"Keji Pharmaceutical" broke the market?

Image source: Oriental Fortune Network

More monks and less meat, the market competition is becoming more and more fierce

In 2020, the combined sales of Zolgensma and Kymriah, the world's leading gene therapy drugs, which are listed by Novartis, have reached US$1.
4 billion
.

In April 2021, a total of 12 gene therapy drugs will be marketed worldwide;

On January 12, 2021, Fosun Kate’s CAR-T therapy officially entered the stage of administrative approval.
It is the fastest-growing company in China and is expected to become the first in China
.

Behind the above is the competition situation of hundreds of pharmaceutical companies around the world, and the track is crowded, the targets are repeated, and the homogeneity of the products is particularly serious.
The probability of standing out is better than that of the eight-legged essay
.
In terms of the two major targets of BCMA and CPC3 alone, there are 4-8 domestic companies with the same layout as Keji Pharmaceuticals.
If the popular CD19/CD20 is added, the number of competing companies will exceed 20
.
And as the first CAR-T cell therapy targeting BCMA developed by Bristol-Myers Squibb (BMS) and its partner Bluebird Biology has also been launched, it is expected that some companies will enter the cake in the later period
.

For now, Keji Pharmaceutical's biggest domestic competitors should be Legend Bio, which was the first to be listed on the US stock market, and WuXi Junuo and Yongtai Biotechnology in the Hong Kong market
.
Among them, the LCAR-B38M/JNJ-68284528 jointly developed by Legend Biotech and Janssen has submitted the BLA to the US FDA, which is the fastest-growing similar product in China
.
After that, rivals such as WuXi Biologics, Yongtai Biologics, Yuanqi Biologics, and Yimiao Shenzhou are all eyeing each other.
Each company has its own unique core competitiveness.
It is conceivable that Keji Pharmaceutical wants to stand out from the crowd
.

However, Keji Pharmaceuticals also stated that the clinical data of the company’s key products are excellent, and it will submit a new drug application to the National Food and Drug Administration in the first half of 2022, and submit a BLA to the US FDA in the first half of 2023.
The progress should still be advanced
.

Price is still the biggest obstacle restricting the commercialization of CAR-T

Due to constraints such as complex manufacturing conditions for CAR-T therapy and high requirements for technicians, the current treatment costs are always high.
The wholesale prices of the four previously approved products are prohibitive enough.
The price of Breyanzi is US$410,300, Tecartus and Tecartus.
Yescarta prices are both US$373,000, and Kymriah prices are between US$373,000 and US$475,000
.

What is involved behind the price is the technical constraints of the autologous CAR-T therapy itself, which makes it costly in time and money to produce CAR-T cells each time and cannot be promoted on a large scale
.
Although there are domestic and foreign companies such as Keji Pharmaceutical, Hengrun Dasheng, Genxi Biological, Reindeer Medical, Boya Gene, Linglu Pharmaceutical and other domestic and foreign companies on the research progress of general-purpose CAR-T therapy
.

But at least, the current situation of CAR-T products that are continuously announced on the market still cannot be truly resolved.
The high price still greatly limits the possibility of large-scale commercialization.
It is expected that CAR-T treatment will continue to be used for a long time in the future.
Self-finance will be the main factor, which is even more severe for China, where commercial insurance is not common
.

Of course, it is not only in the field of CAR-T, but most of the cases in the field of cell therapy are like this, and the national conditions with Chinese characteristics also determine that there will be more obstacles to the development of cell therapy in China, and the subsequent sales growth rate will be much lower than that of the United States.
, The overall penetration rate will also be significantly lower than that of the United States
.

As far as Keji Pharmaceutical is concerned, if it takes the lead in the market with its leading clinical research, but hopes to include it in medical insurance and centralized procurement, it will be resigned
.
The pricing issue alone greatly offsets the advantages of new companies.
Is it to choose to be tough with large international companies? Or choose the price advantage in line with Chinese characteristics? They are all considered by the predecessors
.

to sum up

In general, although after the first two industrial changes in biomedicine, gene therapy is expected to lead the third industrial reform of biomedicine, it is also expected to become the most important pharmaceutical innovation direction in the next 20 years
.
Among them, the car-t treatment field is still in the early stages of development.
The more important role of companies such as Keji Pharmaceuticals as pioneers may be to lead the real arrival of "cancer treatment ushered in a new era of various CAR cells".
!

Editor in charge | Penicillin