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When selling core products, selling factories, laying off teams, and unable to rent offices were flooded with all kinds of "winter" news, an innovative pharmaceutical company quietly appeared on the global pharmaceutical map, giving the industry an unexpected surprise
.
On November 2, Generics, the global authoritative journal of generic drugs and biosimilars
Bulletin unveiled the "2022 Global Generic and Biosimilar Awards", Henlius won the "Business Development of the Year Award" from hundreds of companies for its outstanding performance in global cooperation growth, and the nominees at the same time included Sandoz, Accord, Dr.
Reddy's and other well-known pharmaceutical companies
.
"Despite the pandemic, Henlius has demonstrated efficient and resilient business expansion capabilities with impressive success, placing a deep Chinese mark
on the global biosimilar development map.
" The jury of the award praised Henlius' commercial development capabilities
in biosimilars.
in biosimilars.
These reviews are based on Henlius' strong license in the first half of the year
In terms of objective statistics, Henlius is a BD "pioneer" that carries the banner worldwide
.
In the first half of 2022 alone, Henlius completed 4 licenses
OUT transaction, ranked in the domestic license
The first place
on the OUT list.
In terms of amount, Henlius and Organon reached a license in June this year, with a total transaction amount of US$541 million and a down payment of US$73 million, setting a new record
for a single transaction of biosimilar licensing in the world in the past five years.
For Henlius, this is another Chinese brand
in the global biosimilar industry, following Hanquyou becoming the first "Chinese" monoclonal antibody biosimilar to land in Europe.
From the internationalization of products to the internationalization of the company's brand, Henlius' voice overseas has expanded, and China has more possibilities
to overtake on biosimilars.
As we all know, most of the overseas expansion of biopharmaceutical companies at this stage is completed in the form of
license out transactions.
As of now, the domestic license
The development of OUT trading has gone through three stages
.
The first phase is annual licenses until 2012
The number of OUT transactions is in the low single digits; The second stage is 2013~2018, and the number of transactions per year reaches high single digits to low double digits, which is in the start-up period; After 2018, it entered the third stage of rapid development, License
Both the number and amount of OUT transactions have increased
exponentially.
Henlius is one of
the leaders.
According to statistics, in the first three quarters of 2018~2022, a total of 107 new product licenses occurred in the industry
Out transactions, Henlius completed 12 transactions during the same period, contributing more than 10%, becoming a license in Biotech
The highest
number of OUT transactions.
Remarkably, Henlius completed the annual license during this period
The number of OUT transactions is stable, for example, in 2018, there were only 15 transactions of this type in the industry, of which Henlius accounted for two seats; In the first three quarters of 2022, there were 24 events in the industry, and Henlius occupied four seats
.
number of OUT transactions.
01 Take different paths of internationalization
Take a different path of internationalizationIn recent years, China has been immersed in "pursuing source innovation but the essence is in Me.
"
In the atmosphere of "struggle in too", the entire industry is not optimistic
about the model of innovative pharmaceutical companies starting from biosimilars.
However, Henlius has penetrated the global market with its continuous accumulation, and now it has fought a beautiful battle in internationalization with biosimilars, truly refreshing the industry's cognition
.
In fact, not only the external authorization of products, but also the overseas listing of products and international multi-center clinical trials, which are important indicators for evaluating the internationalization, Henlius is a pioneer on the internationalization of biopharmaceuticals in China
.
Looking at the enterprises that have been exploring internationally at this stage, there are three magic weapons, "see, think and do"
.
Specifically, the first is the international vision written in the genes, followed by the internationalization strategy that matches itself, and finally the execution ability
with rich experience.
Henlius is no exception
.
In an interview, the manager of E drug once asked Henlius what Henlius' dream was, and its founder made a figurative analogy, "enter the World Cup"
.
Therefore, internationalization has been written into Henlius' DNA from day one, and through continuous accumulation, the perfect international innovation research, production and marketing integration platform has become a solid foundation
for Henlius to go global.
Many real-world examples are also illustrating this fact, and if you want to make innovative drugs, you must be international.
Although the slogan of "internationalization" is pervasive in the industry, everyone agrees that "if internationalization is only words, it is not necessary
.
" ”
Henlius is a practitioner
.
Taking Hanquyou as an example, according to Henlius, the drug was developed and produced in accordance with the relevant regulations of China and the EU biosimilars from the beginning, and the phase III clinical trial of Hanquyou is a large-scale international multi-center clinical trial
.
It is understood that its Xuhui production base is the first GMP factory
in China to obtain EU GMP certification for the production of self-developed antibody biological drugs.
At present, Hanquyou has not only covered more than 100 countries and regions, but also successfully approved in more than 30 countries such as China, the European Union and Australia, truly landing overseas and benefiting patients
around the world.
Vision determines the height of the enterprise, and strategy guides the way
to achieve the goal.
The internationalization of domestic biotech is basically crossing the river by feeling the stones, and only a few companies have broken out of the internationalization path
suitable for themselves.
Henlius is a benchmark on a road, and his path is to "take the lead with biosimilars, achieve the ultimate biosimilars, and pave the way for innovative drugs that follow closely behind"
.
to achieve the goal.
On the other hand, its strategy and style of play to go to sea are also different
.
From the completed transactions, Henlius' overseas products are almost all selected with different partners in different regions, which makes it have more than ten partners
for its four or five products.
In general, domestic about the license of the product
The regions of OUT transactions are the transfer of global interests outside of Greater China or outside Asia Pacific to one or two partners
.
According to Henlius' reply, the company has now achieved the external authorization of two biosimilar drugs under development and all four biosimilar products on the market, and the maturity of biosimilars in various markets around the world is not the same
.
