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2022, Survival Atlas of PD-(L)1 in China

 Last Update: 2022-12-30
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The capital is not high and cold, but it is not you
who is "warm".

Last week, Akeso announced its partnership with Summit Therapeutics partnered to grant the latter an exclusive license to develop and commercialize Evosi's (PD-1/VEGF bispecific antibody) in the United States, Canada, Europe and Japan
.

Evoxi (PD-1/VEGF bispecific antibody) is a self-developed product of Akeso, with an authorized down payment of up to $500 million and an overall transaction amount of up to $5 billion
.
Not only set a license for China's innovative drugs The new OUT amount is also the second highest amount of authorized transactions for innovative drugs in the world in the past two years
.
*First: On December 14, Takeda acquired Nimbus for more than $6 billion Therapeutics psoriasis TYK2 inhibitor
.

Up to now, 10 PD-(L)1 monoclonal antibody products and 1 PD-(L)1 bispecific antibody product have been approved for marketing
by Chinese pharmaceutical companies.

Is the Chinese PD-(L)1 really the Red Sea? Looking back one by one from the performance, going to sea, and capital market, in 2022, we have seen the two heavens
of ice and fire.

01 "Innovative PD-(L)1" is still a blue ocean

"Innovative PD-(L)1" is still a blue ocean PD-(L)1"

The 2022 "Akeso License out" tells us that it is not PD-(L)1 that entered the Red Sea, but the world's "love-hate distinction"
after the bubble was broken.

What is clear is that me-too's low-quality innovation doesn't work
.

▲Innovation is not the blind pursuit of "first-of-its-kind"
.
Because innovative technology can only better exert business value
if it finds application scenarios with pain points and a market with scale at the right node.

In order to prove product quality, "head-to-head testing" is the most recognized method
worldwide.

"Head-to-head testing"

Refresh the license this time Out records that Akeso's Ewoxi (PD-1/VEGF bispecific antibody) is a domestic PD-(L)1 product that is undergoing "head-to-head trials", and the direct challenge is the "drug king" Merck's pembrolizumab (K drug).

Ewosi (PD-1/VEGF bispecific antibody)

Evesi and K monotherapy for the treatment of positive non-small cell lung cancer in a head-to-head trial with 388 participants
was planned.

Evesi is also the second "first-of-its-kind" PD-(L)1 bispecific antibody product of Akeso, which is currently in clinical phase
III.
The first is Kaitanil (PD-1/CTLA-4 dual antibody),
which was launched in China in June.

Kaitanil (PD-1/CTLA-4 biantibody)

Dietanib is used in second/third line therapy for relapsed or metastatic cervical cancer;

On the basis of the feasibility of PD-1+CTLA-4 combination, the ORR of ITT population is as high as 33%, the ORR of PD-L1 positive population is as high as 43.
8%, and the mOS is 17.
5m, and the efficacy is better than that of "PD-1+CTLA-4" combination
.

Multi-specific drugs, usually based on the design of classical drugs, add another layer of efficacy, forming multiple drug-target interfaces, thereby breaking through the limitations of a single target horizontally, which is equivalent to a set of "combination punches"
.
The industry believes that multispecific drugs will become the four transformative waves
of the modern pharmaceutical industry.

From the very beginning, Akeso has opened up a different way to focus on difficult multi-specific antibody drugs in the popular track of PD-(L)1, and almost all of its tumor products are "first-in-class" or "best-in-class" therapies
based on popular targets.

As the saying goes, monoclonal antibody looks at the target and dual antibody look at the platform
.

The reason why Akeso can "brush up the new price" comes from the self-developed bispecific antibody drug development platform (Tetrabody platform), which overcomes the three major CMC problems in the development and production of bispecific antibodies:

inefficient expression levels due to the high molecular weight of the bispecific antibody;

Process development obstacles caused by structural heterogeneity of bispecific antibodies;

Druggability
is affected due to the lack of stability of biantibodies.

At present, the domestic and foreign dual antibody market is still in the development period (big blue ocean) and growing rapidly, according to the Frost & Sullivan report, the size of the Chinese market will be about 200 million US dollars in 2023, and will increase to 10.
8 billion US dollars by 2030.

02 2022 domestic PD-(L)1 sales competition: Baekje or anti-Xinda surpassed, and the rising star has emerged

2022 domestic PD-(L)1 sales competition: Baekje or anti-Cinda, rising stars are beginning to emerge

With its foresight, Akeso has opened up the "second growth curve"
of the PD-(L)1 track.
In the field of traditional PD-(L)1 monoclonal antibodies, the "popular fried chicken" of the year is now struggling with cruel competition, crowded tracks, new and old faces on the same stage, and the increasingly complex competition factors, which will inevitably lead to seat turmoil and changes in the industry pattern
.

