion US dollars are enough to give an innovative drug company a "breathing" moment
.
With reference to R&D expenses that far exceed US$1 billion today, this amount of funds can share the R&D costs of the company to a certain extent, not to mention the subsequent sales commissions, which are mostly around 10% or even higher
.
Therefore, in the view of Dr.
Shen Huaqiong, CEO of Tianjing Bio, "Going abroad can enable the clinical and commercial value of new drugs to be realized as soon as possible
.
"

In addition, the overseas sales of domestic pharmaceutical companies are basically handed over to foreign companies to make up for their own shortfalls in overseas sales
.
This is also a smart way at present.
It is difficult for domestic innovative pharmaceutical companies to build their own overseas sales teams in a short period of time and compete with major international pharmaceutical companies
.
Foreign drug sales channels have long been mature, and the industry has long reached a consensus-if it is not sold through the international TOP20 pharmaceutical companies, the sales of the products will be impossible to talk about
.

There is a consensus in the industry for a long time-if it is not sold through the international TOP20 pharmaceutical companies, the sales of the product will be impossible to talk about

For a time, pharmaceutical companies in almost all major conferences and forums are propagating that they have to go international and fight for the right to speak in global innovation
.
"True innovation has to go international to be competitive
.
" Shen Huaqiong believes that going overseas is an important part of becoming an international pharmaceutical company, and license-out is almost a must
.

- 02 - License-OUT no shortcuts

- 02 - License-OUT no shortcuts

Not everyone can eat the “sweet and pastry” of the cross-border license-out
.

In June of this year, the National Medical Products Administration (NMPA) conditionally approved the listing of Vidicuzumab, which is suitable for HER2 overexpression locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) that has received at least two systemic chemotherapy.
) Treatment of patients
.

"In addition to the efficacy of RC48 as a single agent in the treatment of urothelial cancer, breast cancer, and gastric cancer, the combined treatment of RC48 and PD1 antibody is very effective in the treatment of first-line urothelial cancer, which is also of interest to the partner (Seattle Gene)
.
" Fang Jian Dr.
Min told Deep Blue View
.

At present, it has received FDA breakthrough therapy, which is also a good plus item
.
Make full use of the US FDA's priority notification policies, such as fast track, especially breakthrough therapies, so that the subsequent BLA (biological agent license application) declaration will be much simpler
.

Seattle Gene is the "invisible overlord" in the ADC field, and its ADC drugs account for more than half of the ADCs approved worldwide
.
ADC therapy has also become a "hot player" in anti-tumor therapy.
Many market institutions predict that the global ADC market will reach nearly 13 billion U.
S.
dollars in 2024, with a compound annual growth rate of approximately 35% from 2018 to 2024
.

As far as foreign pharmaceutical companies are concerned, they are not short of money, but innovation
.
If it is a very popular track, if you miss it, you will lose a big growth point, so even if it costs a lot of money, the big pharmaceutical companies will have to take it
.
"But a pharmaceutical giant like Novartis may look at its future sales, for example, whether it can reach more than US$500 million.
If it is too small, it may not be considered
.
" An industry source revealed
.

In addition, foreign pharmaceutical companies are still looking for a class of potential drugs that can complement and match their own pipelines
.
Shen Huaqiong introduced to Deep Blue View that the cooperation between Tianjing Biological and AbbVie was actually based on the latter's need to expand the pipeline in the field of hematoma
.
As its strong field, AbbVie's drugs in this field mainly include BTK inhibitor Imbruvica (Ibruvica) and BCL-2 inhibitor Venclexta (Venecla)
.
Previously, it also wanted to acquire Forty Seven, which is the main target of CD47, but it was unexpectedly listed by Gilead, who bought Forty Seven for US$4.
9 billion
.

In addition, foreign pharmaceutical companies are still looking for a class of potential drugs that can complement and match their own pipelines
.

CD47 is often regarded as the next important target in the field of tumor immunity after PD-1/PD-L1
.
At present, no product targeting CD47 has been approved for the market in the world, but more than 20 companies have deployed drug pipelines in this field
.

