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Growing into a biopharma is almost every Biotech's dream, and in the eyes of many Hong Kong-listed biopharmaceutical companies, tearing off the "B" logo is an important step
for them to grow into Biopharma.
The 18A of the Hong Kong Stock Exchange has been open for more than 4 years, and there are more than 50 biopharmaceutical companies listed, but only 6 have successfully "picked B"
.
18A enterprise
"Pick B" needs to meet the conditions of annual revenue of more than HK $500 million and market value of more than HK $4 billion, for this standard, the industry generally understands that it is actually a consideration
of profitability, product R&D pipeline, and commercialization ability.
Therefore, the smooth removal of the "B" logo is also regarded as an important indicator
of the growth of a Biotech.
Among the 18A Hong Kong stocks, the first to "pick B" were the "three tigers" who started with PD-1: Baekje, Cinda, and Junshi ; Since then, Henlius, which focuses on biosimilars, and CanSino, which has eaten the dividends of the vaccine industry, have also followed suit to tear off the "B" logo
in 2021.
With Zai Lab's announcement on November 11 that its stock code suffix -B was officially cancelled, the domestic Biopharma club has also added another general
.
Liang Yi, Chief Commercial Officer and President of Zai Lab, Greater China, is confident: "This is an important step
for Zai Lab to grow into Biopharma.
"Zai Lab, which has commercialized four innovative products in the 8 years since its establishment, has done the right thing on its way from Biotech to Biopharma?
.
Liang Yi, Chief Commercial Officer and President of Zai Lab, Greater China, is full of confidence:
01 Powerful "hematopoietic" ability
Powerful "hematopoietic" abilityThe most important feature that distinguishes Biopharma from Biotech is its
ability to commercialize.
If you put a timeline for China's biotech development, 2018 is the first year
for a group of leading innovative pharmaceutical companies to start commercialization.
Now, four years have passed, and the focus of competition of leading innovative pharmaceutical companies has gradually shifted
from new targets, new technologies and early R&D to the late R&D stage and even commercialization.
For innovative pharmaceutical companies that have entered commercialization, "how to do a good job in commercialization and how to really land new drugs" is an important step
in whether they can truly grow into a biopharma.
Specific to Zai Ding, "This successful 'B' is an important symbol
that the company has passed the initial stage of Biotech, entered Biopharma, and its commercialization ability has been recognized.
" Liang Yi said
to the E drug manager.
Especially under the current "haze" of capital winter, the narrowing of the financing window makes the commercialization of innovative products more important
.
Since the launch of the first product, Zeile, Zai Lab has started a "commercialization storm"
that lasted for more than 2 years.
.
Since the launch of the first product, Zeile, Zai Lab has started a "commercialization storm"
that lasted for more than 2 years.
In December 2019, the State Food and Drug Administration approved Zeile for maintenance therapy for platinum-sensitive recurrent ovarian cancer; In May 2020, EPDUN, a tumor electric field therapy device for the treatment of glioblastoma, was approved for marketing; In March 2021, Qingle was approved for advanced gastrointestinal stromal tumors in China; In December 2021, Nuzale was approved by the NMPA for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI
).
In less than 24 months, Zai Lab has launched four innovative products in China, which is surprisingly fast, but it is also a huge test
of its commercialization ability.
In the face of the huge demand for the commercialization of innovative drugs, Liang Yi said: "Zai Lab's commercialization team has a very important mark is specialization, at present, the products we promote are in the field of oncology, which means that there is a professional team in each field of cancer, such as gynecological oncology and gastrointestinal oncology
.
As more and more of our products are approved in the future, we will also set up a corresponding specialized commercial team to promote
them.
"For every Chinese innovative pharmaceutical company that wants to become a biopharma, medical insurance is an inescapable topic, and from the sales performance of the core products of several domestic innovative pharmaceutical companies after entering medical insurance, medical insurance has become an important driving force
for innovative drugs to quickly seize market share and achieve volume after they are launched.
"
Active participation in health insurance negotiations is one of
the most important ways for Zai Lab to bring innovative drugs to market and make them accessible to patients.
As Zai Lab's first commercial product, Zeile (niraparib) was approved for marketing in December 2019 and entered the medical insurance catalog
through medical insurance negotiations in 2020.
According to the data disclosed in Zai Lab's 2021 annual report, Zele achieved sales revenue of US$93.
58 million in 2021, a year-on-year increase of 190.
68%, providing the driving force
for its revenue growth in 2021.
Zai Lab successfully expanded the coverage of Zeile's medical insurance indications to first-line maintenance treatment of ovarian cancer in the 2021 medical insurance negotiations, "Zeile is not only Zai Lab's first listed product, but also the only PARP inhibitor in China that can be used for the maintenance treatment of ovarian cancer in the whole population, and the relevant indications have entered the national medical insurance catalog, which greatly accelerates the admission and volume of the product in 2022," Liang Yi said
.
