50+ enterprises have entered the market, and the "national" ADC era has been opened in China

The biopharmaceutical sector is still in the cold winter, and the industry is in mourning

In the past two years, because the first and third total HER2 ADCs have continued to break through history, they have detonated the sensitive nerves

In addition to Hengrui Pharmaceutical, Rongchang Biology, Kelun Pharmaceutical and other companies with earlier layouts, more Biopharma is keeping up, including Cinda Biologics announced this year: entering the ADC

Even more enthusiastic is Biotech

Obviously, whether it is a big pharmaceutical company with a head and a face, or a small pharmaceutical company that is precarious and unknown, there is an agreement on the development of ADCs

Behind this consistency, it must stem from the recognition of ADC technology and the expectation

So the question is, can the ADC track meet the dreams of many pharmaceutical companies?

/ 01 /

More than 50 entrants,

The era of national ADC has begun

How to describe the ADC track is hot?

Probably only the number of entrants can

Traditional pharmaceutical companies have a lot of interest, including CSPC Pharmaceutical Group, Kelun Pharmaceutical, Qilu Pharmaceutical, Huadong Pharmaceutical and other traditional pharmaceutical companies have performed positively and have long laid out

However, in contrast, it is the new generation of innovative pharmaceutical companies that have performed more positively

In July this year, Innovent Bio registered the phase I clinical trial of the ADC drug IBI343 on the clinical trial

Since the beginning of this year, it also includes a number of innovative pharmaceutical companies such as Yingen Biology, Baili Pharmaceutical, Corning Jereh, Yilian Biologics, etc.

Although many pharmaceutical companies have not yet entered the clinical stage of their products, they are also saying: We are developing ADCs!

For example, Jia Coase, which is committed to the development of non-druggable targets, said in the semi-annual report that it has laid out the subdivision of the ADC iADC

The so-called iADC is to change the toxin in the structure of the ADC into an immunostimulant, which can theoretically cope with the toxicity problems of traditional ADCs and the challenge of

Obviously, Jiakesi, which does not have an advantage in the research and development schedule, has chosen a path

Fuhong Henlin, who has thick eyebrows and big eyes, has also "rebelled

Pharmaceutical companies that have not yet been able to incorporate ADC into the pipeline plan are also planning to cut into the track

It can be said that Biotech's desire for ADC is serious
.

/ 02 /

Behind the R&D hot land:

Overtaking in curves is possible

So the question is, there are many entrants, will ADC stage a PD-1 tragedy? In a way, not exactly
.

The reason is that PD-1 belongs to homogeneous competition, and there is no advantage in production capacity and dosage form, and it is difficult to extend more differentiated competition
.

But ADCs are different
.
ADC is a cross-combination of antibody + linker + toxin three parts, all three parts can be replaced, and the number of drug candidates has increased exponentially
.

For example, pharmaceutical companies can develop different products by replacing ADC targets
.

Most of the original ADCs focused on blood tumors, which also limited the ADC's imagination
space.
However, with the technical update iteration of T-DM1 and DS-8201 and the replacement of targets, ADC indications have been opened up to the field of solid tumors
.

Whether it is a blood tumor or a solid tumor, there is still a lot of room
for exploration.
The DS-8201, which is in full swing, only blocks the imagination space
of the HER2 ADC.

Many pharmaceutical companies also have other targets to choose from, such as FRα, B7-H3, ROR1, EGFR targets, etc
.
At present, the ADCs corresponding to these targets have not yet been drugged
.

Even at the same target, ADC drugs have room to
compete.
For example, indication differentiation, or directly start the product upgrade war
.
Any drug has drawbacks, even the DS-8201
.

DS-8201 Is the most criticized safety: DS-8201 has been found to cause interstitial pneumonia in many indications, which is fatal, so it was warned
by the FDA black box.

Obviously, this is the opportunity to
break through.
If side effects can be reduced while maintaining efficacy, there is still a chance
for HER2 ADC latecomers.
It can be said that challenging the DS-8201 is not impossible, but it is more
difficult.

But in any case, back to the entire ADC field, volume to volume, but also do not have to be too pessimistic, because the ADC road is wide
enough.

/ 03 /

More testing tracks:

Be wary of "investor relations management" R&D

But then again
.
The ADC is very different from the PD-1 and has the possibility of overtaking in curves, but the threshold for research and development is also higher
.

Because the ADC is a complex structure composed of three parts: monoclonal antibody, toxin, and connecting agent, the three are not simply uplifted and then added, but a balance point
is chosen.

How complex is that? For example, even copying is not guaranteed to be successful
.
The most typical is that the domestic players who have previously referred to TDM-1 have made me-worse products, and finally endured the loss
.

Even the latest generation of ADC drugs using site-specific coupling technology does not guarantee that products with good efficacy can be developed, such as SGN-CD33A developed by Genentech and MEDI4276 developed by AstraZeneca, all of which are folded due to all-round problems
.

Therefore, the final situation in the era of national ADC may be: thunder and rain
.
Although there are many entrants, there may not be too many
who can really push the product to the market.

What's more, many pharmaceutical companies themselves do not hope to attack the ADC field, but only hope to let the outside world see: they seem to be trying
.

Of course, after the baptism of recent years, the domestic innovative drug ecology has undergone qualitative changes
.
Most innovative pharmaceutical companies enter the ADC research and development, which must be with the purpose of breaking through the limitations of existing products
.

Under the national ADC, we may soon see that domestic pharmaceutical companies make better innovative products to meet the unmet clinical needs
.