In order to rapidly develop drugs targeting CD47 targets, in September last year, AbbVie and Skyland Biotechnology reached a licensing agreement totaling nearly US$3 billion.
AbbVie will pay Skyland Biologics an advance payment of US$180 million and 1.
74 billion.
The US dollar milestone payment was obtained from the license right to develop and commercialize the lemzoparlimab (TJC4) monoclonal antibody lemzoparlimab (TJC4) in countries and regions outside of Greater China
.

CD47 monoclonal antibody (TJC4) is considered to have unique advantages.
It can bind to receptors on tumor cells and then attack tumor cells.
At the same time, it binds to red blood cells minimally
.
But many CD47 antibodies basically bind strongly to red blood cells, causing side effects such as severe anemia
.

In a phase I clinical trial conducted in the United States, TJC4 demonstrated its hematological safety advantages in cancer patients tested
.
"From preclinical trials, animal trials to clinical trials, we have proven step by step that it (TJC4) can overcome the hemolysis defect of red blood cells
.
" Shen Huaqiong explained
.
In addition, AbbVie believes that TJC4 and Venclexta in its own pipeline are potential therapeutic drug combinations
.

Like Tianjing Bio, the innovative pharmaceutical companies Jacos and AbbVie have also become partners
.
In June 2020, the two parties reached a license agreement for the total amount of approximately US$1 billion for the SHP2 project
.
Similar to TJC4 of TJC4, the SHP2 inhibitor of Jacos also cooperated with giants in the early stage of clinical practice
.

Phosphatase SHP2 is the main effector that mediates the downstream signal transduction of PD-1 in lymphocytes, and acts upstream of Ras in tumor cells.
It also has immunity and direct anti-tumor effects
.
According to the development plan announced by Jacos, SHP2 inhibitors can be used as monotherapy, or they can be jointly developed with PD-1 antibodies, MEK inhibitors and KRAS G12C inhibitors for various solid tumors
.

"We entered the clinic in the United States about half a year later than Novartis, and it is the second
clinical phosphatase target in the world .
SHP2 is the only clinical phosphatase target in the world
.
" Dr.
Wang Yinxiang, Chairman and CEO of Gacus Pharmaceuticals told Deep Blue View, and then the SHP2 inhibitors of American companies Revolution Medicine and Relay Therapeutic also entered the clinic
.

In his early years, Wang Yinxiang was well-known in the industry for his founding of Betta Pharmaceuticals.
Betta Pharmaceuticals successfully developed the first domestic targeted anti-tumor drug icotinib with completely independent intellectual property rights
.
In 2015, Wang Yinxiang turned to tumor immunotherapy, and once again established a business to establish Gax
.

"In fact, most of the major pharmaceutical companies wait and see for the early pipelines, and they will be selective for strategic layout reasons
.
" What Yuan Bin sees is that such a common pattern has been formed in foreign countries-small companies rush to the front.
When researching and developing new drugs, it is easier to be licensed-in or even acquired by major manufacturers when there are promising clinical data
.
"Small companies are more flexible when they dare to take risks in R&D, while large companies are more conservative and move slowly
.
"

Take Rongchang Bio-license-out ADC drug as an example.
It has obtained the FDA's breakthrough therapy designation, and its clinical data and safety data have been reviewed and determined
.
For the partner Seattle Genes, the certainty of this drug is already relatively large, and it can be declared and marketed in the United States by doing some bridging work
.

- 03 - how do the deal?

- 03 - how do the deal?

It seems that the initiative is in the hands of major pharmaceutical companies, but in fact, the forward-looking and proactive actions of innovative pharmaceutical companies have played a key role
.

It seems that the initiative is in the hands of major pharmaceutical companies, but in fact, the forward-looking and proactive actions of innovative pharmaceutical companies have played a key role
.

The executives of more than one innovative drug company emphasized to Deep Blue View that the importance of internationalization should be based on the establishment of a company
.
The establishment of R&D centers overseas and the "Sino-US Double News" for clinical trials have gradually become international standards
.

So, there is a strategic layout, how to land?

Fang Jianmin has a deep understanding of the internationalization of clinical trials.
Rongchang Biotechnology was established in 2008.
Early products lacked international preparation in pre-clinical and CMC work.
Some of the work did not fully meet the requirements of the FDA, and more work was needed.

