CAR-T is a new type of precision targeted therapy for the treatment of tumors, which has been developed very hotly
both overseas and domestically in recent years.
In China, according to statistics, the number of CAR-T clinical trials has exceeded 500.
With the layout of domestic CAR-T enterprises in full swing, new breakthroughs and new progress are continuing
.
Recently, Yimiao Shenzhou announced the completion of hundreds of millions of yuan in Series D+ strategic financing, which will be used to support the new drug application application of IM19, the company's first CAR-T cell therapy product with independent intellectual property rights, to accelerate the commercialization process and provide new treatment options
for the majority of patients.
At the same time, we will continue to explore scientific, practical and low-cost gene cell drug technology, and strive to develop and produce more new and good anti-cancer
drugs.
At the upcoming 64th ASH Annual Meeting, Heyuan Biotech will release for the first time a number of CAR-T product R&D progress data results globally, including the company's first CAR-T drug Herquilenxel injection for the treatment of adult r/r B-ALL key clinical research data, which shows excellent data to bring patients high response rate, sustained remission and long-term survival benefits
.
According to reports, Hekilenxel is the first CAR-T product in the field of leukemia in China to reach the main clinical research endpoint, and it is expected to provide effective treatment for
adult r/r B-ALL patients after marketing.
On October 24, according to the Drug Review Center of the State Food and Drug Administration, Fosun Kite submitted an application for the registration of drugs for new second-line indications of Yikaida and was accepted and included in the list of
priority review varieties.
This means that adult patients with large B-cell lymphoma who do not respond to first-line immunochemotherapy or who relapse within 12 months of first-line immunochemotherapy can expect to benefit
earlier.
On October 18, CARsgen announced that the new drug application submitted by its CAR-T therapy Zevokiolensel injection has been accepted by the State Food and Drug Administration for the treatment of relapsed/refractory multiple myeloma
.
In early November, the Company announced that the abstract of Zervoki Olencel Injection has been accepted at the upcoming 2022 American Society of Hematology ("ASH") Annual Meeting and will be presented in poster form
to announce the progress of the research.
The product is a fully human anti-autologous BCMA CAR-T cell candidate for the treatment of relapsed/refractory multiple myeloma
.
In addition, on the same 18th, the Shanghai Stock Exchange showed that the IPO application of Hengrun Dasheng Science and Technology Innovation Board has been accepted, and it is expected to become the first CAR-T cell therapy company
in China to rush to IPO on the Science and Technology Innovation Board.
It can be seen that domestic CAR-T cell therapy is developing rapidly, constantly breaking through, exploring new progress, and has shown a trend
of "corner overtaking".
According to Frost & Sullivan's forecast, China's CAR-T market size will be about 200 million yuan in 2021, and it is expected to grow to 5.
3 billion yuan by 2024, and the market size is expected to reach 28.
9 billion yuan by 2030, with a broad
market space in the future.
It is worth mentioning that although domestic CAR-T products have made continuous progress in commercialization and internationalization, there are still some challenges to be dealt with
from large-scale application.
For example, the current research field of CAR-T therapy is mainly focused on hematological tumors, according to Caitong Securities Research Report, most of the CAR-T clinical trials currently carried out worldwide are for hematological tumors
.
However, more cancer cases worldwide are solid tumors, but aspects such as the immunosuppressive microenvironment are challenges
.
In this regard, the industry believes that if CAR-T can make a breakthrough in solid tumors, its commercial value will be greatly improved
.
At the same time, CAR-T therapy also faces high production costs, resulting in high prices and heavy patient costs
.
According to the data of Industrial Securities Research Report, the cost of preparing a CAR-T cell is about 200,000-500,000 yuan, and the corresponding CAR-T product is often one million yuan
.
Some people in the industry believe that allogeneic CAR-T products have the possibility of large-scale production, or achieve large-scale and greatly reduce the cost of CAR-T production, and have greater commercial prospects
.
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