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In just one year, EQRx, which intends to subvert the rules of innovative drugs in the United States, returned to the real world
.
EQRx, an American biopharmaceutical company established in 2020, aims at the demand behind the high prices of innovative drugs in the United States, intending to subvert the American innovative drug industry
with low-cost Me too drugs.
EQRx's business idea was once recognized by Wall Street, so much so that EQRx was able to attract more than $2.
5 billion and become a super unicorn in a year and a half after its establishment
.
However, the buzz comes and goes quickly
.
The product is not yet on the market, and EQRx's low-cost Me too drug strategy has failed
.
In the third quarterly report of this year, EQRx disclosed that it had abandoned the PD-L1 listing plan in the United States while announcing that it had abandoned the "low price" strategy
.
EQRx's decision was prompted by the fact that the FDA's approval of Me too drugs has become stricter, and there are no shortcuts
.
This leads to, Me
The dividend period of too drugs has been drastically curtailed
.
Based on this, EQRx's ideal business empire almost collapsed
.
The setback of EQRx also reminds us that being able to provide low-cost drugs is the value of being a pharmaceutical company; But what can prove the value of an innovative pharmaceutical company should not only be low price
.
/ 01 /
/ 01 /FDA says no to the "price butcher.
"
"
Where are the highest prices of innovative drugs in the world? There is no doubt about the United States
.
Taking PD-(L)1 as an example, the annual cost of treatment in China is about 30,000-50,000 yuan, while the United States is basically about
150,000 US dollars.
Note that the latter is in US dollars
.
The American government has suffered sky-high drugs for a long time
.
After seeing this situation, Alexis, who has a continuous successful entrepreneurial experience in biotechnology
Borisy couldn't sit still
.
He said he saw a huge opportunity to become a disruptor by providing high-quality drugs at very low prices
.
How low is the price? Alexis
Borisy said that if the cost of traditional treatment is $200,000, he hopes to provide the same drug
for $70,000 or even $50,000.
Based on this vision, EQRx was born in January 2020
.
According to Alexis Borisy's vision, EQRx's business logic is to bring in high-quality Me from around the world
Too drugs, and then approved before the expiration of the original drug patent and the subsequent marketing of the new mechanism drug, relying on the low price advantage to compete for the share
of the original drug.
of the original drug.
Soon, EQRx introduced blockbuster tumor drug categories such as PD-L1 antibodies, third-generation EGFR-TKI, and CDK4/6 inhibitors, hoping to show their talents
.
Unfortunately, the plans did not catch up with the changes
.
On November 10, 2022, EQRx announced in its third quarterly report that it will abandon the marketing application
for the PD-L1 drug sugemalimab non-small cell lung fourth-line therapy.
The reason is that the rules of the American world of innovative drugs have changed
.
changed.
In the past year, the FDA has continuously tightened the concept of
innovative drug review.
According to the FDA's current requirements, an innovative drug can only be approved for marketing
if the effect is not inferior to standard therapy.
Currently, the standard treatment for non-small cell lung cancer in the United States is the K drug
.
Therefore, the basis for EQRx's sugemalimab approval for marketing is head-to-head clinical
trials with K drugs.
Embarrassingly, when EQRx introduced sugemalimab, the standard of treatment for this indication was chemotherapy
.
Therefore, EQRx was carrying out clinical control group therapy at that time, which was also chemotherapy
.
Now, in response to FDA review rules, EQRx needs to change its clinical protocol and conduct another head-to-head clinical trial
with K drugs.
That's for EQRx, Alexander
.
On the one hand, head-to-head trials require huge additional R&D investment; Head-to-head trials, on the other hand, consume not only money, but also time
.
.
Time-consuming, labor-intensive and uncertain, EQRx eventually abandoned the sugemalimab pipeline after weighing the pros and cons
.
