Zebutinib is expected to hit the blockbuster for 3 years on the market, PD-1 stands out, and what did BeiGene do right?

In China, the commercialization of innovative pharmaceutical companies is a protracted battle, winning at the beginning may not necessarily win at the end, and long-term sustainable development is more worth looking forward to

According to the statistics of E-drug managers, since 2018, 26 Biotech companies have achieved commercial listing

BeiGene is one of the first Biotechs to enter commercialization, how can it stand out and change the competitive landscape in the fierce battle of domestic PD-1? Zebutinib sales exceeded 1.

01 Commercial Street Fighting: How Baekje Breaks Through

PD-1 is a milestone product of domestic biological innovation drugs, known as the "king of volumes", and is also the epitome

At present, there are three main types of players competing around PD-1 products, multinational pharmaceutical companies, traditional large pharmaceutical companies, and the newly promoted Biopharma, and the strategies and layouts of each pharmaceutical company in the commercialization of PD-1 are also different

Second, Baekje has avoided the serious homogenization of the indications to a considerable extent in the promotion of the indications, and tried to strive for the first one on the indications

The third is to actively promote access

In the future, whether it is from the perspective of the number of indications of the layout or the progress, the commercial potential of tirelizumab is undoubtedly more imaginative

In the first half of this year, Baekje's zebutinib reached global sales of 1.

Zebutinib is most highly anticipated for the approval of the indications for chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), which is a "must-see" in the BTK field and has a lot

Huaxi Securities expects that with the approval of various indications as scheduled, the global sales of zebutinib in 2023 may exceed 6 billion yuan

Whether it is tirallizumab or zebutinib, it is a preliminary verification

It is worth noting that in the first half of this year, Baekje's global commercialization pace is the next city, expanding production and construction to the United States, in addition to the already built production bases in Suzhou and Guangzhou, China, at the end of April, the company announced that the commercialization stage of biological agent production and clinical research and development center established in New Jersey officially broke ground

02 International Perspective: It is difficult to build a Baekje

Baekje at this stage may be enviable, but it is difficult for the industry to recreate a Baekje

Baekje has many products in its pipeline, but through strategic focus, it is currently focusing on the field of oncology, and several of the core products under development include: terelizumab, zebutinib and TIGIT monoclonal antibody

In the case of zebutinib and terelizumab, the continued investment has resulted in a broad clinical layout
.
In the first half of the year, zebutinib obtained 13 new drugs or new indications for marketing applications in Switzerland, South Korea, Mexico and other countries, and at present, zebutinib has been approved
in more than 50 markets such as the United States, China, the European Union, Canada, and Australia.
As of August this year, zebutinib also has more than 40 pharmaceutical applications for multiple indications worldwide under review, including important indications CLL/SLL
.

Tirelizumab has also initiated or completed more than 20 potentially registered clinical trials in China and globally, including 17 Phase 3 clinical trials and 4 critical Phase 2 clinical trials, and as of August, more than 11,000 subjects from 30 countries have participated in the clinical trial
of tirelizumab 。 These clinics will be used to support the global filing of terelizumab, and baekje/Novartis submitted a marketing application for the first indication of terelizumab in the United States in the first half of the year for second-line treatment in patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC), although this approval has been delayed due to the impact of the epidemic and the FDA has not yet provided an updated date
.
In addition, terelizumab has also submitted listing applications in the European Union, the United Kingdom, and Australia, all of which are currently under
review.

In the first half of this year, a number of domestic PD-1s were blocked in overseas listing, and the industry was worried
.
However, some former FDA review experts believe that the FDA has not questioned and supplemented the clinical data of tirelizumab, which means that the clinical data is fine, and the next step mainly depends on the time of
on-site verification.
Next, the clinical data obtained from terelizumab will also be used to support the
2023 Novartis program submission in the United States for first-line gastric cancer, first-line and local treatment of esophageal squamous cell carcinoma (ESCC) and first-line treatment of hepatocellular carcinoma (HCC).