.
"The current product development strategy is that the preliminary work must meet the FDA and EMA standards, and a little more money will be spent on CMC production quality and pre-clinical experiments
.
There will be a basis for thinking about going overseas in the future .
"

In the implementation of clinical trials, China, the United States and Australia can save time by starting at the same time.
In view of the long review time for the ethics and genetics office of phase I clinical trials in China, it will be faster to start the phase I climbing trial in Australia
.
Fang Jianmin concluded: "In general, we should get Western PK data and even some clinical data on safety and effectiveness earlier, so that we can speed up the advancement to international key clinical trials
.
"

In fact, these collaborations are not for the entrepreneurs to sit at home and wait, on the contrary, they have been actively traveling to and from various large-scale academic conferences
.
Shen Huaqiong said that as early as three or four years ago, when the company's self-developed innovative drugs had not yet entered clinical trials, they began to announce the characteristics of their own research and development products and the various trials they are doing and planning: "Let everyone know Your research and development capabilities, what you are doing, and the time point of clinical data generation
.
When you think this product is good, and then consider developing business cooperation, you may miss the best opportunity
.
"

These collaborations are not for the entrepreneurs to sit at home and wait, on the contrary, they have been actively traveling to and from various large academic conferences.

This is similar to Yuan Bin's view.
It is necessary to establish early contacts with companies that are interested in cooperation
.
"If you have a project that you want to license-out, you must talk to the other party in advance to seize the opportunity, (put this project) on his'radar'
.
When he wants to lay out your direction, he will I will think of you
.
" He used to serve as the Global Head and Executive Director of Merck’s Cancer Drug Business Development, and successfully completed 34 related mergers, transfers and Keytruda cooperation agreements
.
Earlier, he also held key positions in the marketing department of Novartis and Eisai
.

In addition, when developing drugs targeting CD47 targets, Shen Huaqiong often communicates with experts who develop similar targets
.
For example, at ASCO and ASH meetings, before the poster, she always communicates with her peers as much as possible, of course, mainly to exchange scientific opinions
.

In her view, this kind of communication is very important: "Knowing yourself and the enemy can better understand the strengths and weaknesses of others, and make yourself smarter
.
Some capable CMOs can work with research doctors through clever and practical clinical programs to resolve defects.
The research and development of the drug advances in clinical trials and avoids or reduces side effects
.
"

"If you want to see the opportunity of license-out, you can send an email to test the water first
.
" Meibai Capital partner Dai Youwen once said in a lecture, "For example, send 40 emails, how much feedback will you receive; feedback; Missing means that the product is not good or the preparation is not sufficient
.
"

In communicating with a group of interviewees, "communication" is one of the most commonly mentioned words.
The first is to maintain timely and transparent communication with partners
.
It took more than two years before the cooperation between Rongchang Biotech and Seattle Gene, and it was necessary to exchange the results of clinical trials at any time
.
"Data must be communicated whether it is good or bad.
The details of the contract require communication between various departments and levels, including direct telephone communication between CEOs, sometimes requiring the highest level of approval
.
" Fang Jianmin recalled
.

Shen Huaqiong also had a similar experience, "Regarding the license-out deal of the drug candidate, we have done countless rounds of communication and due diligence, first contact with the BD team, communication with the company's top management, then discussions between the scientists of the two parties, and the lawyers discussing the details of the contract
.
Sometimes, we and the BD team are basically sending text messages and making calls 24 hours a day
.
"

It is not easy to make new drugs, and it is even more difficult to make international new drugs
.
This is a systematic project that requires an excellent team, financial support, and actual combat
.

In addition to the "you come and go" between the two parties, Fang Jianmin also remembers the communication with the FDA
.
Companies often need to book a one-hour communication meeting a few months in advance, and there are often more than 20 FDA experts who will raise questions on the preclinical trials, clinical trials, pharmacology, and process quality of drugs on the spot
.
After a meeting, the minutes of the meeting may have dozens of pages
.
"A team that can have an equal dialogue with the FDA is very important, so returnees are very popular, especially those who have worked in the FDA
.
"

In addition to the "you come and go" between the two parties, Fang Jianmin also remembers the communication with the FDA
.

- 04 - "borrowed boat" is just beginning an international journey Long Way

- 04 - "borrowed boat" is just beginning an international journey Long Way

If nothing else, this year will witness the largest number of cross-border license-outs in history
.
License out has become an important way for unprofitable biotech companies to "recover blood"-withdraw funds and supplement R&D
.

