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ADC is not a new concept, Pfizer launched the world's first ADC drug Mylotarg
as early as 2000.
But in the nearly 20 years since then, ADC drugs have failed to usher in a new era
because of safety or efficacy issues.
Until 2019, the DS8201 was born
.
In the clinic, DS8201 has demonstrated a disruptive effect on existing therapies, refreshing people's expectations
for HER2 ADC drugs and even the entire ADC track time and time again.
For a time, ADC drugs have become a fragrant food sought after by everyone
.
Not only overseas pharmaceutical companies have benefited, but domestic pharmaceutical companies are also on the wind: the introduction of Ambrx's HER2 ADC drug ARX788 new code biology, in the capital winter to complete the high valuation financing
.
Entrepreneurs dream of becoming the next DS8201, and investors are eager to invest in the next DS8201
.
However, sorrow and joy always come with it
.
For now, things seem to be moving
in the opposite direction.
The powerful performance of DS8201 has boosted the popularity of the ADC track and successfully promoted the development of the entire industry.
But for some latecomers, the DS8201 may be an
insurmountable barrier.
This also leads to HER2 ADC vents, but the future does not belong to them
.
This will be true
not only in the ADC space, but in the entire HER2-targeted drug market.
The knockout tournament has begun
.
/ 01 /
/ 01 /Potential players who abandon the ADC pipeline
Potential players who abandon the ADC pipeline Once upon a time, Ambrx was one of
the hottest potential players in the HER2 ADC space.
Ambrx's HER2 ADC drug ARX788, the clinical target is the second-generation ADC drug TDM-1, and the data is very good
.
According to the phase I clinical data in China led by Xinma Biologics, a subsidiary of Zhejiang Pharmaceutical, a partner of Ambrx, ARX788 has an objective response rate of 66%
in patients who are resistant or refractory to previous HER2 treatment.
It remains effective for patients who fail HER2 ADC therapy (T-DM1, etc.
) and has an objective response rate of 80%.
If this data continues to be maintained in subsequent clinical trials, ARX788 can still have good room for
development.
With this, Xincode Bio completed the counterattack and raised a high valuation in the capital winter, and the valuation far exceeded that of Ambrx
.
"There must be one that is wrong: the same pipeline, domestic biotech valuation = 4 US stock companies"
However, the rise of the DS8201 is a great challenge
for the ARX788.
DS8201 is too against the sky, has successfully defeated TDM-1, becoming the first choice
for second-line breast cancer treatment in Europe and the United States.
As a result, Ambrx quickly adjusted its clinical plan overseas and began to study the effects of
ARX788 in breast cancer patients who failed DS8201 treatment.
But now it seems that Ambrx has given up on the struggle
.
On October 19, Ambrx announced that it would no longer advance the clinical development of ARX788 for the following reasons: the HER2 competitive landscape has changed
.
However, Ambrx did not abandon the ADC market, saying that it will develop PSMA ADC - a potential player
with the potential to become a first-in-class drug.
To put it bluntly, it is easy to score from 70 to 90 points on a test paper, but it is not so simple to go from 90 to full
scores.
Instead of being a scumbag in the track full of top students, it is better to go to other markets with unmet clinical needs to be a top
student.
Ambrx's choice will undoubtedly transmit the cold to other HER2 ADC players, such as Xincode Bio,
which has previously completed high-valuation financing with this product.
/ 02 /
/ 02 /HER2 bispecific antibodies that start to drop in price
HER2 bispecific antibodies that start to drop in price DS8201 continues to push boundaries, not only as a one-man success, but also as a milestone in
HER2 target development.
With DS8201 in front, even latecomers to non-ADC products on HER2 targets are steeply more
difficult to break through.
No, under the overhead view of the DS8201, HER2 bispecific antibodies began to "drop price"
.
On October 19, Jazz Pharmaceuticals announced a cooperation agreement with Zymeworks to introduce the latter's HER2 bispecific antibody Zanidatamab global rights (excluding some Asian countries such as China).
In a way, the down payment is a "touchstone"
for a BD transaction.
According to the terms, the transaction price can reach up to $1.
76 billion, but the down payment is actually only $50 million
.
In contrast, domestic pharmaceutical companies have previously introduced the commercialization rights of Zanidatamab, including China and other Asian countries, and the down payment of the transaction is: 40 million US dollars
.
On one side are developed markets such as Europe and the United States, and on the other hand, developing markets such as China, the corresponding down payments in the two markets are close, which is enough to prove that the market's expectations for Zanidatamab have become lower
.
Zanidatamab has innovated to simultaneously target two different epitopes of subunit 2 and subunit 4 in the extracellular region of HER2, potentially leading to better therapeutic outcomes
.
However, due to the lack of much clinical data, whether it can be "synergized" or blind box
.
For now, at least, there is some concern
.
Not long ago, Zymeworks announced a Zanidatamab-based bispecific antibody ADC, and the clinical data could not bear to look at
it directly.
Behind the $3.
6 billion biotech fall: Innovation requires 'idealism', but investment is not.
Against this backdrop, Zanidatamab seems understandable for cutting prices
.
However, the cold brought by Zanidatamab is also destined to affect more people
.
At present, only in China, there are many biotechs such as Corning Jerry and Tianguangshi developing HER2 biantibodies
.
The challenge Zanidatamab faces is one that everyone needs to solve
.
/ 03 /
/ 03 /Competitive revelations from HER2 targets
Competitive revelations from HER2 targets In the field of biomedicine, people are looking forward to the emergence
of "role models".
Because only when the "role model" becomes bigger and stronger, so that investors' expectations become reality, many players in this market have more opportunities to win the favor of capital, and finally have the possibility
of standing out.
Indeed, the ADC track has been booming
in recent years thanks to the DS8201.
Since the First Three Kyos detonated the market, ADC has instantly become the Jerusalem in the hearts of pharmaceutical companies, and pilgrims have flocked to
it.
"ADC trading price quadruples in 4 years: the more big pharma rolls, the more biotech gets high"
However, the problem that comes with it is that when the wind comes, it does not necessarily lead to a situation of prosperity, but "winner takes all", making the living space of other players more pressed
.
Of course, the DS8201's menacing does not mean that other players have no chance
at the HER 2 target.
As long as it has better safety, or develops a pricing system that is suitable for suitable indications and more suitable for local conditions.
.
.
On the track where the bucks are chasing, there is still a lot to be done
for the strong players.
"Against DS8201, the winning method of domestic ADC players"
But in general, the difficulty of breaking through at HER2 targets has increased
significantly.
After all, the DS8201 is
too strong.
Therefore, the HER2 track occupied by DS8201 will eventually usher in a wave of "clearance" process
.
The situation of Ambrx and Zymeworks today is undoubtedly officially announced: the HER 2 target has begun to be eliminated
.
This situation is not only in the HER 2 target, but also in other innovative drug fields
.
To put it bluntly, the rivers and lakes of medicine, there is nothing hello I am hello
everyone.
It's always been like, "I'm good, you're not.
"
