breakthrough!

CAR-T cell therapy is mainly to transfer CAR-T cells cultured in vitro into the human body, and by activating T cells to attack and kill tumor cells in the patient's body, it has great potential in cancer
.
Data show that the CAR-T cell market will grow at an annual rate of 20.
2% and will be worth $20.
3 billion by 2027
.
In the face of the huge blue ocean of the market, coupled with the blessings of policies, talents, capital and other factors, domestic pharmaceutical companies continue to make efforts in the field of CAR-T cell therapy, and the enthusiasm for research and development is high.
Up to now, the number of CAR-T clinical trials carried out in China has There are more than 500 items
.
As the domestic track tends to be crowded in the future, a product that can be granted orphan drug designation (ODD) by the FDA often marks that the product has reached a new milestone, and it is enough to be recognized by the regulatory authorities for the product
.
In recent years, with the continuous rise of the strength of domestic innovative drug companies, more and more domestic CAR-T new drugs with independent property rights have received good news of FDA orphan drug qualification
.
Another domestic CAR-T product obtained orphan drug qualification Recently, Heyuan Bio and the Chinese Academy of Medical Sciences Hematology Hospital jointly announced that its self-developed targeting CD19 CAR-T drug CNCT19 cell injection has obtained orphan drug qualification granted by the US FDA , for the treatment of acute lymphoblastic leukemia
.
Previously, CNCT19 cell injection has been approved in China for the treatment of relapsed or refractory acute lymphoblastic leukemia and relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
.
And these two clinical trials have entered the registration phase 2 clinical stage
.
In December 2020, CNCT19 cell injection was included in the Center for Drug Evaluation of the China National Medical Products Administration for the treatment of relapsed or refractory acute lymphoblastic leukemia
.
Preliminary clinical research results show that CNCT19 cell injection has excellent efficacy and safety in both adults and children with r/r B-ALL patients
.
As CNCT19 cell injection obtained the FDA orphan drug designation, the industry believes that it may be beneficial to accelerate the clinical trial and registration process of the product in the United States, and it also means that this domestically-innovated drug will go from China to the world
.
Six months ago, the FDA granted the orphan drug designation of C-CAR039, a dual-target CAR-T product of Sibman Bio, for the treatment of follicular lymphoma, which gave follicular lymphoma patients a new dawn and is expected to usher in a new dawn.
good treatment
.
It is understood that in Western countries, follicular lymphoma is a common non-Hodgkin lymphoma subtype worldwide, affecting 2-4 people per 100,000 people, and its prevalence is steadily increasing
.
The data shows that the global follicular lymphoma treatment market is expected to grow at a rate of 7.
6%, from $2.
08 billion in 2019 to $3.
73 billion in 2027
.
In addition to being granted orphan drug status by the FDA, a number of domestic CAR-T cell therapies have received accelerated approval from the European Medicines Agency (EMA) in the past two years
.
For example, in November 2021, Keji Pharmaceutical announced that its self-developed CT041 had been granted priority drug status by the European Medicines Agency (EMA) for the treatment of gastric cancer/gastroesophageal junction cancer
.
It is reported that the product is a potential global first-in-class autologous CAR-T product targeting CLDN18.
2, which is being developed for CLDN18.
2-positive solid tumors such as gastric/gastroesophageal junction cancer and pancreatic cancer clinical treatment
.
At the same time, it is also the world's first solid tumor CAR-T product selected for the PRIME program
.
After the product was included in the priority channel, it will help shorten the review time of the drug application and benefit patients earlier
.
In February 2021, Legend Bio, a subsidiary of GenScript, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its biological products for the treatment of refractory and relapsed multiple myeloma1 Request for accelerated review of the Marketing Authorization Application (MAA) for the new drug cilta-cel
.
Previously, the product has obtained breakthrough therapy designation in the United States and priority drug designation and orphan drug designation by the European Commission, and was granted breakthrough therapy designation in China in August 2020
.
It can be seen that domestic CAR-T therapy is gradually ushering in new progress.
At present, the number of CAR-T cell therapies listed in the world is still very rare.
If domestic products successfully open up overseas markets, it will be very exciting.
new situation
.