Liang Yi said that medical insurance negotiations are very important for Zai Lab, and for the upcoming health insurance negotiations this year, Zai Lab said that there are two products participating in the negotiations, namely Qingle, a product for the treatment of gastrointestinal stromal tumors, and Neozaile
, an anti-infective drug.
, an anti-infective drug.
The entry of innovative drugs into medical insurance is only the "first step" to commercialize and achieve patient access, and the promotion after admission is equally important
.
Liang Yi revealed in a previous interview with E drug manager that after Zele entered the national medical insurance catalog at the end of 2021 as an indication for the first-line treatment of ovarian cancer, its market share has steadily increased, and as of the third quarter, the number of hospital admissions has exceeded 1,800, which continues to remain at the industry-leading level
compared with the products included in the medical insurance catalog in the same period.
In addition to actively participating in national health insurance negotiations, Zai Lab is also making innovative drugs accessible to patients through diversified payment methods for commercial health insurance such as Huimin Insurance
.
As China's first and only innovative medical device covered by urban inclusive insurance, according to Zai Lab's third quarterly report, Ep Shield has been included in 72 cities covered by universal insurance, most of which can achieve reimbursement with sick bodies, according to a report released by Fudan University, Ep Shield ranked second among all special drug compensation products of Huimin Insurance, and sales revenue continued to grow
.
Zai Lab's exploration of the commercialization of innovative drugs has achieved initial results, and its commercialization capabilities are directly reflected in the company's rising performance
.
According to the financial results for the third quarter of 2022 released in mid-November this year, Zai Lab's total revenue reached US$57.
5 million, an increase of 33% year-over-year and a quarter-over-quarter increase of 19%.
Specifically, Zai Lab's continued growth in sales revenue is led by its blockbuster ZEILE oncology product, which is currently the only PARP inhibitor
approved in the United States, the European Union and China that can be used monotherapy for first-line maintenance therapy of advanced ovarian cancer, regardless of the patient's biomarker status.
.
During the reporting period, Zeile contributed $39.
2 million in net income to Zai Lab, an increase of 15%
quarter-over-quarter.
The results of commercial exploration are inseparable from clinical advantages and differentiated product pipelines
.
According to Yan Shuizhong, chief operating officer of global R&D at Zai Lab, in the next 2-3 years, Zai Lab will enter the outbreak stage of pipeline approval, "It is expected that there will be 8-10 products, and about 15 indications will be approved
in China.
" "Obviously, the steady stream of innovative achievements will be a continuous driving force
to support the development of Zai Lab's commercialization capabilities.
02 An open innovation model that is difficult to replicate
An open innovation model that is difficult to replicateThere are many companies in the industry that want to "copy" Zai Lab, but it is not easy to achieve Zai
Lab's success.
In the eight years since its inception in 2014, Zai Lab has built 28 differentiated, potentially best-in-class or best-in-class innovative product
pipelines.
Among them, 4 varieties have been commercialized, 13 products are in the late-stage clinical research and development stage, and at least 9 products have global rights
.
Zai Lab's dazzling report card benefits from Zai Lab's two-wheel-drive innovation model
of "internal independent R&D + external strategic cooperation".
Yan Shuizhong calls this model "open innovation", which is also the path Zai Lab has chosen since its inception, and even led the "trend"
of open innovation in China.
New drug research and development has the characteristics of "high risk, high investment, long research and development time, and low output, as a system engineering, new drug research and development needs to combine
science and application.
" In this process, what is most needed is "cooperation"
.
In Yan Shuizhong's view, only cooperation can "gather momentum and stand up", and only cooperation can make breakthroughs
.
If we look at the global pharmaceutical R&D industry chain, nearly 70% of the product pipelines of the world's top 10 pharmaceutical companies are obtained through open innovation of self-research + cooperation, and less than 30% of the innovation comes from within
the enterprise.
This kind of open innovation is essential
to reduce the cost and risk of new drug development, and accelerate the efficiency and process of new drug development.
New drug research and development is more like a relay race, which requires the joint efforts of "production, learning, research and medicine"
.
It is necessary not only to have the independent innovation of pharmaceutical R&D enterprises, but also to cooperate with academic institutions such as universities and research institutes and clinical clinics to gather advantages
.
Yan Shuizhong believes that independent research and development and external introduction are not antagonistic relationships, but complementary behaviors
.
For example, he said, "Some of the innovation of new targets is done by small biotechs or research institutes, who have been deeply engaged in a certain track for many years and have rich experience, but in terms of drug development, it is something that pharmaceutical companies like Zai Lab are better at, and the cooperation between the two parties can greatly improve the efficiency and success rate
.
" ”
.
Yan Shuizhong pointed out that Zai Lab's advantage lies in communicating with regulators and clinicians faster, formulating R&D strategies accordingly, and then quickly connecting with medical insurance and the market to get the drug to meet the needs of patients as quickly as possible
.
"In this relay race, all parties need to focus their limited resources on important projects to bring innovative drugs to market
as soon as possible.