It is worth noting that most of the clinical costs of zebutinib and terelizumab are spent on international multicentre clinics
.
As we all know, the ceiling of the domestic market can be seen, and it is difficult to cultivate the "blockbuster" variety in the existing market space, so whether a differentiated product can move towards internationalization has become the key
.
Baekje is the first innovative pharmaceutical company to carry out registered clinical trials simultaneously in China and overseas, and baekje has launched more than 100 clinical trials in more than 45 countries and regions around the world, and more than 60% of the studies are international multi-center clinical trials; About half of the more than 16,000 subjects recruited in the clinical trial were enrolled outside Of China
.

This is fundamentally different from the "establishment of overseas offices, with 'independent clinical + clinical CRO' attached equal importance to, and even rely on the latter" where most pharmaceutical companies are located
.
Baekje not only has a large international multi-center clinical team, but also has a clinical team that can independently operate global clinical trials and a pharmaceutical registration team that is familiar with national regulations
.
Baekje's global clinical development and medical affairs team currently has more than 2,500 employees
.
This difference is actually an important barrier in the internationalization of pharmaceutical companies, because the implementation of clinical trials by enterprises themselves can maximize the quality and progress
of clinical trials.

It is no accident that Baekje was able to build such a large and well-established global team, but because of its judgment of the overall situation and its courage to take the lead
.
Around 2016, the speed of clinical approval of new drugs in the pharmaceutical policy reform was greatly accelerated, and the key work of Baekje began to focus on the clinical end
.
Under this opportunity, Baekje gradually established a domestic clinical team and expanded
it on a large scale.

At that time, the high-end clinical talents in the industry were in multinational pharmaceutical companies, and the atmosphere of clinical talents flowing into innovative pharmaceutical companies had not yet been opened, in order to attract more people to join Baekje, the company vigorously recruited R&D talents
in the industry.
Wang Lai, head of global research and development at BeiGene, once introduced in an interview that at that stage, he "told stories" to various people over and over again, told his views on the industry, talked about the spring of China's innovative drugs, and talked about the historic opportunity to create a career, hoping to let more like-minded people join Baekje
.

Until the beginning of 2019, Baekje's Asia-Pacific development team with the Chinese clinical team as the team was basically formed, and the company turned around and began to establish a clinical development center
in the United States.
Over the course of six years, Baekje has gradually built a high-execution team
that focuses on both China and the United States, while laying out clinical operations and pharmaceutical registrations in other parts of the world.
Managing global multi-regional clinical trials through this in-house team not only enables faster onboarding of patients, but also significantly reduces the time and cost of clinical development of candidate products
.

In addition to commercialized, self-developed drugs, BeiGene has nearly 40 clinical-stage candidates and commercial-stage products
.
At present, the company is steadily advancing a number of independent research and development projects in the early clinical stage, including BCL-2, OX40, HPK1, TIM-3, PI3Kδ and TYK2
.
In the second half of this year, the TIGIT project Osperliumab, which is already in clinical phase 3, is expected to launch a new critical clinical trial, and another key clinical trial of BCL-2 inhibitor BGB-11417 will also start
within the year.

If you want to judge the development of a company in the next decade, you need to pay attention to preclinical projects
.
From the perspective of the two ways of building the pipeline, Baekje has built a preclinical research team of more than 800 people within baekje, which has become the company's power engine for the next decade, and this team can be regarded as a huge
scale in the global view.
At present, there are more than 50 preclinical research projects in its pipeline, and nearly half of the drugs have the potential
to be "first-in-class" or "best-in-class".

In summary, Baekje's achievements at this stage have initially verified its ability to scale commercialization, and also confirmed its strong research and development and clinical strength
around the world.
With the potential of blockbuster varieties such as terelizumab and zebutinib gradually being released, the forward-looking nature of Baekje's business model is being verified, which also brings more confidence and strategic reference
to the industry.