The first four major approved PD-(L)1 products now form the top echelon of the market, and in 2021:

Hengrui Pharmaceutical (carrelizumab) ranked first in sales of 4.
141 billion yuan;

Hengrui Pharmaceutical (carrelizumab)

Innovent (Cindilimab) ranked second with 2.
801 billion yuan;

Innovent (Cindilimab)

BeiGene (tislelizumab) ranked third with more than 1.
6 billion yuan;

BeiGene (tislelizumab)

Junshi Biologics (teripulimab) ranked fourth
with 412 million yuan.

Junshi Biologics (teripulimab)

However, this ranking will change
in 2022.

Based on the results of the first three quarters of 2022 (except for Hengrui Pharmaceutical's unannounced specific sales), BeiGene (tislelizumab) will surpass Innovent to rise to second
.

The first three quarters of 2022

Domestic PD-(L)1 TOP4 revenue comparison

Although the status of "domestic PD-(L)1 TOP4" is temporarily unshakable, the rising star has begun to appear
.

Akeso Biologics (Peamplimab), with sales of about 212 million yuan in the 3 months of listing in 2021, sales of about 300 million yuan in the first half of 2022, and annual sales or more than 500 million yuan, approaching the status of
Junshi Biologics.

Akeso (PEMPLIMAB)

In addition, Corning Jerry/Sidi/Simcere Pharmaceutical (Envolimab) has sales of about 160 million yuan
in the five months of its listing in 2022.
Henlius (serplulimab) has sales of approximately 77 million yuan
in the three months of its listing in 2022.

Corning Jerry/Sidi/Simcere Pharmaceuticals (Envolimab), Henlius (Serplulimab)

Although CStone Pharmaceuticals (sugemalimab) did not release specific data, CStone expects its peak domestic sales to exceed 1 billion yuan
.

CStone (sugemalimab)

The indication and medical insurance is PD-(L)1 The key dominant competitive factor
of the track.

Specific number of approved indications:

The number of approvals for an indication largely determines the market capacity
of this drug.
Taking the global "Prodrug King" Humira and "Current Drug King" K drugs as examples, more than 17 and 30 indications
have been approved respectively.

17 out of 30 items

At present, in China's PD-(L)1 market, Merck K drug has been approved for 10 indications, ranking first
.

BeiGene (tislelizumab) was approved for 9 indications, becoming the first in China;

BeiGene (tislelizumab) 9 items

Hengrui Pharmaceutical (carrelizumab) was approved for 8 indications, ranking second in China;

Hengrui Pharmaceutical (carrelizumab) 8 items

Innovent Biologics (Cindilimab) and Junshi Biologics (teripulimab) were approved for 6 indications and ranked third
in China.

Innovent (Cindilimab) and Junshi (teripulimab) 6 items

In addition, in terms of "exclusivity" of indications, about 50% of BeiGene (tislelizumab) was the first to be approved and about 25% was the second approved
.

Indications "Exclusivity"

In terms of indications "broad (large indications)",

Indications "Broad (large indications)"

Innovent (Cindilimab) includes two lung cancers, one liver cancer, and one gastric cancer;

BeiGene (tislelizumab) includes three lung cancers, one liver cancer;

Hengrui Pharma (carrelizumab) includes two lung cancers and one liver cancer;

Junshi Biologics (teripulimab) includes one count of lung cancer;

Specific number of indications:

Different from the world, in the Chinese market, entering medical insurance is an important way
to achieve rapid product volume.

As of 2022, only BeiGene (5 items), Hengrui Pharma (4 items), Innovent Biologics (4 items), and Junshi Biologics (3 items) were included in the medical insurance of PD-(L)
1.

5 items, 4 items, 4 items, 3 items

These companies have to bear the "risk"
of declining profits while gaining market increments.

In 2019, Innovent Biologics (Cindilimab) became the first PD-(L)1 product to enter medical insurance, with a price reduction of 64%; 2020 national talks, domestic PD-(L)1 All TOP4 entered medical insurance, with an average price reduction of more than
80%.

Price reduction of 64%, price reduction of more than 80%.

Taking carrelizumab as an example, the sales volume in 2021 was +361% year-on-year, but the "price reduction" also made Hengrui Pharmaceutical's anti-tumor business revenue in 2021 -14.
39%
year-on-year.

In 2022, 6 domestic PD-(L)1 monoclonal antibody products have passed the preliminary review list or will participate in national talks, among which:

6 models

2 models are the first to participate in the national talks: Henlius (serplulimab), Corning Jerry/Sidi/Simcere Pharmaceutical (Envolimab);

2 models

4 new indications were negotiated: Hengrui Pharmaceutical, BeiGene, Innovent Biologics, and Junshi Biologics, with a total of 12 new indications;

4 models

It is reported that Yuheng Biologics (sepalimab), Akeso (PEAMPLIMAB), and CStone (sugemalimab) will not participate in the 2022 medical insurance negotiations
at the end of the year.

