CAR-T therapy belongs to cell therapy, mainly through genetic engineering technology, artificially modify the T lymphocytes of tumor patients, generate tumor-specific CAR-T cells after a large number of cultures in vitro, and then inject them back into the patient's body to attack cancer cells, and then achieve the goal of
treating diseases.
It is reported that since the first CAR-T therapy was launched in 2017, 6 CD19 CAR-T and 2 BCMA CAR-T therapies have been approved worldwide, and the cumulative indications include acute lymphoblastic leukemia, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, sleeve cell lymphoma, follicular lymphoma and multiple myeloma
.
In China, there are also many pharmaceutical companies that have laid out the CAR-T field, and a number of products have been approved for listing
.
For example, on June 22, 2021, Fosun Kate CAR-T cell therapy agillonse injection was officially approved for the treatment
of adult relapsed refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) non-specific type, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and follicular lymphoma-transformed DLBCL 。 It is reported that the product is Fosun Kate's INTRODUCTION of HIT (Gilead Sciences) CAR-T product Yescarta® in the United States, and authorized for local production in China of the targeted CD19 autologous CAR-T cell therapy product
.
Fosun Kate said that the company will continue to make efforts
in the field of tumor immune cell therapy.
In June 2022, Icoida's ® clinical trial application (IND) for the second-line treatment of large B-cell lymphoma was accepted by NMPA
.
In addition to the expansion of more indications, Fosun Kate's second CAR-T cell therapy product, FKC889, for the treatment of adult patients with relapsed/refractory sleeve cell lymphoma (r/r MCL) after second-line or above treatment, was approved for clinical trials
in China in March 2022.
In addition, Fosun Kate is actively laying out R&D pipelines and strengthening its independent R&D capabilities, and is accelerating the promotion of 5 preclinical projects for solid tumors
.
On September 3, 2021, WuXi JunoCAR-T product Ricky Ollense Injection (trade name: Benodaz) was officially approved for relapsed or refractory large B-cell lymphoma (r/r LBCL)
in adult patients after second-line or higher systemic therapy.
Ricky Olensa Injection is a CAR-T product independently developed by WuXi Juno on the basis
of JCAR017 of Junuo Company.
It is reported that on July 4, 2022, WuXi Juno also announced that it has launched a Phase I clinical study
of its innovative cellular immunotherapy drug JWATM204.
JWATM204 is a T-cell immunotherapy that targets GPC3 for advanced hepatocellular carcinoma
.
This clinical study is also the first human clinical study of this treatment regimen, which means that WuXi Juno has taken an important step in the field of T cell therapy for the treatment of solid tumors
.
In addition to the above two products that have been approved in China, Legendary Biology under Kingsway Bio also has a CAR-T therapy, and at the end of February this year, Legendary Biology announced that the therapy was approved in the United States and is a domestic CAR-T cell therapy
approved by the FDA.
The industry pointed out that in the track of CAR-T therapy, in addition to the domestic CAR-T products that have been commercialized, many pharmaceutical companies such as Keji Pharmaceutical, Reindeer Biology, and Genxi Biology are also promoting CAR-T related research and development, such as Keji Pharmaceutical disclosed in the semi-annual report that CAR-T product CT053 plans to submit a new drug application to the State Drug Administration in the third quarter of 2022, and plans to submit a biopharmaceutical marketing authorization application to the US Food and Drug Administration in 2023
。
It is reported that at present, CAR-T treatment is still in the initial stage of development, and the future market space is vast
.
Some data predict that from 2021 to 2030, China's cell therapy market space will grow from 1.
3 billion yuan to 58.
4 billion yuan, with an average annual growth rate of 53%.
Among them, the market space of CAR-T cell therapy will grow from 300 million yuan in 2021 to 28.
8 billion yuan in 2030
.
However, at the same time, analysts also pointed out that there are still some important problems to be solved in CAR-T treatment, such as adverse reactions such as CRS and ICANS; Tumor-associated antigen escape leads to cancer recurrence (eg, CD19 escape); In chronic leukemia and non-Hodgkin lymphoma there is a need to improve the viability of the effect; Performance in solid tumors is not up to expectations; General-purpose CAR-T has not really gone to the clinic, and the cost of CAR-T treatment in previous generations
is too high.
