Domestic CAR-T therapy is on the market! How much room is there for cell therapy to reduce prices?

Cell immunotherapy has gone through a long history of development, and in recent years has ushered in a breakthrough.
to date, there are currently 366 CAR-T products in the global market and three CAR-T products approved for market, including Kite Pharmaceuticals' Yescarta and Tecartus and Novarma's Kymriah.
with Fosun Kate CAR-T products nearing approval, several CAR-T products are expected to be approved for sale in China in 2021, and the commercial application of cell therapy in China will be launched this year.
but the development of an emerging technology is bound to face many questions, how is CAR-T therapy priced? How much room for decline will there be in the future? What is the capacity? I. What are the difficulties in commercializing CAR-T therapy? Dr. Wang Yanbin of Beiheng Bio, said that cell therapy is still in a very early stage of development, each technology has its own history of development, cell therapy products since the first product launch in 2017, there have been 3 products approved, there will be more products.
and CAR-T as a highly personalized treatment, can not achieve mass production, high production costs, millions of treatment costs also lead to CAR-T therapy patient access restrictions.
Cell product manufacturing and application process is complex, the whole process needs to be sterile, toxin-free, no accidental pollution environment, cell extraction, separation, induction, amplification and return transmission and a series of processes need to be completed in a relatively short period of time, high requirements for technical personnel, storage and transportation requirements.
, the cell immunotherapy application must be a hospital and the hospital needs to be well prepared.
biopharmaceutical companies need to work in depth with hospitals to complete patient sample collection and cell return.
addition, the safety of CAR-T therapy needs to be further improved.
three CAR-T therapies currently approved have shown outstanding efficacy in clinical trials, but safety issues are also prominent.
The FDA has black-boxed warnings on all three treatments, including cytokine release syndrome (CRS) and neurotoxicity (NT), as well as allergic reactions, severe infections, prolonged blood cell reduction, propylene globulin reduction, secondary malignancies, and so on.
, CAR-T products are priced? How much room for decline will there be in the future? Novart Kymriah is priced at $475,000 and Gilead Yescarta is priced at $373,000, while in fact the total cost of CAR-T includes not only the price of the drug, but also a number of other medical expenses, such as lymphatic removal treatment and CAR-T adverse reaction management costs, hospitalization costs, and so on.
car-T therapy has significant advantages in treating blood diseases, millions of dollars in treatment costs are not affordable for most patients.
The pricing of domestic CAR-T therapy is about to be announced, according to Dr. Wang Yanbin revealed that the revival of Kate Yijililun injection may be reduced to less than 1 million yuan, but including high production costs, coupled with marketing costs and early research and development investment, the future price reduction space is limited.
and for innovative drugs, especially cell therapy drugs like CAR-T, it's not realistic to pay for health care in the short term, and it's unclear how many patients will be able to afford the nearly 1 million treatment costs.
bottleneck in self-contained CAR-T products is limited capacity, usually nearly 10,000 square GMP commercial production base, but the annual production capacity can only meet 1000 patients, it can be foreseen that the future of commercialization will face many problems and challenges.
cell therapy is now in the era of individual therapy, with the emergence of new technologies, the cost of future products down, we are still full of confidence.
the most critical to reducing costs and improving access is technological innovation, Dr. Wang said, and the generic CAR-T developed by Beiheng Bio can significantly reduce production costs by 15 times compared to the in-body CAR-T.
III, CAR-T product future trends For the future development trend of CAR-T therapy, Dr. Wang Yanbin mentioned the following points: 1, the development of self-body CAR-T to general purpose CAR-T generic CAR-T therapy, essentially an allogeneic CAR-T cell therapy, which does not require Separating T cells from the patient's body, using T cells donated by healthy volunteers, and removing genes such as T-cell TCR through gene editing technology, avoids the host's immune rejection of infusion car-T cells and the immune attack (GVHD) of allogeneic T-cells on host organs.
compared with the self-type CAR-T, the drug has low price, stable quality and high success rate in preparation, so it can achieve standardized batch preparation, timely supply and cost reduction.
2, breakthrough solid tumor efficacy bottleneck solid tumor CAR-T research is also a hot spot.
, there are fewer targets for cell immunotherapy with significant clinical effects, mainly concentrated in blood tumor targets such as CD19 and BCMA.
GPC3, Claudin18.2, NKG2D, etc. did not achieve the expected clinical efficacy at the target of solid tumor.
years, CAR-T therapy will also make breakthroughs in how to overcome the micro-environment and heterogeneity of solid tumors.
3, from single-drug to combined drug CAR-T combined drug therapy to enhance efficacy and prognosis is also a trend in the future.
For example, car-T is used in a combined way with immuno-checkpoint proteins (e.g. PD-1, PD-L1), lysolytic viruses, BTK inhibitors, etc., to improve CAR-T efficacy, improve safety, improve survival and quality of life.
addition, there are many other cell therapy products, not just CAR-T, the future CAR-NK, Til, TCR-T, CAR-M and so on may play a role in different adaptations, blooming.
the emergence of CAR-T therapy, which allows more patients to see the possibility of curing some diseases, offers options for diseases that are difficult to cure or that current treatment standards only alleviate symptoms to varying degrees.
For the Chinese market, the road exploration of cell gene therapy from technological innovation to industrialization and commercialization has just begun, and the problems of process development, regulatory policy, declaration experience, high cost and commercial development of CAR-T technology need to be solved.
The development of an emerging technology is bound to face many problems, but with the updating and iteration of technology, cell immunotherapy will win huge market potential and give patients hope of cure after breaking through general problems, solving safety problems, and expanding adaptive disorders.