/ 02 /
/ 02 /Abandon the low-price strategy and return to reality
Abandon the low-price strategy and return to realityWhile abandoning the sugemalimab pipeline, EQRx also abandoned the low-price strategy
.
At present, EQRx also has two core pipelines, namely the third-generation EGFR TKI aumolertinib and the CDK4/6 inhibitor Lerociclib
.
Both products have Me better potential, so EQRx will continue to work
clinically.
However, EQRx will promote the commercialization of both products with a normal pricing strategy
.
EQRx CEO Melanie Nallicheri bluntly said on the third-quarter earnings call that the shift in regulatory requirements has made me cheap
The Too strategy is no longer viable
in the United States.
in the United States.
Understandable
.
As mentioned above, the core of the "Me-too" gameplay is to play a time difference, and it is extremely important
to grasp the time window.
But as regulation tightens, there is little
left for the dividend period of "me-too" drugs.
for the grasp of the time window.
But as regulation tightens, there is little
left for the dividend period of "me-too" drugs.
Based on previous assumptions, EQRx expected aumolertinib to be able to accelerate approval and listing through Phase III clinical interim data, but now there is no hope, and the final listing node may not be until 2027
.
At that time, the competition of the third generation of EGFR-TKI will be more severe, and it is pointless
to compete for the market through low-price strategies.
As a result, EQRx returned to reality and no longer wanted to be a price butcher, but danced
with large and small pharmaceutical companies.
Although EQRx has not completely abandoned the low-price strategy
.
Outside the U.
S.
, EQRx is expected to stick to its low-price plans
.
EQRx, for example, filed aumolertinib in the UK
and plans to continue to apply the low price strategy
.
But the problem is that the United States is where
price butchers are most needed.
Investors were previously bullish on EQRx because of its potential
in the U.
S.
market.
Nowadays, whether it is the US market or the low-price strategy, EQRx has not been able to grasp it
.
After the halo faded, EQRx became an ordinary pharmaceutical company, without superior innovation ability, without a good product, and no longer attractive
.
On November 10, EQRx's stock price fell 28.
62%
after announcing the abandonment of its low-price me too drug strategy.
Today, EQRx's market capitalization is just $1.
8 billion, a $2.
4 billion drop from its peak.
EQRx sank
with its dream of changing the U.
S.
biopharmaceutical industry.
/ 03 /
/ 03 /Innovation is the eternal nirvana
Innovation is the eternal nirvanaFor the failure of EQRx, many people already have a hunch, because the FDA has long foreshadowed the tightening of Me too drugs
.
Although in 2019, Dr.
Richard Pazdur, director of the FDA's Oncology Center of Excellence, welcomed China's "catfish" to the United States, putting price pressure
on PD-1 in the United States.
But since last December, Dr.
Richard Pazdur's style has changed and he has published an article attacking the PD-1 track me too drug clustering
.
In February this year, Eli Lilly introduced Innovent Biologics' PD-1, but because it did not meet the approval requirements clinically, it encountered obstacles to access
.
We can all see that the FDA no longer welcomes
overly repetitive Me too.
In the eyes of the FDA, the key to evaluating whether a drug can be approved for marketing is the effect
.
As for the price of the drug, it is at best the icing on the cake
.
As long as the effect is good enough, the price can be ignored
.
After all, the FDA's job is not to control the price of drugs, but to be the gatekeeper of the
US innovative drug market.
The collapse of the EQRx low-cost Me too model is not without reference significance for domestic enterprises
.
On the one hand, for enterprises wishing to go overseas, they will also face problems like EQRx; On the other hand, CDE's drug review standards are becoming stricter and are increasingly internationalizing to align
with the FDA.
In this context, those pharmaceutical companies that want to rely on low prices to win undoubtedly need to think about how long
the killer tool of low prices can be used.
In the final analysis, whether in the United States or in China, the real competitiveness of innovative pharmaceutical companies should not only be price, only innovation is an eternal nirvana
.