Cinda Bio and Junshi Bio's drugs "going to sea" are good examples
.
In 2020, Cinda Biotech benefits from the licensing contracts signed with Etana and Eli Lilly for bevacizumab injection and sintilizumab injection (PD-1 inhibitor).
Only the licensing fee and service Xiang created 1.
476 billion yuan in revenue for the company
.
This directly reduces Cinda's loss in 2020 by 42.
0% compared to the previous year
.

Junshi Biotech and Eli Lilly have reached a licensing agreement on fully human anti-SARS-CoV-2 monoclonal neutralizing antibodies.
The technology license alone will generate 405 million yuan in revenue for Junshi Biotech (approximately a quarter of its main business income) 1); In February 2021, Junshi Biosciences reached an agreement with Coherus, a US pharmaceutical company, on teriprizumab (PD-1 inhibitor) and two optional items, which will receive up to US$1.
11 billion.
Related payments
.

In fact, license-out is an intermediate link in the internationalization of pharmaceutical companies and belongs to product internationalization
.
And the industry is recognized as the most difficult international sales , such as the establishment of overseas operating companies, set up overseas sales team and so on
.
The reality is that few domestic pharmaceutical companies can do this.
Even in foreign countries, the sales pattern of the pharmaceutical market has long been settled, and it is difficult for biotech to counterattack as almighty biopharma like Amgen and Genentech—not only Able to do scientific research, but also to make money in business
.

At present, the most difficult thing recognized in the industry is the internationalization of sales

Learning from each other's advantages to achieve a win-win situation may be the strategy for faster internationalization
.
If you hand over the overseas sales links that you are not good at to foreign companies, you will not only avoid sales expenses, but also get a net sales commission, and you may have tens of millions or even hundreds of millions of net profits into your pockets
.
Of course, whether it is "borrowing a ship to go to sea" or building a team, pharmaceutical companies have only one goal: to sell Chinese innovative drugs overseas
.

Learning from each other's advantages to achieve a win-win situation may be the strategy for faster internationalization
.

An undeniable trend is that License-out is entering an outbreak period
.
Not only cross-border transactions, but also transactions between domestic biotech and biopharma and big pharma have begun to emerge
.
In the past, Hengrui, which had little interest in domestic biotech, reached a pipeline cooperation with two pharmaceutical companies this year alone
.

For domestic innovative drug companies, cross-border license-out is a recognition of strength
.
But it should also be admitted that this recognition is currently only a minority
.
Compared with developed countries in Europe and America, China's medical innovation is still far behind
.
"If the United States' ability to create new drugs is regarded as the Qinghai-Tibet Plateau, then our country's ability in this field can only be equivalent to Guilin.
Although there are some independent peaks, the overall difference is far
.
" Liu Jianya, CEO of China Huasheng Biopark once described it.
Over
.

"If the United States' ability to create new drugs is regarded as the Qinghai-Tibet Plateau, then our country's ability in this field can only be equivalent to Guilin.
Although there are some independent mountains, the overall difference is far
.
"

In terms of the number of innovative drugs, from 2014 to 2019, the United States produced an average of 43 innovative drugs each year, while China only produced 4.
2
.
At present, there are 20,000 innovative drugs under research in the world, 50% of which are in the United States and only 3% in China
.
According to McKinsey's 2016 analysis data, the United States contributes 50% to global pharmaceutical research and development, while China contributes less than 5%
.

Policies are forcing the pattern of domestic innovative medicine ecology.
The “4+7” mass purchase promotes generic medicines to be “people do not own, and others have my advantage”.
Medical insurance negotiations encourage rapid increase in volume of innovative drugs through medical insurance
.
Guo Yunpei, president of the China Pharmaceutical Enterprise Management Association, predicts that by 2022, China's generic drug companies will decrease by 1,000
.

Few companies have successfully gone overseas, and most of them are the embarrassment faced by pharmaceutical companies that are far from the spotlight
.
They also want to go overseas, but their me-too/better products are not the protagonist of cross-border lincense-out
.
Only by making truly innovative drugs, such as first-in-class and best-in-class, can it stand out and become a truly international pharmaceutical company
.