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Domestic innovative drug companies are keen to develop ADC drugs, and their hidden risks have not yet been fully revealed
.
On October 18, Ambrx Biopharma, a US biopharmaceutical company that mainly researches next-generation ADC products, announced that it will suspend the internal research and development
of its core product ADC drugs.
Ambrx has been developing this ADC drug for at least 5 years, and it is a little famous
in the industry.
More importantly, a domestic innovative pharmaceutical company also introduced this drug
.
In July this year, Zhejiang Pharmaceutical, which is mainly engaged in APIs and intermediates, issued an announcement that its subsidiary Xinma Biotech completed the B round of financing, and after this financing, the valuation of Xinma Biotech reached more than
3 billion yuan.
In the "innovative drug winter" that the outside world believes, it is not easy for Xinma Bio to get B round of financing, mainly because XinmaBio has two ADC drugs: ARX788 and ARX305, both introduced from Ambrx
.
Now that Ambrx has announced that it is suspending ARX788, where does the new code creature go?
When the cold is passed to the ADC
When the cold is passed to the ADC Founded in 2003, Ambrx has many years of R&D experience in the vertical field of ADC, and has received a lot of capital attention, especially the preference
of well-known domestic investment institutions.
According to Artery.
com, in 2016, China Everbright and Sinopharm participated in the financing
of the company.
ADC products are composed of three parts: monoclonal antibody, small molecule toxin and linker, which can ideally reach the therapeutic target stably and accurately, and can release cytotoxins near cancer cells for treatment, with broad
application prospects.
Ambrx's products under development have been recognized
by many Chinese pharmaceutical companies.
In addition to XinmaBio, China Biopharma and BeiGene have introduced products
from Ambrx.
No one thought that Ambrx would have a day of surviving with a broken arm, especially in the ADC area it excels at
.
According to Ambrx, the company will suspend the internal development of ARX788 and will actively seek partners
outside the Chinese market.
Because the rights and interests in the Chinese market have been sold to XinmaBio, in May 2021, China CDE also included ARX788 in the list of breakthrough therapy drugs for the treatment of HER2-positive advanced breast cancer
.
New Code Bio is not blindly license-in
.
ARX788 received Fast Track designation from the FDA for HER2-positive breast cancer in January 2021; In March of that year, it was granted orphan drug designation by the FDA for the treatment of HER2-positive gastric cancer and gastroesophageal junction cancer
.
It can be seen that this is a very promising ADC drug, and for HER2-positive breast cancer and gastric cancer, the introduction of this drug by Xinma Bio is definitely to give itself a long face
.
Competitors came too quickly
.
In September 2021, shortly after ARX788 obtained a series of green channels, at the plenary meeting of the European Society of Oncology, the ADC drug DS-8201 jointly developed by AstraZeneca and Daiichi Sankyo attracted industry attention: in the treatment of HER2-positive breast cancer patients, this drug is better than Roche's ADC enmetrastuzumab
.
In the middle of this year, at the American Society of Clinical Oncology, DS-8201 again attracted attention
with excellent clinical results.
On the other hand, ARX788, in the two years after entering multiple green channels, has still failed to make a breakthrough on the market, and it is obviously difficult to catch up with DS-8201
.
In April this year, the China Food and Drug Administration granted DS-8201 breakthrough therapy designation for the treatment of unresectable or metastatic HER2-positive breast cancer; In August, the FDA officially approved it to treat metastatic or unresectable non-small cell lung cancer
with HER2 mutations.
This has made countless ADC players focused on HER2 targets anxious
.
In particular, at a time when the overall global pharmaceutical environment is cold and the competitive pressure in the ADC field is increasing, the veteran ADC Ambrx also needs to think about dislocation competition
.
In the announcement, Ambrx said that due to changes in the HER2 competitive landscape, the company has decided to tentatively involve the internal development of
the ARX788.
East Asia Qianhai Securities commented that Ambrx had to abandon the pipeline
in the face of the DS-8201's attack.
At present, whether it is global or Chinese, there are indications and targets in the entire ADC field, and HER2 targets have become the focus
.
Only true innovation can lead to a way out, otherwise it is likely to usher in a return on investment
.
One will be successful
One will be successful According to Huaan Securities, as of June this year, there are 471 ADC clinical development projects in the world, which are mainly aimed at HER2, EGFR, TROP2 and CLDN18.
2 four major targets, of which HER2 targets are developed far more than other targets
.
2
After suspending the ARX788, Ambrx said the company has positioned its R&D focus on the ARX517 because "it has the potential to become the first prostate-specific membrane antigen (PSMA)-targeted ADC
.
"
In addition to optimizing the pipeline, Ambrx has also been unable to escape layoffs
.
According to its official website, the company will reduce its staff by about 15%, while actively hiring new CEOs to help the company out of trouble
.
While the industry is saddened by Ambrx, another veteran of innovative drugs is also feeling pressure
on the industry to "sell cheaply" its key products.
On October 19, Zymeworks, an American pharmaceutical company, announced that it will license its ZW25 product ZW25 to Jazz Pharmaceuticals
in major markets such as the United States, Europe, and Japan.
ZW25 is a HER2-targeting bispecific antibody that was previously favored
by the industry.
Under the agreement, Jazz is required to pay an upfront payment of $50 million, plus all subsequent milestone payments, for a total of up to $1.
76 billion
.
BeiGene partnered with the Zymeworks company in November 2018 to obtain ZW25 and ZW49 cooperation in the Asia-Pacific region excluding Japan
.
At that time, BeiGene had an down payment of $40 million, and a milestone payment
of up to $390 million.
According to the capacity comparison of the Asia-Pacific market and the European and American markets, the industry believes that Zymeworks licenses two ADC drugs at a total cost of $1.
76 billion, which is equivalent to "cheap sale"
.
The reason for the rush to sell two drugs is none other than the surprise
of the DS-8201.
Many industry insiders said that as a bispecific antibody targeting HER2, breast cancer is undoubtedly the preferred indication for
ZW25.
But the presence of DS-8201 forced ZW25 to turn to cholangiocarcinoma, gastroesophageal cancer and other fields
.
In the ADC field, there may be a situation like K drugs, and many innovative pharmaceutical companies will make strategic adjustments
because of DS-8201.