Overall, Henlius prefers to find local commercial networks, localized teams, and excellent tracks
Record's partners, but the choice of partners in different markets must also be tailored to local conditions
.
"For example, the biosimilar market in Europe is very mature and competitive, and we chose a partner with Accord
, which has a fairly successful sales experience in Europe and is doubling every year.
In some countries and regions, such as Brazil, local companies will have more advantages
.
”
Henlius believes that this model can maximize the commercial value of biosimilars and enable affordable innovation
.
In the process of internationalization, more and more Biotech sees the huge population base and potential of emerging markets, and expands its vision from European and American markets to emerging markets
.
Based on the low ability to pay in emerging markets compared to developed countries, biosimilars are indeed a good entry point in theory, allowing more patients in emerging markets to use affordable and high-quality biological drugs
.
.
02 Innovate and find the blue ocean from the red ocean
Innovate and find the blue ocean from the red oceanFor biopharmaceutical companies, innovative drugs are the constant pursuit
.
Compared with other first-tier innovative pharmaceutical companies, Henlius' innovative drugs have not started early, but they have not fallen behind in the market competition of many peers
.
It is worth mentioning that despite Henlius' first innovative drug product, H drug
Hans is the 13th PD-(L)1 product on the domestic market, but it has not encountered the embarrassing situation of its "predecessors", and has "emerged"
with differentiated data and commercial performance.
Since the launch of its first product, Henlius, Henlius has promoted the commercialization of 5 products, including 4 biosimilars and 1 innovative drug
, in the past three years.
As of June 30 this year, Henlius achieved revenue of nearly 1.
3 billion yuan in the first half of the year, mainly due to revenue
generated by the continuous commercialization of its products.
Among them, Hanquyou sold about 800 million yuan in the first half of the year, and is about to become one of the few large varieties
with annual sales of more than 1 billion yuan.
With this commercialization result, the industry estimates that Henlius is expected to become one of the top 3
innovative biopharmaceutical companies.
innovative biopharmaceutical companies.
Henlius, which starts from biosimilars, is basically stable and full of expectations
.
This is not empty lips
.
It has to be said that after all, products still need to use data to speak and use market performance to verify strategies
.
Henlius also has a deep understanding of this, so he chose to make the longboard longer - mainly focusing on the first-line coverage of large cancers in the layout of indications, ingenious in molecular structure and clinical strategy, making differentiation, making eye-catching data that cannot be ignored, "settling down" in the domestic market with good efficacy and potential breakthrough treatments, and copying the commercialization experience established in the development of biosimilars to innovative products and accelerating them to market
.
.
March 2022, H drug
Hans-like (serplulimab) was officially approved for marketing, and achieved sales of about 77 million yuan in 3 months of listing, and the institution expects sales between
2~300 million yuan this year.
At present, H drug has been approved for the treatment of microsatellite highly unstable solid tumors and squamous non-small cell lung cancer in 2 indications, 2 indications marketing applications have been accepted, and 11 clinical trials have been carried out
simultaneously worldwide.
While ensuring the steady development of the domestic market strategy, Henlius has never stopped laying out the road
of innovative drugs to the sea.
2~300 million yuan this year.
As early as a few years ago, Henlius prospectively laid out the international multi-center clinical trial of H drug, and the cumulative enrollment of H drug has exceeded 3,100 people in China, Turkey, Poland, Georgia and other countries and regions, of which the proportion of white people enrolled in two international multi-center clinical trials exceeds 30%.
This year, Henlius got it right, and its forward-looking international vision and thinking have opened the door
to the global market for H Medicine.
Since 2022, many domestic PD-1s have been folded in the FDA, and then the industry has reached a consensus
that "PD-1 without differentiation is difficult to be approved for marketing in the FDA, and PD-1 without international multi-center clinical trials is difficult to be listed in the FDA".
Rarely, Henlius' H drug is a product with both differentiated indications and large-scale international multi-center phase III clinical trials, and has become a very competitive existence
in the vast domestic PD-1 overseas army.
The most anticipated indication for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) with H drug combined with chemotherapy is expected to become the first
in the world.
It is understood that H drug is the world's first anti-PD-1 monoclonal antibody
with positive results for the first-line treatment of small cell lung cancer.
in the world.
Currently, H drugs for the treatment of SCLC have been recognized as orphan drugs by the US Food and Drug Administration (FDA) in April 2022
.
At the same time, based on the positive feedback and FDA submitted by the FDA for the marketing application of H drug treatment ES-SCLC
As a result of the discussions at the Class C Advisory Meeting, Henlius will initiate a bridging clinical trial in the United States and intend to submit a corresponding marketing application
in the United States in the first half of 2024.
Henlius said, "This also benefits from the company's international development experience in biosimilars, which has established a benchmark with the regulatory standards of mature biological drug markets, and has explored a set of successful experience in operating international multi-center trials, which has become one of
Henlius' advantages in going overseas.
" ”
On November 17, Henlius announced that it entered into a license agreement with Fosun Pharma Group to grant it an exclusive commercial license
to H drugs in the United States.
Under the agreement, Henlius will receive an initial payment of RMB1 billion and a regulatory milestone payment of US$50 million, as well as sales milestone payments
based on annual net sales.
to H drugs in the United States.
Conclusion
ConclusionThe innovation, transformation, upgrading and internationalization of the industry are a long road, and it is impossible to rush, and innovation for the sake of innovation will inevitably fail
.
And real innovation should not be a narrow sense of technological innovation, it needs to be defined and accepted
from the use side.
When the targets are becoming more and more limited, some companies are bound to face homogeneous competition, how to find the blue ocean in the red sea, Henlius is a good example
at present.
Biotech becomes Biopharma, R&D capabilities, production capacity and commercialization capabilities are indispensable, especially for enterprises
that want to take the international route.
