The first patient of the sky-high price of the magic drug "CAR-T" has been discharged from the hospital, and the second one has also been approved!

On September 3, the official website of the National Food and Drug Administration (NMPA) announced that WuXi Junuo 's CAR-T product targeting CD19, Recchio Lunsai injection (relma-cel, trade name: Benoda), has been officially approved

On September 3, the official website of the National Food and Drug Administration (NMPA) announced that WuXi Junuo 's CAR-T product targeting CD19, Recchio Lunsai injection (relma-cel, trade name: Benoda), has been officially approved CAR-T

This is WuXi Biotech's first innovative product approved for marketing, becoming China's second approved CAR-T product, and China's first CAR-T product of Category 1 biological products

Since the beginning of this year, domestic CAR-T products have developed rapidly.

The first approved CAR-T product in China is Fosun Kate's Yikaida (Akilunza injection), which was launched in June this year

According to online drug sales orders, the retail price of Yikaida is 1.

What is the effect of the 1.

What is the effect of the 1.
2 million high-priced medicine? What is the effect of the 1.
2 million high-priced medicine? According to The Paper, on August 26, Aunt Chen, a patient suffering from "diffuse large B-cell lymphoma", went through the discharge procedures from the Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
.
Aunt Chen from Ruijin Hospital also became the first patient in the country to be assessed for complete relief of symptoms after receiving CAR-T drug reinfusion treatment after the CAR-T technology was approved
.
Zhao Weilai, vice president of Ruijin Hospital and professor of hematology department, said that the treatment of this case will add great confidence to other patients with relapsed or refractory large B-cell lymphoma who will receive CAR-T treatment .
But when will ordinary patients take this "magic medicine" with the sky-high price of 1.
2 million ? Why is the price of this medicine so high? It is reported that the principle of this technology is to intensify the patient's immune cells in vitro and then return them to the body to build a stronger immune system to fight cancer cells .
Compared with traditional methods, immune it the advantage of using only one injection, 50% survival of patients from the original six months can be extended to four years .
The ins and outs of the sky-high price of the magic drug Yikaida 's ins and outs of the sky-high price magic drug Yikaida was formerly an anti-human CD19 CAR-T cell injection (YESCARTA) produced by Gilead of the United States, which was authorized by the company and transferred its technology to a domestic company for production .
YESCARTA was approved by the FDA in 2017, and the FDA’s pricing in the United States is as high as US$373,000.





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CAR-T cell therapy is considered to be a very promising cellular immune anti-cancer therapy.
The principle is to transform T cells to equip them with tumor chimeric antigen receptors that specifically recognize cancer cells, just like equipping a missile.
The high-precision navigator enables T cells to efficiently identify tumor cells in the body, and kill cancer cells through an immune killing mechanism, thereby achieving the effect of curing or relieving tumors .
Yikaida and its predecessor, YESCARTA, are second-generation CAR-T cells.
In addition to targeting CD19 molecules that attack tumor cells, they also add CD28 costimulatory areas.
This is also the key point that is different from the first-generation CAR-T cells.
Where .
Studies have confirmed that CAR-T cells containing CD28 costimulatory regions can attack tumor cells faster and have greater lethality .
When will the magical medicine be popularized? Two problems must be solved to popularize the magical medicine : first, expand the indications; second, reduce the price .
CAR-T cell therapy is currently limited to hematological tumors and has poor effect on solid tumors such as lung cancer and breast cancer .
Because solid tumors have a more complex immune microenvironment, they face the interference of various factors such as hypoxia, high acidity, and immune imbalance, and the expansion efficiency and maintenance time of CAR-T cells are greatly reduced .
For breast cancer to allow more cancer patients to use CAR-T cell therapy, it is necessary to have a breakthrough in theory and further innovation in technology .
In addition, it is difficult for Yikaida to significantly reduce prices in the short term, mainly because of the complex manufacturing process of the drug .
CAR-T cells need to be stored for a long time under liquid nitrogen, and CAR lentiviruses need to be transported in the cold chain at -80°C with a transport radius of no more than 4 hours, which greatly increases the cost.
 
 







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At present, the current domestic CAR-T experience in the United States is referenced .
The FDA mandates that the current domestic CAR-T experience in the United States is referenced .
The FDA mandates that CAR-T products can only be used in certified treatment centers, provided by trained doctors, and provided by trained doctors.
Most of these treatment centers are the blood and bone marrow transplantation departments of hospitals, and the entire The treatment process has established procedures and data requirements from cell collection, storage, transportation and reception .
Moreover, Yikaida currently has limited indications and the patient population is not extensive.
If it wants to recover the cost in the short term, it can only be sold at a high price .
Yikaida's predecessor, YESCARTA, has been included in the US medical insurance, so that patients need to pay about 20% of the original price, but it is still expensive .
Will Yikaida be included in China's medical insurance? Will Yikaida be included in China's medical insurance? Due to the increasing financial pressure on medical insurance in China in recent years, many drugs with a wider audience have not yet been included in medical insurance.
As a drug that needs to undergo phase 4 clinical trials after listing, medical insurance is unlikely to open a green channel for it in the short term .
The listing of Yikaida has opened a new door for the treatment of tumors in China and has important clinical value .
However, the current global CAR-T cell therapy is still in its infancy, and widespread adoption still has a long way to go .
I believe that when we gradually achieve complete technological independence, and as the country's financial strength continues to improve, more cancer patients will become beneficiaries of new therapies in the future .
At the current stage, ordinary people take 1.
2 million Bo for four years, is it worth it ? references: 


 
 

 


 References: 1.
Caron A Jacobson, et al.
Axicabtagene Ciloleucel in the Non-Trial Setting: Outcomes and Correlates of Response, Resistance, and Toxicity.
J Clin Oncol.
2020 Sep 20;38(27):3095-3106.
doi : 10.
1200/JCO.
19.
02103.
2, Irene Papadouli, et al.
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.
Oncologist.
2020 Oct; 25(10):894-902.
doi: 10.
1634/theoncologist.
2019-0646.


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