"
as soon as possible.
"
Yan Shuizhong said
.
To a certain extent, Zai Lab's open innovation is constantly changing
with the development stage of the company and the domestic pharmaceutical market.
In a previous interview with E drug manager, Yan Shuizhong revealed the "short, medium and long-term strategy of Zai Lab Open Innovation"
.
At the beginning of its establishment, Zai Lab mainly introduced and registered urgently needed products from abroad through the authorized introduction model, so as to benefit patients as soon as possible; From the perspective of medium-term strategy, it is to promote early products with independent research and development and external cooperation to clinical trials; The ultimate long-term goal is to bring all R&D products to the global market
.
Yan Shuizhong emphasized that no matter what stage it is in, Zai Lab always adheres to the concept of clinical needs and patients first to develop innovative treatments
.
"This purpose never changes"
.
Yan Shuizhong revealed that Zai Lab always adheres to three principles
when introducing external products.
First of all, the product must be the world's first or the world's best, which is Zai Lab's quality requirement for the imported products; Secondly, the indications belong to the huge unmet clinical needs in China, which are in line with the Chinese disease spectrum and are urgently needed by Chinese patients; Third, the products introduced and the products in the company's existing pipeline can create synergies, and achieve the effect of 1+1>2 through joint use
.
R&D investment is an important indicator to measure the R&D level of pharmaceutical companies, and the growth of R&D investment also represents to a certain extent that a pharmaceutical company has entered an accelerated period of innovation, and Zai Lab is in such an accelerated period of innovation
.
when introducing external products.
Looking back at the R&D expenditure in the past three years, it has always maintained rapid growth, which is also Zai Lab's investment
in the future.
For Zai Lab, which is rapidly improving its self-research capabilities of innovative drugs, focusing on providing global patients with the first and best innovative treatment methods is the direction
of its self-development.
Through internal R&D and external collaborations, Zai Lab has established a differentiated pipeline portfolio
in four therapeutic areas: oncology, autoimmune diseases, infectious diseases, and central nervous system diseases.
03 Maintain strategic concentration in the cold
It is also necessary to maintain strategic concentration in the coldIn the next two to three years, at least 8 products will be approved for marketing
in Greater China.
This is the development goal
Zai Lab has set for itself.
In Liang Yi's view, Zai Lab has a clear pace of development
.
He explained to the manager that Zai Lab's first stage was to have a good product pipeline, "just as the company introduced products like Zeile at the beginning of its founding
.
" ”
.
He explained to the E drug manager that the first stage of Zai Lab's development is to have a good product pipeline.
The second stage is the commercialization
of innovative products.
"With the approval of ZEILE's second-line indications and first-line indications and entering medical insurance, including the later introduction of products such as EPDUN and Qingle, the 2.
0 stage in which Zai Lab is located has developed rapidly, which is why it can "go to S and go to B"
successively in 2022.
For Zai Lab, which has entered version 3.
0, Liang Yi is full of confidence
.
He said that Zai Lab has been very smooth
in its journey towards the 3.
0 development stage.
At the capital level, Zai Lab has successfully listed in China and the United States, and has "rich food and grass" for enterprise development through the favor of the capital market; In terms of talent, Zai Lab has set up 8 operation offices around the world, and talents have global vision and rich experience; At the pipeline level, Zai Lab has established 28 differentiated, potentially first-in-class or best-in-class innovative product pipelines, four of which have been commercialized
.
In addition, Zai Lab has a number of early-stage R&D projects covering multiple cutting-edge targets, such as CCR8, Claudin18.
2, DNA-PK, etc
.
Indeed, the continuous hematopoietic capabilities demonstrated by a number of commercialized products, the continuous implementation of innovation achievements under the open innovation model, the management team with global vision and rich experience and the corresponding talent pool have laid a solid foundation
for Zai Lab to move forward steadily.
Although since the second half of this year, the valuation of the primary and secondary markets has been lowered, and the "cold" of the capital market has made the industry "everyone at risk", but in Liang Yi's view, although the current development of the domestic biomedical industry has slowed down compared with the previous two years, the more headwinds it is, the more we must maintain strategic concentration
.
"In other words, do the right thing
.
"
Liang Yi bluntly said that for pharmaceutical companies, the most correct and important thing is to serve
patients.
"Whether it is health insurance negotiations, market access, or improving patient access and doctors' awareness of the disease, Zai Lab is the most important thing
for Zai Lab as a pharmaceutical company.
" Liang Yi said that insisting on doing the right thing also ensures that Zai Lab can be down-to-earth
at every stage of development.
In the face of valuation reduction and financing winter, Zai Ding people have never panicked and been anxious
.
In Zai Lab's eyes, the share price in the secondary market cannot be equated
with the value of the company.
Yan Shuizhong said: "We have always believed that as long as there are breakthrough products, as long as these products can meet the unsolved clinical medical needs, meet the needs of patients, and meet the market needs, our value exists
.
”
