Looking for PD-1 Blue Ocean Market Jianghu

After several years of hard work, from Biotech to Biopharma, it has become a new journey for many Chinese biopharmaceutical companies
.

Henlius, which has just announced its 2021 annual performance, will also start this new evolutionary process

As a pharmaceutical company that used to take biosimilar drugs first, in 2021, Henlius will officially transform to innovation
.

Its chairman, executive director and CEO Zhang Wenjie said at a recent media exchange meeting that the company's goal is not only biosimilars, but also hopes to enter the leading camp in the field of innovative drugs

Its first self-developed PD-1 monoclonal antibody, slulimumab (H drug), can it find a way of differentiation in the fierce competition of similar drugs?

time to innovate

time to innovate

"Innovation is a complex systematic project, which requires an organic combination of multiple departments, long-term and strategic advancement
.

At the same time, it is necessary to continue to survive the fittest, so as to achieve the goal of innovation and take into account innovation efficiency, and the latter is particularly important

He believes that the investment environment is becoming more and more severe, which is actually beneficial to the long-term development of the biopharmaceutical industry
.

Investment requires efficiency, and it needs to truly reflect the rate of return to investors

On this basis, Henlius has set the goal of transforming from Biotech to Biopharma in 2022
.

Transformation requires a clear enough understanding of the difference between the two

"For Henlius, there are both biosimilars and bio-innovative drugs, which is one of the characteristics
.

In addition, Biotech is a research and development company, while Biopharma has research and development, production, and commercialization.

According to the annual report, in 2021, Fuhong Henlius achieved an operating income of approximately RMB 1.
6825 billion, an increase of approximately 186.
3% over the same period last year.
Among them, the blockbuster product Hanquyou (trastuzumab, European trade name: Zercepac) achieved domestic The sales revenue is about 868.
0 million yuan, an increase of about 692.
7% over 2020, the overseas sales revenue is about 62.
2 million yuan, and the overseas licensing and R&D service revenue is about 30.
2 million yuan
.

It should be said that in the past year, Henlius' efforts in the commercialization of biosimilars have brought cash flow support to the company

Market Opportunities for PD-1 Products

Market Opportunities for PD-1 Products

According to the annual report, Henlius’ first self-developed innovative PD-1 monoclonal antibody, slulimumab (H drug), has two indications and is expected to be approved for marketing in 2022
.

The marketing registration application (NDA) of the first indication of H medicine for high microsatellite instability (MSI-H) solid tumors has been included in the priority approval process and is expected to be approved in the first half of 2022

In the red sea of ​​PD-1, does Henlius' H medicine have an advantage, and how to deal with the fierce market competition? Several company executives responded in interviews
.

"If you look at tumors as a single market, the competition for PD-1 products is indeed very fierce
.
But in fact, between tumors and tumors, between hematological tumors and solid tumors, from the perspective of mechanism, organs, histology and treatment methods, is it different? The same
.
Therefore, the differentiation of PD-1 products in different tumor types, different indications and different markets, the situation is not the same
.
” CEO Zhang Wenjie said
.

According to Zhang Wenjie, slulimumab is expected to be approved soon for the first indication for MSI-H solid tumors.
At present, the Chinese market is almost not fully developed, and there are about 300,000 new cases in China every year
.
This means that the product is still a blue ocean market for this indication, and it is not excessive involution
.

It is unavoidable that competitors for future commercialization of slulimumab have emerged
.
BeiGene's PD-1 tislelizumab has recently been approved for MSI-H indications
.

In this regard, Yu Cheng, Chief Commercial Officer of Henlius, said that there is no pressure: "On the one hand, from the perspective of the approval time, the two are basically on the same starting line, on the other hand, the market potential of MSI-H solid tumor is very great.
, is currently in an undeveloped stage.
If the two companies jointly develop and jointly promote the detection of MSI-H, improve the understanding of the disease by doctors and patients, and increase the awareness of the market, I think it will be a good thing.

We will even welcome more companies in the future to make this cake bigger together
.
"

At the same time, Yu Cheng also has confidence in the company's commercialization team
.
He believes that Hanquyou's sales performance proves the strength of its commercialization team
.
For PD-1 products, the company has also established a professional team to communicate and interact with doctors, and do a good job in doctor-patient education
.

It is reported that another indication of slulimumab, locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), has submitted an NDA application and was accepted in September last year
.

It is worth noting that non-small cell lung cancer is a highly competitive field, and multiple PD-1 products have layouts
.
The management of Henlius believes that even so, there are differences in clinical data between these products, and slulimumab is expected to have better performance in overall survival (OS) data, relying on clinical data to obtain competition for a place
.

Zhu Jun, President of Henlius, believes that although the company is in a latecomer position on the PD-1 track, the company has done a lot of market research and expert interviews.
These data also give H medicine great confidence in the field of lung cancer treatment
.
Especially in the field of small cell lung cancer, at present, only 2 PD-L1 products have been approved in the world, which has great market potential
.
Zhu Jun said that judging from the existing clinical data, slulimumab is expected to become the first domestic PD-1 product to obtain this indication
.

Zhu Jun further explained the existing clinical data: "Comparing slulimumab with PD-L1 products that have been approved for small cell lung cancer indications, our data advantages are also obvious
.
The current statistics show that two years The survival rate is 43.
2%, and the traditional treatment standard is 5% to 6%
.
However, public data shows that the two-year survival rate of IMpower133 (PD-L1 product registration trial) is 22% to 25%, so from the rigid two-year survival rate By metrics, slulimumab has doubled
.
"

In addition, slulimumab is also conducting clinical trials in the fields of digestive tract tumors, gastric adjuvant/neo-adjuvant, etc.
, which is expected to bring more differentiated advantages to the product
.

Competition and policy pressures for biosimilars

Competition and policy pressures for biosimilars

With the landing of the boots of the centralized procurement of biosimilars, the competitive landscape in this field has also undergone new changes
.
Judging from the data in the annual report, at present, biosimilars are undoubtedly an important pillar of Henlius
.
It is foreseeable that before other innovative drugs are launched, the two products, Rituximab (Hanlikang) and Hanquyou, are the main sources of revenue for the company
.
How will the centralized procurement of biosimilars carried out by the Guangdong Centralized Procurement Alliance have any impact on Henlius?

In this regard, the company's CEO Zhang Wenjie took the lead in giving the answer
.
He believes that in addition to the price reduction, capacity support is also a very important consideration for centralized procurement
.
During the commercialization process of Hanquyou in the past three years, it has mainly relied on the production capacity of 24,000 liters of Xuhui production base.
This year, the production capacity of 24,000 liters of Songjiang Base (1) is expected to realize production and release commercialization potential
.

Chief Commercial Officer Yu Cheng said that from the current trend, the centralized procurement of macromolecules is relatively mild, and the centralized procurement carried out in Guangdong Province this time is in line with expectations and will not have much impact
.
Henlius will also maintain its advantages in the field of biosimilars through a series of measures such as capacity expansion, process upgrade, and cost reduction
.