03 2022 Domestic PD-(L)1 Overseas Competition: Junshi Biotech Becomes FDA "Unique Seedling" Overseas markets are no longer limited to the United States

2022 Domestic PD-(L)1 Overseas Competition: Junshi Biotech Becomes FDA "Unique Seedling" Overseas markets are no longer limited to the United States

On February 10, Innovent (Cindilimab) faced the FDA's Oncology Drug Advisory Committee (ODAC) for the first time, and finally temporarily stopped the FDA with a 14:1 vote; The reason for the rejection was mainly insufficient overseas clinical data
.

Innovent (Cindilimab)

This seems to have unveiled the "Pandora's box"
for domestic PD-(L)1 to go to sea in 2022.

On May 3, Junshi Biologics (teripulimab) was required by the FDA to make a quality control process change, and due to the epidemic, the review was delayed, after which Junshi resubmitted the final approval of the BLA and set for December 23 (next Friday).

Junshi Biologics (teripulimab)

In July, BeiGene (tislelizumab) delayed the on-site review by the FDA due to the epidemic, and the specific time was undecided
.

BeiGene (tislelizumab)

The most direct negative chain effect caused by this series of events is the "termination"
of overseas cooperation.

On December 2, Innovent said it had withdrawn its overseas rights
in Cindilimab from Eli Lilly.

In the third quarter of this year, CStone partner EQRx said that it will no longer seek marketing approval for sugemalimab in the United States (or transfer to markets outside the United States), and announced that it will abandon the "low price" strategy
.

Since then, Junshi Biologics (teripulimab) has become the 2022 US FDA's Chinese PD-(L)1 "unique seedling" (the last hope for China's PD-1 to go overseas in 2022), but given its limited overseas clinical data, success may not be likely
.

Although being "recognized" by the US FDA seems to have become an important criterion
for an innovative drug to emerge in the global market.
But more and more Chinese startups are realizing that going overseas is not limited to the U.
S.
market
.
For example, the market size is second only to the United States, and countries along the "Belt and Road
".

BeiGene's PD-1 tislelizumab, in addition to continuing to seek marketing in the United States, has accepted marketing applications in Europe, the United Kingdom, Australia and other places
.

Junshi PD-1 teripulimab two indications were also accepted
in Europe.

CStone Pharmaceuticals recently said that its sugemalimab is also about to submit its first marketing application
overseas.

As China's first innovative pharmaceutical company to successfully go overseas, BeiGene's experience in expanding the overseas commercialization of innovative drugs may provide some inspiration
.

Take the BTK inhibitor zebrutinib as an example:

First listed in the United States, open up overseas situation;

Secondly, new indications have been approved for continuous expansion, and the approved indications in the United States include mantle cell lymphoma (MCL), Fahrenhenic macroglobulinemia (WM) and marginal zone lymphoma (MZL);

Once again, the global expansion of commercialization has covered more than 50 countries and regions around the world, including the United States, China, the European Union, the United Kingdom, Canada, Australia, South Korea, Switzerland, etc.

In the first half of 2022, zebratinib's global sales were 1.
514 billion yuan (+262.
9%), of which the US market accounted for 67% (sales increased by 504.
5% year-on-year).

04 2022 domestic PD-(L)1 enterprise market value competition: 80% of enterprises market value has shrunk significantly

2022 domestic PD-(L)1 enterprise market value competition: 80% of enterprises market value has shrunk significantly

Chunjiang Plumbing Duck Prophet, the performance of all these products and the success of "going to sea" will become the measurement target
of secondary market investors.

From the beginning of 2022 to the present (as of the close of December 8), among the domestic PD-(L)1 companies, the overall stock price has risen only two: Lepu Biotech rose by 24.
5%, with a total market value of HK $14.
7 billion; Akeso rose 15.
3% to a total market value of HK$33.
2
billion.

Lepu Bio Akeso

Lepu Biotech's putelimab was just approved in July and has not yet been severely beaten
by the market.
After receiving good news from the $5 billion license out, Akeso's stock price almost rose to the limit
.

Akeso share price

Relying on these advantages, on December 6, Akeso announced that it will be listed on the Science and Technology Innovation Board for the second time
.

At present, innovative pharmaceutical companies listed on the STAR Board from Hong Kong stocks include: Junshi Biologics, BeiGene, Remegen Biologics, CanSino Biologics, and InnoCare
.

R&D needs to "burn money", and for these innovative pharmaceutical companies that are not yet profitable, financing strength is also "hard power"
.

A successful innovative drug "nine dead life", and innovation and commercialization can be both attained
.

China's PD-(L)1 market in 2023 may be a world
where the stronger is stronger.

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